Protocol Summary

CMCVAMC SPECIFIC PROTOCOL SUMMARY
Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center (CMCVAMC)
Institutional Review Board (IRB)
A. Protocol Title
1.
Full Protocol Title: Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal
Peer Notifications to Improve Statin Medication Adherence among Patients with Coronary
Artery Disease
2.

Date of Protocol Summary and Version #: Date 02/04/2016; Version # 6

B. Principal Investigator’s Full Name and Degree: Judith A. Long, MD
C. Co-Investigator’s Full Name and Degree: Kevin Volpp, MD, PhD, Judd Kessler, PhD, David Asch
MD, MBA, and Steven Marcus PhD
D. Financial Sponsor (Provide the name of the agency, organization, company or person providing
funds for the research study.) Center for Evaluation of Patient Care Aligned Teams
E. Grant (Provide the name of individual who holds the grant and the grant number, if applicable.) N/A
F. Protocol Number (Provide the financial sponsor’s protocol number, if applicable.) Not Applicable
G. Institution(s) responsible for the project:
1.
For single-site studies - CMCVAMC is the only institution involved. Yes
No
2.
For multi-center studies.
2.1. CMCVAMC is the Coordinating Center in which the PI is the lead investigator. Yes
N/A
2.2. Provide the name of the Coordinating Center. Yes
No
N/A
2.3. List the name of the other sites involved.
2.4. Provide the FWA numbers for each of the other sites involved.

No

THE FOLLOWING INFORMATION MUST BE CMCVAMC-SPECIFIC, THAT IS, SPECIFIC TO WHAT
WILL BE DONE WITH CMCVAMC-RECRUITED VETERANS.
H. Background and Significance (Describe succinctly and clearly the past findings which justify the
plan for this project. A summary of the relevant literature in the area of interest and reports of
previous studies should be included.) Improving patient medication adherence remains a major
challenge in chronic disease management. In the United States, 33 to 69 percent of
medication related hospital admissions are due to poor medication adherence – at a cost in
excess of $100 billion a year. In fact, one year after hospitalization for an acute coronary
syndrome, nearly half of patients prescribed statins stop taking them. 1 Despite the
importance of medication adherence, we have few effective tools to help patients improve
taking their medications.
One strategy to improve medication adherence is using newer technology to make
engagement with patients significantly easier and more immediate. Devices such as
Bluetooth enabled pill bottle caps can remind patients with daily alarms, monitor adherence,
and create feedback reports on how well patients are doing in adherence to medications.
Another strategy to engage patients is to recruit family, friends, and peers to create a social
support networks that activate a patient to taking their medications. However, especially in
veteran populations, there are few empirical studies evaluating how best to use these
technologies and engage different support providers (family/friends/or peers) to improve
medication adherence.
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In March 2014, we amended the protocol inclusion criteria expanding eligible patients. The
amendment is to expand eligible patients for our study to those with poor adherence as
measured by a 16-month medication adherence rate (medication possession ratio - MPR) of
less than or equal to 80%. In our original IRB application we identified a population of eligible
patients based on an email communication. However, upon review VA chronic disease
warehouse we found that our original sample of patients with CAD and 6-month MPR of less
than 65% was limited to around 150 patients. In reviewing how the VA has calculated the
medication possession ratio in the Primary Care Almanac we found that they use a 16-month
period to calculate this adherence rate. In addition, previous literature identifies patients with
less than or equal to 80% MPR as non-adherent. To increase our sample size of patients we
are changing our protocol to recruit CAD patients with a 16-month MPR of less than or equal
to 80% MPR.
I.

Purpose of the Project (Clearly provide the purpose of this research project.) In this study, we
propose a randomized-control trial among veterans with coronary artery disease (CAD) and
poor adherence to statins to test if simple feedback notifications around patient adherence to
the individual or family/friends/or reciprocal partner can motivate patients to improved
medication adherence
This study will have three arms: 1. Usual care 2. Alarming pill bottle along with Individual
feedback report and 3. Alarming pill bottle along with Individual plus patient-selected
family/friend/or reciprocal partner feedback report. Adherence will be measured using a pill
bottle medication-monitoring device (Vitality GlowCaps) that can flash and ring to remind
people when they should take their medications, monitor adherence as well as help create
notifications for different parties. The notification includes a weekly feedback adherence
assessment report that will be received by the individual and either a patient-selected family
member/friend or reciprocal partner with poor adherence to statin medications.

J. Describe the Research Questions and Hypothesis(that is, what questions are you trying to
address by conducting the research.)
Primary Aim: To evaluate the impact of alarming pill bottles along with adherence feedback on
medication adherence.
H1: Those who have alarming pill bottles and are receiving individual feedback alone will have better
medication adherence at 3 months compared to usual care.
H2: Those who have alarming pill bottles and are receiving individual plus patient-selected
family/friend/or reciprocal peer feedback will have better patient medication adherence at 3 months
compared to usual care.
Secondary Aims
Aim 2: To evaluate the impact of alarming pill bottles and adherence feedback on patient
activation/engagement.
H3: At 3 months, those receiving individual feedback and patient-selected family/friend/or reciprocal
peer will have increased patient activation to a greater extent than usual care.
Aim 3: To evaluate the effect of patient-selected family/friend/or reciprocal peer feedback on
improving patient perception of social support.
H4: At 3 months, those receiving family/friend/ or reciprocal peer feedback will improve patient
perceived social support to a greater extent than usual care or individual notifications alone.
Exploratory Aims: Compare different feedback methods and persistent of effects.
H5: Those who receive individual with family/friend or individual plus reciprocal peer feedback will
have better patient medication adherence compared to individual notifications alone.
H6: At 6 months, those randomized to the feedback intervention arms will have will have better
patient medication adherence compared to usual care.
K. Primary Outcome Variable(s) (Define the primary outcome variable(s) used to support the study
objectives (e.g. if the objective is to show that treatment A is superior to treatment B in the treatment
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of subjects with essential hypertension, the primary outcome variable is blood pressure
measurement.) Adherence: Vitality GlowCaps will record when a pill bottle has been opened.
While this is an indirect measure of adherence it has less bias than self-reported measures of
adherence. Adherence will be measured using the following formula: [Number of times the
pill bottle was opened/(Number of times a day each medication is prescribed to be taken
multiplied by the total number of days in study)].
L. Secondary Outcome Variable(s) (Define the secondary outcome variables. Such measured
variables should also include the timing of measurement.) Patient Activation Measure Survey: We
will utilize the 13-item Patient Activation Measure (PAM) to measure an individual’s activation
level. This tool has been used in previous studies to predict self-efficacy for health behaviors,
such as exercise and medications adherence. Response categories for each item are strongly
agree, agree, disagree and strongly disagree. Responses are then scaled and transformed to a
score ranging from 0 to 100. These scores are correlated with four stages of activation. This
survey will be given at baseline, 3-months, and 6-months.
Social Support (MPSS): The multidimensional scale of perceived social support will be given at
baseline, 3-months, and 6-months. This is a 12-item questionnaire is a validated measure of
social support. For each item, respondents must choose one answer that reflects their
assessment of social support on a 7-point scale. The items divide into 3 main factors of
support: Family, Friends, and Significant other.
LDL levels: We will obtain baseline LDL levels for each patient prior to the intervention. In
addition to monitor impact of adherence to the statin medication we will obtain LDL levels
baseline and 6-month time periods for all patients.
M. Study Design and Methods:
1.
Is this a clinical trial?
YES
NO
1.1.
If yes, what type? Check all that apply.
Phase I
Phase II
Phase III
1.2.
If yes, this study must be registered on Clinicaltrials.gov.
2.

Phase IV

Design
2.1.
What research methods will be used in the project? Check all that apply.
Surveys/Questionnaires
Interviews
Audio Taping
Behavioral Observations
Chart Reviews
Video Taping
Focus Groups
Randomization
Double-Blind
Control Group
Placebo
Withhold/Delay Treatment
Specimen Collection
Deception
Telephone Survey
Other (Describe)
2.2.
Describe how randomization or other treatment assignment will be made. After
informed consent is obtained and the baseline interview is complete, participants
will be randomized. A research study statistician using a permutated block
randomization procedure will develop randomization lists of participants. The
program specialist will assign the patient to a study arm using the randomized
list of arm assignments. The primary investigators will be blinded to knowledge
of participant’s assigned intervention.

2.3.

We calculated our sample size for a 3-arm randomized study with a primary
outcome of adherence rate. We propose to randomize 224 patients (64 in Arm 1,
64 in Arm 2, and 96 in Arm 3). Assuming a 15% dropout this will yield 175 patients
for analysis (50 in Arm 1, 50 in Arm 2, and 75 in Arm 3) (see power analysis
section).
For retrospective research studies, provide the “look-back” period. (e.g., December 1,
1999 through December 31, 2008.) N/A

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3.

Study Duration
3.1.
Provide the estimated length of time to enroll all subjects and complete the study.
We want to enroll a total of 224 veterans with CAD and poor adherence to statin
medications. We project being able to enroll 8-10 people per week with a
program specialist. We project that it will take 6-7 months to complete enrollment
and another 6 months to complete follow-up for a total of 12-13 months. After
that we anticipate it will take an additional 1-2 months to complete the analysis.

3.2.

In August 2014, an amendment was submitted to allow for additional time to
recruit patients. Our current ability to enroll patients has ranged from 2-7 per
week.
Explain the expected duration of subject participation including any follow-up.
The active time for each participant will be 6 months. Figure 1 below depicts the
flow of participants.
Figure 1: Participant flow through the study

3.3.

4.

Specify the projected date of completion of the proposed study. If enrollment starts by
October 1st, 2013, we anticipate completion of the study by November 1st, 2014. In
August 2014, an amendment was submitted to extend IRB approval for an
additional year. We did not start recruitment until April 2014. We anticipate
completion of study by April 1st, 2015. In addition we anticipate an addition 3
months for analysis. We plan to complete of the study July 1st, 2015.

Drug Information (If not applicable state, “Not Applicable.”) Not applicable
4.1.
Specify if the drug or biological agent is:
4.1.1. FDA approved
4.1.2. Used for off-label purposes
4.1.3. Not yet FDA approved.
4.2.
Include the FDA Investigational New Drug (IND) number for all non-FDA approved and
off-label drugs, biological agents or nutritional supplements. If not applicable state, “Not
Applicable.”
4.3.
Provide all relevant information about the drug
4.4.
Explain any wash-out periods, rescue medications permitted and any type of
medications not permitted while enrolled in the study.
4.5.
Describe blinding and un-blinding procedures.
4.6.
Include the dosage, route of administration, previous use, and the safety and efficacy
information on any drug used for research purposes.
4.7.
Describe rationale for the dosage in this study.
4.8.
Justify why the risks are reasonable in relation to anticipated benefits and/or knowledge.
4.9.
4.10.

Describe where drug preparation will be done.
All drugs for CMCVAMC subjects must be dispensed through the VA investigational
pharmacy.

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4.11.
4.12.
4.13.
4.14.

5.

Describe where the study treatment will be administered.
Describe plan for tracking a non-compliant treatment study subject.
Summarize any pre-clinical data.
Describe the process for the storage, security, dispensing and return of an
investigational drug.

Investigational Device (If not applicable state, “Not Applicable.”) Not applicable
5.1.
The Investigational Device Exemption (IDE) number must be submitted for all significant
risk devices and if an IDE exists for a non-significant device.
5.2.
Significant Risk or Non-significant Risk - If a device is not approved by the FDA, specify
whether or not the sponsor has determined this device to be a “significant risk” or “nonsignificant risk” as defined by the FDA.
5.3.
Provide all relevant information about the device.
5.4.
Describe blinding and un-blinding procedures.
5.5.
Specify if device is:
5.5.1. FDA approved
5.5.2. Used for off-label purposes
5.5.3. Not yet FDA approved.
5.6.
Explain if the investigational device will be delivered and/or stored by the Principal
Investigator or Pharmacy Services.
5.7.
Describe the process for the storage, security, dispensing and return of an
investigational device.
5.8.
For research involving an investigational device, describe the SOP or plan for device
control.
5.9.
Address how the device will be stored in such a way that only research staff associated
with the protocol will have access to the device.
5.10. Describe measures that will be put into place to ensure that the device will only be used
in participants of this research protocol.

N. Does this project involve international research?
YES
NO
1.
For further instructions refer to VHA Directive 2005-050, Requirements for Conducting VAApproved International Research Involving Human Subjects, Human Biological Specimens, or
Human Data
2.
VHA Handbook 1200.05 definition of international research - VA international research is any
VA-approved research conducted at international sites (not within the United States (U.S.), its
territories, or Commonwealths); any VA-approved research using either human biological
specimens (identified, de-identified, or coded) or human data (identified, de-identified, or
coded) originating from international sites; or any VA-approved research sending such
specimens or data out of the U.S. (see par. 56). NOTE: For the purposes of this Handbook,
research conducted at U.S. military bases, ships, or embassies is not considered international
research.
O. Study Procedure
1.
Study Procedures
1.1.
Outline all study procedures - (If necessary, include a table or flow chart, showing the
schedule of the procedures and interactions. Distinguish between interventions that are
experimental and carried out for research purposes vs. those that are considered
standard of care. Routine procedures that are performed solely for research purposes
should also be identified.) Overview: We will perform a randomized controlled trial
with three arms. The ultimate aim of this type of study is to enhance efforts by
Patient Care Aligned Teams (PACT) to improve medication adherence to statin
medications among Veterans.

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Patients and Settings: We will enroll Veterans with CAD and poor adherence to
statin medications who receive their care from the Corporal Michael J. Crescenz
VA Medical Center (CMCVAMC). Veterans between the ages of 30 and 75 will be
eligible for participation. There will be 3 arms: 1. Usual care 2. Individual
feedback report alone and 3. Individual plus patient-selected family/friend/or
reciprocal peer feedback reports. To ensure that we are studying a population
who are most likely to benefit from improving medication adherence in the future,
we are enrolling Veterans who are prescribed a statin by their provider and have
a documented poor adherence as measured by a 6 month medication adherence
rate (Medication Possession Ration) of < 65%. Dr George Tzanis (Director of
Primary Care at CMCVAMC) has told us that he estimates that there are roughly
3,276 patients in Primary Care that meet this inclusion criteria. Due to an initial
small sample from a review of pharmacy data, an amendment was submitted in
March 2014, to expand eligible patients to those with poor adherence as
measured by a 16-month medication adherence rate (Medication Possession
Ratio) of less than or equal to 80%.
Potenial subjects will be identified by the Center for Evaluation of PACT
(CEPACT) through VISN 4 Data Warehouse (VDW). With IRB approval, CEPACT
will extract administrative, clinical and laboratory data through the VDW to
identify eligible patients for this intervention. The VDW is updated regularly and
thus an excellent source for up-to-date patient information. The identified
patients will be sent a letter describing the study and then called. Current
members of the PI’s investigation team have used this method to identify
Veterans with DM on many occasions – and has been successfully in enrolling
between 60-70% of those contacted. Veterans who agree to participate will be
invited into the Corporal Michael J. Crescenz VA to complete a consent
procedure, baseline survey, and have their blood drawn to determine baseline
LDL level at enrollment.
Procedures: As mentioned there will be 3 arms. Randomization into each arm is
described above.
Control (Arm 1): They will complete all planned surveys, interviews, and blood
draws (baseline, 3months, and 6 months). Patients will be given educational
material on the importance of adherence to statin medications. The GlowCaps
device will be explained and set to only record adherence.
Reminder/Individual Feedback (Arm 2): In addition to educational material on
adherence to statin medications, the research coordinator will review set-up of
personal reminders for the GlowCaps device which will be set to glow and buzz
when the medication is missed. In addition, subjects will receive information on
interpretation of the weekly adherence feedback report.
Subject-Selected Family/Friend/or Reciprocal Peer Notification (Arm 3): The
subject will be given educational material on the importance of adhering to statin
medications. The research coordinator will review set-up of alarm features of
GlowCaps device. Similar to Arm 2, subjects will be given information on
interpretation of weekly adherence feedback report. If the subject chooses a
family/friend, the family/friend will be called and provided information on the
interpretation of weekly adherence feedback report.
If the subject chooses a reciprocal peer, they will be assigned to another subject
who has made a similar choice.
Subjects selecting this choice will complete the informed consent and surveys at
the time of enrollment. The subject will be contacted after another subject has
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been randomized into this arm. At this time the program specialist will
coordinate a time to meet both subjects and review GlowCaps and interpretation
of weekly adherence feedback reports. Thus, subjects who select a peer will
have an extra research visit at the CMCVAMC.
An amendment was submitted in March 2014, to change the introduction of peers
from a face-to-face meeting to a introduction via telephone call. Once amendment
approval has been received, subjects in Arm 3, who choose a reciprocal peer, will
proceed as follows: If the subject is the 1st participant in the pair they will
complete the informed consent and baseline surveys at the time of enrollment. In
addition, the research coordinator will review set-up of alarm features of the
GlowCap Device. The 1st participant will be contacted by telephone when the
2nd participant who is randomized into this arm and chooses a reciprocal peer is
assigned. This meeting of peers will be coordinated by telephone conference
with the research coordinator. At this telephone conference, the research
coordinator will facilitate an introduction of the peers and review the weekly
adherence feedback report that will be exchanged to each partner. At the end of
this meeting the GlowCaps device will be turned on at this time. If the 1st
participant is unable to be reached the research coordinator will schedule a time
with both participants to meet via a teleconference.
All participants from each group will be called at 3 months post-enrollment to
complete social support and patient engagement surveys. At six months, they
will be seen to return device, complete survey questionnaire, and complete blood
test. This will complete the study period. If subjects do not come to the six
month visit, they will be contacted to return for the visit by program specialist. At
six months the GlowCaps device and information will be turned off.
Data Collection: All participants will complete a baseline survey, a 3 month and 6
months survey and a blood draw at baseline and 6 months. Arms 2 and 3 will be
asked to respond to additional open-ended questions to better understand how
the Veteran interacted with the intervention technology and feedback reports.
The responses to these questions will be entered into the database by the
research coordinator. These questions are attached in a separate document titled
“Addition Qualitative Questions_GlowCaps”. Table 1 identifies data to be
collected at each time point and the source of the data.
For self-reported data we will use validated survey questions developed by the PI
or other researchers in the field.

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1.2.

1.3.

1.4.

Explain if and how the follow-up of subjects will occur. Follow-up will occur at three
months post-enrollment with a brief phone call, and at 6 months post-enrollment
with a visit at the Corporal Michael J. Crescenz VA Medical Center
Describe where, how and who will be conducting study procedures. Consent, study
surveys baseline and 6 months will occur at the Corporal Michael J. Crescenz VA
Medical Center and be performed by a program specialist. Evaluations of LDL
level will be performed by the Corporal Michael J. Crescenz VA Medical Center
lab.
If a survey study, specify the estimated amount of time that subjects will need to
complete the questionnaires/tools. Based on experience, consent will take about 30
minutes and the baseline survey will take approximately 45 minutes. Follow-up
visits will take about 60 minutes for survey completion. In total, we estimate the
baseline visit will take approximately 1.5-2 hours in total. The telephone call will
take approximately 30 minutes. The follow-up visit will take approximately 1 hour.
The lab usually expedites tests for research and we expect patients will need to
spend approximately 10 minutes getting their blood drawn. The total time
commitment for consent and data collection is estimated to be around 3.5 hours.

Table 2: Data Collection Step, Time to Complete and Mode of Collection
Number of Times to
Estimated Time to
Perform
Procedure
Complete
Consent

30 minutes

1 (in person)

Baseline Survey

45 minutes

1 (in person)

Lab Tests

10 minutes

2 (in person)

Follow-up Survey

30 minutes

1 (telephone)

Follow-up Survey

60 minutes

1 (in person)

Estimated Total Active Time
Arm 1/2/3
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210 minutes =~3.5 hours
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1.5.

2.

If a blood draw, specify the amount of blood to be drawn in milliliters and in
teaspoonfuls or tablespoonfuls and specify how often and where the blood will be
drawn. Blood draws will occur at the Corporal Michael J. Crescenz VAMC lab. We
anticipate a maximum of 5ccs or 1 teaspoon of blood will be required for each inperson visit at baseline and 6 months.

Data Collection (Include all questionnaires and survey tools with the submission.)
2.1.
Provide
2.1.1. the mode of data collection, e.g. telephone, in-person, questionnaire, interviews,
Data will be collected mostly by in-person or telephone survey and lab
tests. The participant will have data collected via GlowCaps to track daily
adherence to medications. See Table 2 for details.
2.1.2. the precise plan for how data is to be collected or acquired, Members of the
research team created the “Way to Health” platform to provide close
monitoring, feedback and reinforcement at a low cost to permit costeffective flexible, scalable infrastructure. The platform was built at the
University of Pennsylvania and the name derives from the ‘The Way to
Wealth’, an essay written by Benjamin Franklin, which described how
people can overcome difficulties in adopting good savings behaviors.
Way to Health aims to improve health behaviors and consists of a portal
with links to variety of peripheral devices (e.g., scales, pill bottles,
glucometers) for assessing health behaviors and outcomes; the capacity
to communicate back to patients using interactive voice recording; and
the ability to automate the delivery of feedback reports. For this study,
adherence reports will be sent to subjects (and if in “buddy group”,
reports will also be mailed to the buddy).
Once patients have consented to be in the study and have their data
managed by Way to Health (WTH), the WTH platform adherence tracking
information will be stored according to a unique, random, patient identifier
generated for the purposes of the study. To assure that subject, physician
and other informant confidentiality is preserved, individual identifiers
(such as name and medical record number) are stored in a single
password protected system that is accessible only to study research,
analysis and IT staff. This system is hosted onsite at the University of
Pennsylvania (UPenn) and is protected by a secure identification number
(ID). Any datasets and computer files that leave the firewall will be
stripped of all identifiers and individuals will be referred to by their study
ID. The study ID will also be used on all analytical files. An amendment
was submitted on August 2014, to transfer these analytical files to the VA
CHERP servers for further analysis. A detailed plan for transfer of these
coded files is outlined in the section entitled: Information Security.
The University of Pennsylvania Biomedical Informatics Consortium (BMIC)
is the hub for the hardware and database infrastructure. The data
collected for Way to Health based studies is stored in MySQL databases
on a BMIC-operated blade server environment devoted specifically to Way
to Health. The data center is housed in the Information Systems and
Computing at 3401 Walnut Street. All data are stored in a single relational
database, allowing researchers to correct mistakes. Every SQL
transaction, including accessing and changing data is logged for auditing
purposes. Once a participant is consented and enrolled in the study, data
are entered into the database through several different mechanisms. A
program specialist will manually enter subjects’ personal information and
responses to survey questions through a PHP-based web interface.
Researchers have a separate interface that allows them to manually enter

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data if needed. This function will be used to enter data on LDL levels. All
data collection and data entry done by the program specialists takes place
at the Corporal Michael J. Crescenz VA Medical Center. Data from
monitoring devices are uploaded automatically, imported from Vitality’s
web-based, password-protected platform. Vitality is the company that
makes the GlowCap electronic pill bottles. No personally identifiable
information is stored in Vitality’s platform, only subject numbers and the
cap data from the electronic pill bottles. The only data that is imported
from Vitality’s platform into Way to Health are the daily records of whether
the cap was opened, which is how we will measure medication adherence.
Datasets are blinded of all personally identifiable information when
exported for analysis. The web application automatically removes all
identifiers when a member of the research team requests an analytic
dataset. The only people with access to identifiable participant
information are pre-specified Program Specialists responsible for
contacting participants. Personal information and research data will be
stored in separate SQL tables and will be linked by a computer-generated
ID number. All data for this project will be stored on the secure/firewalled
servers for the BMIC Data Center, in data files that will be protected by
multiple password layers. These data servers are maintained in a guarded
facility behind several locked doors, with very limited physical access
rights. They are also cyber-protected by extensive firewalls and multiple
layers of communication encryption. Electronic access rights are
carefully controlled by UPenn system managers. We believe this multilayer system of data security, identical to the system protecting the
University of Pennsylvania Health System medical records, greatly
minimizes the risk of loss of privacy.
For example, data will be coded and Vitality is provided only with a study
ID and a “cap ID(s)” for each participant. The Way to Health web
developers have built an application that securely and automatically
transmits data from the Vitality server to the Way to Health study server.
All of the data is encrypted via https and transmitted from Vitality to the
Way to Health web application and secure Penn servers. A HIPAA
Business Associate Agreement is in place between this vender and Penn.
Feedback reports are generated within the Way to Health platform and will
be mailed to participants.
A program specialist will be read to participants survey questions and
answers will either be directly input into a computer database or written
onto paper forms and then transferred to a database at a later time. Paper
records will be stored at CHERP behind an electronically locked entrance,
a key-locked door and in a key-locked cabinet.
Lab results will be obtained from the lab or via CPRS and entered into the
secure research database.
2.1.3. exact location where data will be collected, Corporal Michael J. Crescenz
VAMC and the Corporal Michael J. Crescenz VAMC Annex (for phone
derived data.)
2.1.4. exact location where data entry will take place. All data entry will occur either
at the Corporal Michael J. Crescenz VAMC or the Corporal Michael J.
Crescenz VAMC Annex. Paper files for the study will be housed at the
Corporal Michael J. Crescenz VAMC annex in locked filing cabinets. The
data center and server for the Way to Health Platforms is at 3401 Walnut
Street, Philadelphia, PA.
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2.2.

2.3.

2.1.5. the “title” of individual(s) collecting the data and analyzing the data, e.g. principal
investigator, research coordinator. A research coordinator will be collecting
data and entering it into the database. The Principal investigator and
Statistician/Programmer will be analyzing the data. Identifiable data will
not be removed from Way to Health Platform. Access to identifiable data
will be limited to those who require access including the program
specialist, principal investigator, and the Statistician/Programmer.
Provide a time line for each aspect of the study. Baseline: Obtain consent, complete
baseline survey, randomize, obtain blood. 3 months: Complete follow up survey,
turn-off all feedback notifications. 6 months: Complete follow up survey, collect
blood.
Chart/Records/Data Review (retrospective and/or prospective)
2.3.1. Provide the planned or approximate number of charts/records/data to be
accessed
2.3.1.1.
CMCVAMC - Given previous experience we anticipate having to
screen between 1,600 and 1,700 charts to identify 224 people
who will be eligible and willing to participate.
2.3.1.2.
Other site
2.3.2. Does this protocol employ an Honest Broker?
YES
NO
2.3.2.1.
If yes, provide name of individual.
2.3.2.2.
If no, explain who will access the charts/records.
2.3.2.3.
Describe from what database charts/records/data will be accessed.

3.

Future Use of Data and Re-Contact, if applicable. Not Applicable
3.1
If any of the participant’s data are going to be retained after the study for future
research, the following information must be provided to the participant:
3.3.1. Where will the data be stored?
3.3.2. Who will have access to the data?
3.2
If the subject is going to be re-contacted in the future about participating in future
research, this must be specified. Describe the circumstances under which the
participant would be re-contacted whether within the VA or outside the VA.
3.2.1 If subjects will receive aggregate study results at the end of the study, the
informed consent document must contain this information.

4.

Specimen Collection
4.1.
Give the source of all specimens and whether they were collected for research, treatment or
diagnosis. Blood will be drawn to assess direct LDL on two different occasions for
research purposes. Treatment decisions will not be based on results by the research
team.
4.2.
State where specimens will be stored, secured and when discarded. Specimens will be
drawn by the Corporal Michael J. Crescenz VA Medical Center lab and disposed of
appropriately. We will not be storing blood for future use.
4.3.
Explain how destruction of samples will be substantiated. The Corporal Michael J.
Crescenz VA Medical Center lab will handle blood samples in the same way they
handle samples for routine clinical care and subject to the oversight of routine
clinical care.

P. Genetic Testing, if applicable
1.
Explain if the study is looking for an association between a genetic marker and a specific
disease or condition, but at this point it is not clear if the genetic marker has predictive value.
Not Applicable
1.1.
The uncertainty regarding the predictive value of the genetic marker is such that studies
in this category will not involve participant counseling.
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1.2.

1.3.

1.4.

1.5.

1.6.

Describe if the study is based on the premise that a link between a genetic marker and
a specific disease or condition is such that the marker is clinically useful in predicting
the development of that specific disease or condition.
Will the subject be notified of the results and the provision for genetic counseling?
Yes
No
N/A
1.3.1. If yes, explain further.
If biological specimens are used in this protocol, please respond to the following
questions by checking the appropriate box:
YES NO N/A
a. Does the project involve genetic testing?
b. Will specimens be kept for future, unspecified use?
c. Will samples be made anonymous to maintain confidentiality?
(Instructions: Note: If there is a link, it is not anonymous. Coding
is not anonymous.
d. Will specimens be destroyed after the project-specific use is
completed?
e. Will specimens be sold in the future?
f. Will subjects be paid for their specimens now or in the future?
g. Will subjects be informed of the results of the specimen
testing?
h. Are there any implications for family members based on
specimen testing results? (If yes, they may be participants.)
i. Will subjects be informed of results obtained from their DNA?
Will specimens be de-identified?
YES
NO
N/A
1.5.1. If yes, please describe the procedures to be used.
1.5.2. Include at what point in the process the specimens will be de-identified.
Describe what measures will be taken to minimize the following risks from breaches of
confidentiality and privacy resulting from participating in THIS aspect of the research
project:
1.6.1. physical
1.6.2. psychological
1.6.3. financial
1.6.4. social
1.6.5. legal harm

Q. Banking of Collected Specimens
1.
Will collected specimens be banked?
YES
NO
N/A
1.1.
IF BANKING SPECIMENS, IT MUST BE AT AN APPROVED VA REPOSITORY. (For
additional information, refer to VHA Handbook 1200.12, Use of Data and Data
Repositories in VHA Research - March 9, 2009.)
1.2.
If yes, specify the location where specimens will be banked.
1.2.1. If the location is a non-VA site, has the mandatory approval from the Chief
Officer of Research and Development (CRADO) been obtained through
submission of a tissue banking application (VA Form 10-0436 - Off-site
Application for an Off-site Tissue Banking Waiver)?
YES
NO
N/A
1.2.2. If applicable, attach a copy of the VA Form 10-0436
1.3.
Explain how destruction of banked samples will be substantiated.
R. Subject Recruitment (characteristics of the study population): The Veterans Health Affairs(VHA)
health care system is the nation’s largest integrated delivery health network. The VHA
provides primary care for over five million veterans across 160 hospital-based and 783
community-based primary care clinics. Because veterans are typically older, sicker, and

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more socioeconomically vulnerable than patients outside VHA, this population is in need of
better tools to monitor and improve patient adherence to medications.
1.
Provide the planned or targeted enrollment at:
1.1.
CMCVAMC - 224 total participants
1.2.
Other sites 1.3.
Not applicable; chart review or use of previously collected data 2.

Screening and/or Eligibility Requirements
2.1.
Describe and provide justification for:
Inclusion criteria - All participants will have a diagnosis of CAD. To be eligible they
must be between the ages of 30-75 years of age-to ensure we are targeting those
most likely to benefit from improving control to these medications. Patients must
have been prescribed a statin by their provider and a documented poor
adherence as measured by a 6-month medication adherence rate (Medication
Possession Ratio) of <65%. In a recent review of primary care patients in the
Corporal Michael J. Crescenz VAMC roughly 3,276 patients met these inclusion
criteria. An amendment was submitted in March 2014, to expand eligible patient
to those with poor adherence as measured by a 16-month medication possession
ratio of less than or equal to 80%.
2.1.1.
Exclusion criteria - Due to the use of the medication adherence reminder
device, patients must speak English, have a home address, telephone
number, and be willing and able to identify a friend or family member.
We will exclude patients with active substance abuse, significant
hearing loss, or reduced cognitive ability as determined from the
patient’s problem list.
2.1.2.
List all screening and/or eligibility requirements. We will electronically
create a list of CMCVAMC patients with diagnosis codes for coronary
artery disease (CAD) (ICD-9 code 414). Among these patient will review
pharmacy database to identify patients with <65% of medication
possession ratio in the previous 6 months. An amendment was
submitted in March 2014, to expand eligible patient to those with poor
adherence as measured by a 16-month medication possession ratio of
less than or equal to 80%.
2.2.
We will exclude people if their current age is ≤ 30 and > 75 years of age. We will
then review the list and determine who qualifies. Letters will be sent to potential
participants letting them know that they may be eligible for a study with a brief
description of the study and give them a number of they would like to learn more
or to request no further contact. We will also notify potential participants that if
we do not hear from them we will give them a call in the following weeks.

2.3.

2.4.
3.

If the identified subject has not responded to either the mailed or 2 separate
recruitment phone calls their information will be deleted from a list of potential
participants.
Explain any special test or evaluations potential subjects may have to undergo before
they are actually determined to be eligible for the study. When patients are contacted
over the phone we will give them additional description of the study. If interested
we will review the exclusion criteria with the participation – and exclude those
who have the above exclusions.
Not Applicable; subjects not recruited; chart review.

If applicable, indicate what populations will be targeted for recruitment as participants.
Check all that apply.
Males
Females
Inpatients

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3.1.

3.2.

3.3.

4.

Outpatients
VA Employees
Non-English Speaking**
Veteran Family members***
Non-Veterans***
Other (Specify)
Not Applicable, chart review
**For non-English speaking subjects - If an investigator proposes to use a participant
population that does not speak or read English, a copy of the translated document, as
well as the English version, needs to be forwarded to the IRB for approval. Translator
certification is also required.
***If non-veterans will be recruited for this study, explain why sufficient veterans are not
available to participate in the project [VHA Handbook 1200.5, paragraph 16a]. Veteran’s
spouses/partners, caregivers, etc. are considered non-veterans for the purposes of this
study.
***Has approval to recruit non-veterans been received from the ACOS/R&D and
Medical Center Director?
3.3.1.
Not Applicable
3.3.2.
Pending (Non-veteran forms should be used. IRB office will obtain
approval from ACOS/R&D and Medical Center Director.)

Does this project target a specific race or ethnic group as participants?
If yes, check all that apply.
Race
Ethnicity
American Indian or Alaskan Native
Hispanic or Latino
Asian
Not Hispanic or Latino
Black or African American
Other
Native Hawaiian or other Pacific
Islander
Black, not of Hispanic origin
White, not of Hispanic origin
Other
4.1.
Provide justification why this/these group(s) was/were chosen.

YES

NO

5.

What is the age range of participants? Check all that apply.
Children (Under 18) Requires Waiver from CRADO (VHA
Directive 2001-028, Research Involving Children)
Young Adults (18-21)
Adults (22-65)
Seniors (Over 65)
Over 89
Not Applicable, chart review

6.

Are there specific reasons why certain populations (i.e., age, gender or ethnic groups)
are excluded as participants?
YES
NO
N/A
6.1.
If yes, specify reasons. Subjects who are greater than 76 may not benefit from
improvements in statin medication adherence. In addition, subjects less than 30
may have other genetic contributing factors for elevated LDL levels.

7.

Does the project require enrollment of the following classes of participants?
YES NO
a. Employees
b. Individuals with impaired decision making capability
c. Pregnant women

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d.
e.
f.
g.
7.1.
7.2.

8.

Economically and/or educationally disadvantaged persons
Prisoners
Illiterate, limited, or no English language proficiency
Terminally ill patients
If applicable, what is the justification for including any of the above classes of
participants in the project?
If the project requires enrolling any of the above classes of participants describe any
project-specific measures or special considerations, steps, or safeguards to ensure that
these individuals are adequately protected.

Describe the exact plan how subjects will be identified and recruited for the study.
Participants will be identified using the VISN 4 Data Warehouse (VDW). With IRB
approval, CEPACT will extract administrative, clinical, and laboratory data from VDW on
an ongoing basis. All eligible patients identified as meeting inclusion criteria will be
sent a letter notifying them about the existence of the study, our intention to contact
them, and our contact number in case they have questions. Mailings will be followed up
with phone calls. This will be an ongoing process until recruitment is complete.
Veterans who agree to participate will be invited to the Corporal Michael J. Crescenz VA
to complete a consent procedure, baseline demographic and social support survey, and
initial blood test (direct LDL). In addition, all subjects will receive one-on-one training
session on use of GlowCaps device.
8.1.
Discuss methods, e.g., referrals from physician offices, clinics, programs, or through
advertisements and brochures.
8.2.
If using a clinic, be specific about who will identify the potential subject and how that
information will be transmitted to the research staff.
8.3.
If snowball method will be used, discuss the process and how the first individuals will be
recruited.
8.4.
Describe how information will be disseminated to subjects, e.g. handouts, brochures,
flyers and advertisements (include all recruitment materials with this submission).
8.5.

9.

Participants will be given a copy of the Volunteering in Research brochure and
Notice of Privacy Practices, which explains what participants are expected to do
in VA authorized studies

Informed Consent
9.1.
Informed Consent will not be sought.
9.2.
Written informed consent from participants (VA Form 10-1086 is attached).
9.3.
Written informed consent from participants’ legally authorized representative (LAR) as
required by VA policy and/or applicable state laws (VA Form 10-1086 is attached).
9.4.
Request Waiver of Documentation of Informed Consent
9.5.
List the title of the key personnel involved in the following activities:
9.5.1.
Person Obtaining Consent
9.5.1.1.
Provide the title(s) of individual(s) Principal Investigator and/or
Program Specialist
9.5.1.2.
Type of training received to perform this process Program
Specialist will have completed HIPPA and CITI research
trainings on clinical research
9.5.2.
Pre-Recruitment Screening (the use of medical records and other data
bases to determine populations and individuals eligible for the study),
Database Programmer and Program Specialist
9.5.3.
Recruitment Process (the process in which individuals are contacted and
first introduced to the study and to the possibility of participating as subjects),
Program Specialist

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9.5.4.

Informed Consent Process (the process by which recruited subjects are
fully informed about participating in the study and then formally give their
voluntary consent for participating), Principal Investigator and/or Program
Specialist
9.5.5.
Screening of Recruited Subjects (those activities in the protocol in which a
final determination of eligibility of prospective subjects is made during the
early phases of the study, using laboratory data, inclusion and exclusion
criteria, and other person-specific information), Program Specialist and
Principal Investigator
9.5.6.
Include the breakdown of each individual’s responsibilities:
9.5.6.1.
Principal Investigator, Judith A. Long, MD will be responsible
for the oversight of this entire study
9.5.6.2.
Co-Principal Investigator, David Asch MD, MBA and Kevin
Volpp MD PhD are co-investigators who have created Way to
Health Platform, Judd Kessler PhD will provide expertise on
social incentives, and Steven Marcus PhD will be provider
expertise on conducting VA related clinical trials
9.5.6.3.
Research Coordinator (Program Specialist Pre-Recruitment
Screening, Recruitment Process, Screening of Recruited
Subjects , Obtaining informed consent
9.5.6.4.
Additional research staff by title, Statistician
9.6.
Will informed consent be obtained from potential subjects prior to determining eligibility?
YES
NO
N/A
9.6.1.
If no, provide justification and a HIPAA Waiver of Individual Authorization for
Disclosure of Protected Health Information. To make the recruitment
process efficient we will need to screen for patients with CAD in the
correct age range, with poor adherence to medications as described
above. Please see the attached HIPAA Waiver of Individual
Authorization for Disclosure of Protected Health Information for
approval of this activity.
9.7.
Define when a subject is enrolled into the study, e.g. after the subject signs the
informed consent or after randomized to treatment. After the informed consent and
HIPAA authorization are complete the patient will be enrolled in the study
9.8.
Describe:
9.8.1.
The process when informed consent will be obtained and protecting patients’
privacy. Informed consent will be obtained at the Corporal Michael J.
Crescenz VA Medical Center in a semi-private room with cubicles. This
room usually has only one person working in it at a time and thus
affords privacy. All study materials including informed consent forms
will be read to the participant.
9.8.2.
Any waiting period between informing the prospective participant and
obtaining consent. No
9.8.3.
Steps taken to minimize the possibility of coercion or undue influence. The
consent process will explain how participation is voluntary and will not
affect the care or services the patient is eligible from the Corporal
Michael J. Crescenz VA Medical System. Participants will be told they
can withdraw from the study at any time. Participants will only receive a
reimbursement to defray the costs of the participant’s time.
9.9.
Provide the language
9.9.1.
used by those obtaining consent English
9.9.2
understood by the prospective participant or the legally authorized
representative English
9.10. Provide location where informed consent will be obtained. The Corporal Michael J.
Crescenz VA Medical Center.

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10.

Waiver or Alteration of Informed Consent Requirements/Waiver of Requirement to
Obtain Documentation of Informed Consent
10.1. Are you requesting a waiver or alteration of informed consent? (Check all that apply)
10.1.1.
No
10.1.2.
Yes; provide justification.
To make the recruitment process efficient we
will need to screen for patients with CAD in the correct age range, with
poor adherence to medications as described above. Please see the
attached HIPAA Waiver of Individual Authorization for Disclosure of
Protected Health Information for approval of this activity.
10.1.3.
Yes; for recruitment purposes only.
10.2. Are you requesting a waiver to obtain documentation of informed consent?
10.2.1.
No
10.2.2.
Yes; provide justification.

S. Compensation (The amount of compensation may not constitute an undue inducement to participate in
the research.)
1.
Summarize any financial compensation that will be offered to subjects. All subjects, regardless
of the arm, will receive $50 for each in person visit (baseline, 6 months). Participants
will also receive an additional $25 for completion of telephone survey at 3 months. An
amendment was submitted in March 2014 to change payment form from cash to gift
cards to CVS and/or Rite Aid depending on availability. For those patients who were
enrolled prior to amendment approval, cash will still be provided. Once amendment
approval is received, reimbursement will be in the form of gift cards.
2.
Provide the schedule for compensation.
•
All enrollees are eligible for compensation up to $125 for completion of this study.
•
Subjects will receive $50 for completion of baseline survey and blood draw at visit
one.
•
They will receive $75 at the second visit (at six months) if they complete the phone
research questionnaire at 3months. If the phone questionnaire is not completed
they will receive $50 at the second visit.
•
An amendment was submitted in March 2014 to change payment form from cash to
gift cards. For those patients who were enrolled prior to amendment approval, cash
will still be provided. Once amendment approval is received, reimbursement will be
in the form of gift cards. The schedule for compensation will remain as explained
above.
2.1.
Per study visit or session. $50 in person, $25 for 3 month telephone survey/ PostAmendment: $50 gift card in person visit, $25 gift card for 3 month telephone survey
2.2.
Total amount for entire participation. $125
3.
Explain how compensation will be provided via cash, voucher, gift card, etc.
•
Participants will be given vouchers which they can then redeem for cash from the
Corporal Michael J. Crescenz VA cashier.
•
Post Amendment: Participants will be given gift cards equivalent to the amount
specified above for the baseline and follow-up visits. This will be given to the
Veteran by the research coordinator and recorded in a tracking database.
4.
If financial compensation will be prorated, explain the process. N/A
5.
Not Applicable T. Withdrawal/Early Withdrawal
1.
Describe how and when a subject may withdrawal from the study. Subjects may withdraw at
anytime. Any request may either be expressed verbally or in writing.
2.
Provide procedures for the orderly termination of participation by the participant and if any
consequences would result from early withdrawal from the study. There will be no
consequence of early withdraw. After submitting a request to withdraw or written or
verbally the study participation will be terminated.
3.
Explain if survival data is required. If so, clarify how data will be obtained. N/A
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4.

Not Applicable; subjects not recruited; chart review.

U. Risk/Benefit Assessment
1.
Potential Study Risks
1.1.
Describe and assess all of the following risks that may be associated with the research:
1.1.1. Physical Minimal - We are asking that all subjects get a blood test to
measure LDL levels from the lab at each study visit. The blood test
consists of inserting a needle into the arm and taking about a teaspoon
of blood. Subjects may experience mild pain and swelling where the
needle enters the skin and vein, bruising, infection and possibly fainting.
1.1.2. Psychological Minimal - Subjects may feel uncomfortable or embarrassed
that someone else knows information about when they are taking their
medication and that they may not be taking it as often as you should be
1.1.3. Social Minimal
1.1.4. Economic Minimal
1.1.5. Monetary Minimal
1.1.6. Legal Minimal
1.1.7. Loss of confidentiality Minimal - If subjects are in the Buddy group, there is
a risk that the buddy may reveal the subject’s name and phone number
as well as information from their statin pill bottle reports to another
person. We will instruct the buddy not to share any information with
others. There is a risk that information could be accidentally released.
We take great efforts to maintain confidential information
1.1.8. Assess the likelihood and seriousness of such risks. Minimal
1.1.9. Other N/A.
1.2.
Specify what steps will be taken to minimize these risks. Subjects will need to
complete a mini-quiz after completing the informed consent to assure the
researchers they understand the study. Those who fail the mini-quiz will be given
$50 for the in person visit but not enrolled in the study. All participants will be
notified that participation is voluntary and they can terminate participation at any
time. They will also be notified that their care will not be affected by their
participation.
The greatest risk to patients will be loss of confidentiality. Patient selected
family, friend, or reciprocal peer will be informed that information around
medication adherence is confidential and should not be shared. Participants will
need to provide a current home address to receive adherence feedback reports.

1.3.
1.4.

2.

Tracking data with identifiable information will be kept in a different data base
than the analytic data base. All databases will be password protected and reside
on the University of Pennsylvania WTH platform. Neither data base will be
removed from the WTH server and will be behind VA firewalls. Paper files will be
kept in locked filing cabinets and will not leave the Corporal Michael J. Crescenz
VA or Annex. Papers will be kept in locked files when not being actively used.
All participants will be given a study ID number and this will be the only link
between the analytic files and the tracking database.
If methods of research create potential risks, describe other methods, if any, that were
considered and why they will not be used. N/A
If chart review, breach of confidentiality is always a concern. Specify what steps will be
taken to minimize these risks. Charts will only be reviewed to determine if a
potential subject may be eligible for the study. Only IRB approved study
personnel will access charts from VA computers during working hours.
Abstraction will be limited to determine eligibility only.

Potential Study Benefits

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2.1.

2.2.

3.

Assess the potential benefits to be gained by the individual subject, as well as benefits
that may accrue to society in general as a result of the planned work. Using
telemonitoring and feedback mechanisms for medication adherence can engage
potential participants in those arms of the study to improve medication
adherence. This study may lead to strategies that enhance adherence to
medications. Adherence to medications can reduce the risk of an individual
patient of having a heart attack – and on a population level has the ability to
improve the quality and reduce the cost of healthcare. This study has the
potential to add to our knowledge about how to use feedback reports and nonfinancial incentives to improve medication adherence.
If the subject does not receive any direct benefit, then it must be stated here and in the
consent form. While we hope that subjects in some arms of the study might
receive benefit it is likely that some participants will not benefit especially those
who are randomized to usual care

Alternate Procedures
3.1
Describe the alternatives available to the subject outside the research context. N/A
3.2
If none, state that the alternative is not to take part in this research study at all. The
only alternative is to not take part in the research study.

V. Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) (All Phase III
studies are required to have a DSMB. However, the IRB has the right to require a DSMB with any
study.)
1. Will an independent DSMB or DMC oversee the project?
YES
NO
N/A
2.1. If yes, please provide contact information for the DSMB or DMC or Coordinating Center
Representative and attach a copy of the charter.
Name:
Phone Number:
Title:
E-mail:
2.

If a DSMB or DMC will not monitor this study, who will monitor this study? Check all that
apply.
Principal Investigator
Sponsor
VA Cooperative Studies Program
Safety monitoring committee

W. Data Monitoring (Monitoring plans describe how a monitor, independent of the study team, regularly
inspects study records to ensure the study is adhering to the study protocol and applicable research
regulations and CMCVAMC requirements. Monitoring plans do not necessarily require the use of an
independent Data and Safety Monitoring Board (DSMB). Such independent boards are usually
reserved for high-risk phase I studies, or large, multi-center phase III trials. Federally funded studies
may require the use of an independent DSMB.)
1.
Describe the data monitoring plan. (All protocols must have a data monitoring plan
appropriate for the potential risks and the complexity of the study.) All serious adverse events
will be reviewed by the PI and reported to the IRB. We do not expect events to differ by
arm based on our prior research.
Data not directly entered will be double entered to ensure fidelity. Paper consents will
be reviewed routinely for completeness. All files will be regularly maintained and
available for inspection upon request.
2.

Describe how protocol deviations, adverse events, serious adverse events, breaches of
confidentiality, unanticipated adverse device effect (UADE), and unanticipated or
unexpected problems will be reported to the CMCVAMC IRB and sponsor. (Refer to the
CMCVAMC IRB Standard Operating Procedure (SOP) Manual for reporting guidelines.)
Breaches of confidentiality will be reported within 24 hours of our awareness of said

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breach. Protocol deviations, adverse events, serious adverse events, breaches of
confidentiality, unanticipated adverse device effect (UADE), and unanticipated or
unexpected problems will be reported following the guidelines in the CMCVAMC IRB
SOP.
2.1.
Describe the management of information obtain that might be relevant to participant
protections such as:
2.1.1. Unanticipated problems involving risks to subjects or others - This is a low
risk study. However, if unanticipated problems arise the study team will
review them and report them immediately to the CMCVAMC IRB. If there
are serious concerns about risks to subjects or others the study will be
halted while an external group reviews the study to determine the risks.
2.1.2. Interim results - We are not planning an interim analysis
2.1.3. Protocol modifications - If we desire to modify the protocol we will submit a
modification to the IRB and not act on the modification until it has been
approved.
3.

If applicable, define the plan for subjects if research shows results such as:
3.1.
Depression n/a
3.2.
Suicide n/a
3.3.
Abuse n/a

4.

Statistical Analysis
4.1.
Include statistical power calculations and the assumptions made in making these
calculations. Our sample size was determined using a power calculation where we
seek to have 80% power to detect a Cohen’s d=0.6 corresponding to a moderateto-large effect of our intervention on the outcomes of interest. We assume
alpha=.025 to account for multiple comparisons associated with the comparison
of each of the two intervention arms with the control arm (i.e. alpha=.05/2=.025).
Our power calculation suggests that a sample of 50 subjects in each of the three
arms of the study will achieve this goal. However, Arm 3 of the study may include
reciprocal pairs and, as such, the subjects cannot be considered to be
independent. We assume a relatively large Intra Cluster Correlation of ICC=0.5
between the reciprocal pairs. This translates to a design effect of 1.5 which, in
turn requires that the sample size for this arm be increased by 50% to n=75. We
conservatively allow for 15% attrition and so will propose to randomize 64
subjects in Arms 1 and 2, and 96 in arm 3. Because this is a pilot study, the study
was designed was to test if the intervention could detect an improved adherence
of 5% between the groups.
4.2.
Define plans for data and statistical analysis, including key elements of the statistical
plan, stopping rules and endpoints. We will test the primary hypotheses using an
unadjusted intent-to-treat analyses. Initial descriptive analysis of demographic
and baseline clinical characteristics for all study patients will be conducted,
including gender, age, race/ethnicity, income, education, type of statin
medication, and initial measures of social support. For specific aim 1 (H1, H2),
we will model using a one-way ANOVA model to test for differences the
continuous outcome of percent of total medications taken at 3 months with study
arm as the main independent predictor of interest. We will adjust for covariates
not balanced at baseline. . For specific aim 2 and specific aim 3 (H3,H4), we will
model using a one-way ANOVA model to test for differences the continuous
outcome of change in patient activation and social support score with study arm
as the main independent predictor of interest. We will adjust for covariates not
balanced at baseline. If there is ceiling or floor effects with the patient activation
and social support scores we will also adjust for baseline score. For H5 we will
repeat the analysis for aim 1 including an interaction term to test difference
between arms. For H6 we will repeat the analysis for aim 1 with the main
independent variable being adherence at 6 months instead of 3 months. All

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4.3.

analyses will compare each intervention arm to the control arm and use p=.025 as
a critical value.
Qualitative survey data collected will be read and coded for cultural themes by
program specialist, and PI . Using these domains, we will conduct a descriptive
analysis of Veterans attitudes toward GlowCaps, feedback reports, and feedback
partners to improve medication adherence. This study will use a modified
Grounded Theory approach and the constant comparative method for analyzing
responses of veterans to the qualitative questions. Two members of the research
team (PI, , and program specialist) will read a random sample of 10 veteran
responses to identify and name concepts in the data, and to categorize data
according to these concepts. Through consensus, a list of coding categories and
their definitions will be developed; these codes will then be applied to all
qualitative data by the program specialist, with regular meetings of the research
team to discuss and resolve questions about codes and the application of codes
to text. Once all responses have been coded to one or more coding categories,
selective coding will be used to identify the core concept in the data and to relate
the other concepts to this central concept. A theory will then be developed
describing the relationship between concepts.

X. Privacy and Confidentiality (Privacy refers to persons and to their interest in controlling the access
of others to themselves.) (Confidentiality refers to protecting information from unauthorized disclosure
or intelligible interception.) (Investigator should contact the Privacy Officer for additional details.)
1.
Indicate the type of data that will be received by the Principal Investigator. Check all
that apply.
1.1.
De-identified – Without any identifiers that could link the data to a specific
participant. (Contact Privacy Officer for assistance. If data is coded, it is not
considered de-identified.)
1.2.
Identified – Linked to a specific participant by identifiers sufficient to identify
participants. (See HIPAA and Common Rule Criteria for list of identifiers.)
1.3.
Coded – Linked to a specific subject by a code rather than a direct identifier. If coded
is checked, specify: An amendment was submitted in August 2014 on the transfer
coded data for analysis at the VA. The data and process for coding was
discussed with CMCVAMC Privacy Officer.
1.3.1
Explain who will maintain the link or code. PI, co-PI, program specialists
1.3.2
Describe who will have access to the link or code. PI, co-PI, program
specialists
1.3.3
Provide exact details for how the data is coded. Veteran subjects will be
assigned a code number that will be used in place of his or her name on
study materials. Only the Principal Investigator, Co- Investigators, and
program specialists will have access to the key linking codes to
individual names.
2.

Does the project require the use of existing Protected Health Information (PHI) from a
database, medical records, or research records?
YES
NO
N/A
2.1.
If yes,
2.1.1. Specify the source of the existing PHI VISN 4 VA Electronic Records
2.1.2. Indicate the specific data elements/identifiers (e.g., name, address, phone
numbers, etc.) on the below table. For contact purposes and tracking:
name, address, phone numbers, date of birth, and social security
number.
For determining eligibility: diagnosis codes of CAD, pharmacy record for
medication possession ratio, and date of birth.

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2.2.

Please see the attached HIPPA waiver requesting permission to access
this data.
If the study uses an existing database/data warehouse,
2.2.1. Provide a description of the database/data warehouse. To identify potential
eligible participants we will pull names from the VISN 4 data warehouse.
2.2.2. Make clear who is responsible for maintaining it. This warehouse is
maintained by the VISN
2.2.3. Cite any relevant Standard Operating Procedures (SOP) for the database/data
warehouse. N/A
2.2.4. Provide a copy of the SOP.

3.

Will PHI be collected prior to obtaining informed consent?
YES
NO
N/A
3.1.
If yes, complete and provide a HIPAA Waiver of Individual Authorization for Disclosure
of Protected Health Information with this submission.

4.

HIPAA Identifiers - Indicate the PHI that will be collected from project participants directly or
indirectly.
4.1.
Name
4.2.
All geographic subdivisions smaller than a State, including street address, city,
county, precinct, zip code, and their equivalent geocodes, except for the initial three
digits of a zip code if, according to the current publicly available data from the Bureau of
the Census
4.3.
All elements of dates (except year) for dates directly related to an individual, and all
ages over 89 and all elements of dates (including year) indicative of such age, except
that such ages and elements may be aggregated into a single category of age 90 or
older.
4.3.1.
Birth Date
Date of Death
4.3.2.
Discharge date
Admission date
4.3.3.
Appointment Dates
Other Dates (e.g. lab tests, x-rays, MRI, etc.)
Dates GlowCaps opened
4.4.
Telephone numbers
4.5.
Fax numbers
4.6.
Electronic mail addresses
4.7.
Social Security/Medical Record Number
4.8.
Health plan beneficiary numbers
4.9.
Account Numbers
4.10.
Certificate/license numbers
4.11.
Vehicle identifiers and serial numbers, including license plate numbers
4.12.
Device identifiers and serial numbers
4.13.
Web universal resource locators (URLS)
4.14.
Internet protocol (IP) address numbers
4.15.
Biometric identifiers, including fingerprints, voiceprints, audio recordings
4.16.
Full-face photographic images and any comparable images
4.17.
Any other unique identifying number, characteristic, or code
4.18.
Personal and Family History
4.19.
History and Physical Examination
Progress Notes
4.20.
Discharge Summary(ies)
Photographs, videotapes, other images
4.21.
X-Ray
HIV (testing or infectious disease) records
4.22.
Diagnostic/Laboratory tests
Sickle cell anemia
4.23.
Drug Abuse Information
Behavioral Health notes
4.24.
Alcoholism or Alcohol Use
Operative Reports
4.25.
Billing records
Medication List
4.26.
Health Summary Reports
Anatomic Pathology Report
4.27.
Other Records:

5.

Will participants be contacted from existing PHI?

HRPP Accepted: 03/2015

YES

NO

N/A
Page 22 of 31

5.1.

6.

If yes, clearly explain how participants will be contacted (NOTE: this would be the same
information as listed under section R.8 identification and recruitment of subjects).
Potential participants once identified will first be sent a letter of introduction
letting them know about the study and giving them a number if they would like
more information or would like for us not to call them. A week after mailing out
the letter, potential participants will be called and the study will again be
introduced to them and they will be asked if they would be interested in
participating in the study. See attached letter of contact and script for discussing
the project with potential participants on the phone.

Provide the titles of the exact individuals who will have access to the collected data. The titles
of the individuals with access are Principal Investigator, Program Specialist, and
Statistician/Data Base Programmer
6.1.
Explain why these individual will have access to this data. They will have access to
identify, select, and enroll participants to be part of the study.

Y. Information Security (Contact the Information Security Officer for additional assistance regarding
confidentiality (storage/security) of research data.)
1.
Provide the precise plan how data is to be collected or acquired (repeat the same information
as listed under “Data Collection” section of this form. Once patients have consented to be in
the study and have their data managed by WTH, the WTH platform adherence tracking
information will be stored according to a unique, random, patient identifier generated for
the purposes of the study. To assure that patient, physician and other informant
confidentiality is preserved, individual identifiers (such as name and medical record
number) are stored in a single password protected system that is accessible only to
study research, analysis and IT staff. This system is hosted onsite at the University of
Pennsylvania (UPenn) and is protected by a secure identification number (ID). Any
datasets and computer files that leave the firewall will be stripped of all identifiers and
individuals will be referred to by their study ID. The study ID will also be used on all
analytical files.
The University of Pennsylvania Biomedical Informatics Consortium (BMIC) is the hub for
the hardware and database infrastructure. The data collected for Way to Health based
studies is stored in MySQL databases on a BMIC-operated blade server environment
devoted specifically to Way to Health. The data center is housed in the Information
Systems and Computing at 3401 Walnut Street. All data are stored in a single relational
database, allowing researchers to correct mistakes. Every SQL transaction, including
accessing and changing data is logged for auditing purposes. Once a participant is
consented and enrolled in the study, data are entered into the database through several
different mechanisms. A Program Specialist will manually enter subjects’ information
and enter responses to surveys through a PHP-based web interface. Researchers have
a separate interface that allows them to manually enter data if needed. This function will
be used to enter data on LDL levels. All data collection and data entry done by the
program specialists takes place at the Corporal Michael J. Crescenz VA Medical Center.
Data from monitoring devices are uploaded automatically, imported from Vitality’s webbased, password-protected platform. Vitality is the company that makes the GlowCap
electronic pill bottles. No personally identifiable information is stored in Vitality’s
platform, only subject numbers and the cap data from the electronic pill bottles. The
only data that is imported from Vitality’s platform into Way to Health are the daily
records of whether the cap was opened, which is how we will measure medication
adherence. Datasets are blinded of all personally identifiable information when exported
for analysis. The web application automatically removes all identifiers when a
researcher requests an analytic dataset. The only people with access to identifiable
participant information are pre-specified Program Specialists responsible for contacting
participants. Personal information and research data will be stored in separate SQL
tables and will be linked by a computer-generated ID number. Additionally, any
HRPP Accepted: 03/2015

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information that leaves this system to communicate with third party data sources is
stripped of any identifiers and transmitted in encrypted format. The same unique study
ID is used to link these outside data to participants. All data for this project will be
stored on the secure/firewalled servers for the BMIC Data Center, in data files that will be
protected by multiple password layers. These data servers are maintained in a guarded
facility behind several locked doors, with very limited physical access rights. They are
also cyber-protected by extensive firewalls and multiple layers of communication
encryption. Electronic access rights are carefully controlled by UPenn system
managers. We believe this multi-layer system of data security, identical to the system
protecting the University of Pennsylvania Health System medical records, greatly
minimizes the risk of loss of privacy.
For example, data will be coded and Vitality is provided only with a study ID and a “cap
ID(s)” for each participant. The Way to Health web developers have built an application
that securely and automatically transmits data from the Vitality server to the Way to
Health study server. All of the data is encrypted via https and transmitted from Vitality
to the Way to Health web application and secure Penn servers. A HIPAA Business
Associate Agreement is in place between this vender and Penn. Feedback reports are
generated within the Way to Health platform and will be mailed to participants.
CEPACT will work with the CHERP Biostatistics and Informatics Core and WTH platform
data team to develop a system to securely link limited data. The CHERP Biostatistics
and Informatics Core will extract from the VDW IRB approved patient identifiers
according to the criteria in for identifying potential participants. Identifiable data can
only accessed by the Biostatistics and Informatics Core once IRB approval for the
specific protocol has been obtained and only that data which is approved is abstracted
for the PI. The VA data available to the WTH research coordinator will include listings of
drug names and prescribing dates of related drugs and LDL laboratory information.
This VA data will be linked to the Way to Health in a similar manner as above (similar to
Vitality GlowCaps).
An amendment was submitted in August 2014 to transfer coded data from WTH server to
the CHERP biostatistics and Informatics Core for analysis. As mentioned above, the
datasets that leave the firewall will be stripped of all identifiers and individuals will be
referred to by their study ID. The study ID will also be used on all analytical files. The
data will not include and names, date of birth, date of pill bottle openings, or other PHI
identifiers. The medication adherence data will include the time stamp for the pill bottle
openings, but the time stamp will not be linked to a specific date of opening. These data
will be transferred to the CMCVAMC using a password protected and encrypted CD/DVD
as instructed by the VA ISO. On a monthly basis, this CD/DVD will be scanned by FITS
to make sure there is no malware/virus to reduce the any risk to the VA (per VA ISO
instructions). This data will be uploaded onto the secure password protected
CHERP/CEPACT server. Once the data is uploaded the encrypted CD/DVD will be stored
at Corporal Michael J. Crescenz VA Medical Center Annex, (file room 17) in a filing
cabinet on the second floor. This room is located at CHERP, which is secured by a lock
and key, and the filing cabinet containing the data will be secured by lock and key.
Subject questionnaires will be read to participants and answer will either be directly
input into a computer database or written onto paper forms and then transferred to a
database at a later time. Paper records will be stored at CHERP behind an electronically
locked entrance, a key-locked door and in a key-locked cabinet.
Lab results will be obtained from the lab or via CPRS and entered into the secure
research database

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2.

Provide a listing of the exact research data that will be stored, including but not limited to
signed, original informed consent and HIPAA authorization forms, case report forms, etc.
Adherence to statin medication, self-reported demographics, survey data examining
patient engagement in health behavior, social support, general health history, informed
consent form, and HIPPA authorization form.

3.

Indicate how project’s research data (original and all copies) will be stored and provide
corresponding security systems. Data must be used, stored, and secured according to the
requirements of the VHA series 1200 Handbooks, other applicable VA and VHA
requirements.
The data collected for Way to Health based studies is stored in MySQL databases on a
BMIC-operated blade server environment devoted specifically to Way to Health. The
data center is housed in the Information Systems and Computing at 3401 Walnut Street.
All data are stored in a single relational database, allowing researchers to correct
mistakes. Every SQL transaction, including accessing and changing data is logged for
auditing purposes. Once a participant is consented and enrolled in the study, data are
entered into the database through several different mechanisms. A Program Specialist
will manually enter subjects’ information and enter responses to surveys through a
PHP-based web interface. Researchers have a separate interface that allows them to
manually enter data if needed. This function will be used to enter data on LDL levels. All
data collection and data entry done by the program specialists takes place at the
Corporal Michael J. Crescenz VA Medical Center. Data from monitoring devices are
uploaded automatically, imported from Vitality’s web-based, password-protected
platform. Vitality is the company that makes the GlowCap electronic pill bottles. No
personally identifiable information is stored in Vitality’s platform, only subject numbers
and the cap data from the electronic pill bottles. The only data that is imported from
Vitality’s platform into Way to Health are the daily records of whether the cap was
opened, which is how we will measure medication adherence. Datasets are blinded of
all personally identifiable information when exported for analysis. The web application
automatically removes all identifiers when a researcher requests an analytic dataset.
The only people with access to identifiable participant information are pre-specified
Program Specialists responsible for contacting participants. Personal information and
research data will be stored in separate SQL tables and will be linked by a computergenerated ID number. Additionally, any information that leaves this system to
communicate with third party data sources is stripped of any identifiers and transmitted
in encrypted format. The same unique study ID is used to link these outside data to
participants. All data for this project will be stored on the secure/firewalled servers for
the BMIC Data Center, in data files that will be protected by multiple password layers.
These data servers are maintained in a guarded facility behind several locked doors,
with very limited physical access rights. They are also cyber-protected by extensive
firewalls and multiple layers of communication encryption. Electronic access rights are
carefully controlled by UPenn system managers. We believe this multi-layer system of
data security, identical to the system protecting the University of Pennsylvania Health
System medical records, greatly minimizes the risk of loss of privacy.
Hard copy-based research data will be stored at the Corporal Michael J. Crescenz VA
Medical Center Annex, (file room 17) in a filing cabinet on the second floor. This room is
located at CHERP, which is secured by a lock and key, and the filing cabinet containing
the data will be secured by lock and key. While files are actively in use, paper records
will be held in the Corporal Michael J. Crescenz VA Medical Center Annex PROMISE
(suite 200) in a key-locked filing cabinet behind an electronically locked entrance and a
key-locked door. The data will be transported between the CMCVAMC hospital and
CMCVAMC Annex in a locked case.

HRPP Accepted: 03/2015

Page 25 of 31

Project research data both original copies for hard-copies will be kept on VA property
under lock and key in filing cabinets. Electronic data will be kept secure in password
protected databases.
4.

CMCVAMC, provide exact location where research data (original and all copies) will be stored
and secured. The information for eligible subjects will be stored via: The
CHERP/CEPACT servers are located in the secure CMCVAMC server room, which is the
OI&T Server Room that has double locks and a security alarm and cameras, which is
located in Room 001 of Building 1 of the main CMCVAMC.
The filing room on the second floor of the Annex and is located at Room 17, and the
cabinet is locked inside of Room 17. Active files will be stored in a locked filing cabinet
(M133) in PROMISE, Suite 200, located on the second floor of the Annex.

5.

Explain how data is to be transported or transmitted from one location to another. No data will
be transported from one location to another. Pre-enrollment screening will take place at
the VA CHERP facilities. As stated above this information will identify patient who are
eligible for our study.
Once a patient has completed the informed consent all information will entered through
a web-based interface. This information includes all listed PHI, demographic and survey
information listed above. The GlowCaps device will be linked to study ID and
information on adherence will be collected and transmitted via wireless 3g network to
secure servers kept at University of Pennsylvania.
An amendment was submitted in August 2014, to transfer coded datasets from the WTH
to the CMCVAMC medical center. To do this, as outlined in the information security
section, the WTH Research Coordinator will download the coded data from the WTH
server onto the encrypted CD/DVD. The Program Specialist and/or PI will transfer this
CD/DVD to the CMCVAMC FITS to scan for viruses or malware. Once approved this data
will be uploaded to secure password protected CHERP/CEPACT server.
5.1.
Informed Consent discloses PHI transported or transmitted off-site. YES
NO
N/A
5.2.
HIPAA Authorization discloses entities to whom PHI will be transported or transmitted.
YES
NO
N/A
5.2.1. List all entities or individuals outside CMCVAMC to whom data is to be
disclosed, and the justification for such disclosure and the authority. University
of Pennsylvania Biomedical Informatics -- Way to Health, Vitality GlowCaps

This project requires the use of electronic medication monitoring devices that records adherence
information for the researcher and also sends reminders and adherence reports to the patient
and a designated family member/friend or peer mentor. Electronic pill bottle caps are the
preferred method among medical researchers to capture medication adherence data. In addition,
the project requires IT infrastructure to collect patient surveys via a web based interface and
integrate the survey data with medical adherence data. Due to the confidential nature of VA
patient data, the service must provide a high level of data security acceptable for government
funded medical studies.
5.3.
If yes, list the exact data that will be transmitted. Name, Home address, telephone,
DOB, Sex, Race, survey information, adherence and Medication list.
5.4.
If yes, explain how data will be protected during transmission outside of CMCVAMC.
Transfer of information will happen via use of encrypted file and log-in through a
secure server setup through the Way to Health platform
5.5.
Off-site, provide exact location The data center is housed in the Information
Systems and Computing at 3401 Walnut Street Corporal Michael J. Crescenz, PA
(If off-site, attach at least one of the following.)
5.5.1. Data Use/Transfer Agreement YES
NO
N/A
HRPP Accepted: 03/2015

Page 26 of 31

5.5.2.
5.5.3.
5.5.4.

Off-Site Storage/Transfer of Research Data YES
NO
N/A
Memorandum of Understanding YES
NO
N/A
(Note: VA data disclosed to a non-VA investigator at an academic affiliate for
research purposes needs to be approved by the Under Secretary of Health or
designee.)

6.

List who is to have access to the data and how they are to access it (anyone who has access
to the data is responsible for its security). Judith A. Long, MD who is the Principal
Investigator, the statistician and the program specialist.

7.

Describe who is to have access and be responsible for the security of the information (e.g., the
Coordinating Center, the statistician, and PI who has ultimate responsibility). Responsibility
for the information security will be maintained by the PI. Hard copy-based research data
will be stored at the Corporal Michael J. Crescenz VA Medical Center Annex, (file room)
in a filing cabinet. This room is located at CHERP, which is secured by a lock and key,
and the filing cabinet containing the data will be secured by lock and key. Paper records
that are actively in use will be held in the Corporal Michael J. Crescenz VA Medical
Center Annex PROMISE (suite 200) on the second floor, in a key-locked filing cabinet
behind an electronically locked entrance and a key-locked door.
The University of Pennsylvania Biomedical Informatics (BMIC) will be the hub for the
hardware and database infrastructure for the Way to Health Platform. All data is stored
on the secure/firewalled servers for the BMIC Data Center, in data files that will be
protected by multiple password layers. These data servers are maintained in a guarded
facility behind several locked doors, with very limited physical access rights. They are
also cyber-protected by extensive firewalls and multiple layers of communication
encryption.
Each investigator and staff member involved in the proposed study will sign and adhere
to a Standard Operating Procedure for managing participant data through the WTH
platform and has participated in required IRB/HIPAA compliance training. We will also
continue to make use of password protection programs for all computerized records. In
no instances will identifying information be publicly disclosed. Prior to conducting any
analyses, all identifiers (e.g., names, medical record numbers, health plan enrollee
numbers, birth dates, etc.) will be removed. Results from this part of the investigation
will be reported in aggregate

8.

Provide mechanisms used to account for the information. The PI will have oversight over all
information. Hard copy-based research data will be stored at the Corporal Michael J.
Crescenz VA Medical Center Annex, (file room) in a filing cabinet. This room is located at
CHERP, which is secured by a lock and key, and the filing cabinet containing the data
will be secured by lock and key. Paper records that are actively in use will be held in the
Corporal Michael J. Crescenz VA Medical Center Annex PROMISE (suite 200) on the
second floor, in a key-locked filing cabinet behind an electronically locked entrance and
a key-locked door.
University of Pennsylvania informatics system managers will carefully control electronic
access rights. They will keep log records and time-stamped information on people
accessing the data through the WTH platform

9.

Give security measures that must be in place to protect individually identifiable information if
collected or used. All identifiable information collected by hard copy paper-based data
will be kept on VA property under lock and key in the cabinet located in the locked file
room. All electronic data will have limited access, granted only to study staff, including
the principle investigator and the program specialist under supervision of the database
administrator.

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Page 27 of 31

To assure that patient, physician and other informant confidentiality is preserved,
individual identifiers (such as name and address) are stored in a single password
protected system that is accessible only to study research, analysis and IT staff. This
system is hosted on site at The University of Pennsylvania (UPenn) and is protected by
a secure firewall. Once a participant is in this system, they will be given a unique study
identification number (ID). Any datasets and computer files that leave the firewall will be
stripped of all identifiers and individuals will be referred to by their study ID. The study
ID will also be used on all analytical files.
Additionally, any information that leaves this system to communicate with third party
data sources (biometrics devices, survey software, etc.) will be stripped of any
identifiers and transmitted in encrypted format. The same unique study ID will be used
to link these outside data to the participants.
The Way to Health (WTH) Research Data Center staff is responsible for preventing
unauthorized access to the trial participant tracking system database. It is important to
note that the Way to Health database server and individual study databases have never
been compromised as a result of the extremely rigorous and secure network firewall
technologies. The secure servers are located in a specially designed, highly secured
facility at UPenn with dedicated uninterrupted power supply and strictly limited access.
The study will utilize a client-server deployed Data Management System (DMS) rather
than a 'Store and Forward' database configuration, obviating research site database
security concerns. Confidential participant information will be entered into the database.
If this information exists on paper CRFs, it will be filed under lock and key, with
generation of a participant ID. Thereafter, confidential information will be made available
to authorized users only as specifically needed. No one can gain access to an individual
MySQL database table unless explicitly granted a user ID, password, and specific
access. Even those with user names and passwords cannot gain access to the tables
that contain the identifying participant information.
No results will be reported in a personally identifiable manner. All tracking system data
will be password-protected with several levels of protection. The first will allow access
to the operating system of the computer. The second will allow access to the basic
menus of the integrated system; within certain menu options, such as database
browsing, a third password will be required. Our prior research employing similar
precautions has demonstrated that these techniques are very successful in assuring the
protection of subjects.
The same procedure used for the analysis of automated data sources to ensure
protection of patient information will be used for the survey data, in that patient
identifiers will be used only for linkage purposes or to contact patients. The study
identification number, and not other identifying information, will be used on all data
collection instruments. All study staff will be reminded to appreciate the confidential
nature of the data collected and contained in these databases.
Each investigator and staff member involved in the proposed study will sign and adhere
to a Standard Operating Procedure for managing participant data through the WTH
platform and has participated in required IRB/HIPAA compliance training. We will also
continue to make use of password protection programs for all computerized records. In
no instances will identifying information be publicly disclosed. Prior to conducting any
analyses, all identifiers (e.g., names, medical record numbers, health plan enrollee
numbers, birth dates, etc.) will be removed. Results from this part of the investigation
will be reported in aggregate.

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10.

How and to whom a suspected or confirmed loss of VA information is to be reported.
CMCVAMC Information Security Officer and Privacy Officer will be notified within one
hour of the improper use or disclosure, as well as the IRB, Associate Chief of Staff for
Research (ACOS/R) and Research Compliance Officer.

11.

Identify any circumstances that may warrant special safeguards to protect the rights and
welfare of subjects who are likely to be vulnerable including, but not limited to, those subjects
who may be susceptible to coercion or undue influence, and describe appropriate actions to
provide such safeguards. Not applicable. We will not be recruiting patients who are
considered vulnerable populations or those susceptible to coercion or undue influence.

12.

Electronic PHI will be stored on the following:
12.1. CMCVAMC desktop computer with password protection and/or encryption. YES
NO
N/A
12.1.1. If yes, identify where the desktop is located. The CMCVAMC desktops are
password protected, but not encrypted. The desktops will be located at
Corporal Michael J. Crescenz VAMC or the Corporal Michael J. Crescenz
VAMC Annex. Electronic PHI will be stored on VA servers behind the VA
fire wall and will not be removed.
12.2. CMCVAMC secure server.
YES
NO
N/A
12.2.1. If yes, identify the CMCVAMC server. VISN 4,
CMCVAMC/CHERP.CHERPNAS is a networked attached storage server
inside the VA network. It provides space to store electronic data for all
CHERP/CEPACT-related studies. It runs intel xeon 5600 series 3GHz (64
bit) CPUs with 48GB RAM and 146GB hard drive.
12.2.2. External drive that is password protected and/or encrypted.
YES
NO
N/A
12.2.2.1. If yes, identify the external drive.
12.3. Off-Site server YES
NO
N/A (If off-site, attach at least one of the following.)
12.3.1. Provide exact location and the name of the off-site server. The data stored at
University of Pennsylvania Biomedical Informatics Consortium (BMIC).
The data center is housed in the Information Systems and Computing at
3401 Walnut Street.
12.3.2. Data Use/Transfer Agreement YES
NO
N/A
12.3.3. Off-Site Storage/Transfer of Research Data YES NO N/A
12.3.4. Memorandum of Understanding YES
NO
N/A

13.

Explain how data is to be transported or transmitted from one location to another. The data
collected for Way to Health based studies is stored in MySQL databases on a BMICoperated blade server environment devoted specifically to Way to Health. The data
center is housed in the Information Systems and Computing at 3401 Walnut Street. All
data are stored in a single relational database, allowing researchers to correct mistakes.
Every SQL transaction, including accessing and changing data is logged for auditing
purposes. Data will be entered into the database through encrypted files and passwordprotected log-in into the Way to Health Platform.
An amendment was submitted in August 2014, to transfer coded datasets from the WTH
to the CMCVAMC medical center. To do this, as outlined in the information security
section, the WTH Research Coordinator will download the coded data from the WTH
server onto the encrypted CD/DVD. The Program Specialist and/or PI will transfer this
CD/DVD to the CMCVAMC FITS to scan for viruses or malware. Once approved this data
will be uploaded to secure password protected CHERP/CEPACT server.

14.

Informed Consent discloses PHI transported or transmitted off-site.

HRPP Accepted: 03/2015

YES

NO

N/A

Page 29 of 31

15.

HIPAA Authorization discloses entities to whom PHI will be transported or transmitted.
NO
N/A

YES

16.

List all entities or individuals outside CMCVAMC to whom data is to be disclosed, and the
justification for such disclosure and the authority. University of Pennsylvania _ Biomedical
Informatics, Vitality GlowCaps This project requires the use of electronic medication
monitoring devices that records adherence information for the researcher and also
sends reminders and adherence reports to the patient and a designated family
member/friend or peer mentor. Electronic pill bottle caps are the preferred method
among medical researchers to capture medication adherence data. In addition, the
project requires IT infrastructure to collect patient surveys via a web based interface and
integrate the survey data with medical adherence data. Due to the confidential nature of
VA patient data, the service must provide a high level of data security acceptable for
government funded medical studies.

17.

Clarify what protection exists for a database. Access is limited to study staff by the
database administrator
17.1. Data is stored:
17.1.1.
With identifiers - YES
NO
17.1.2.
Coded - YES
NO
17.1.3.
De-Identified YES
NO
17.1.4.
Provide the exact list of identifiers that will be stored. Name, social
security number, phone number, address, date of birth, dates of
GlowCap openings.

18.

Describe the plan for protecting research data from improper use or disclosure. Only IRB
approved study personnel will have access to study related materials. Study related
materials will be kept in password protected files on a secure server. Paper files will be
kept on the premises in locked filing cabinets.
18.1. The Investigator must notify the Information Security Officer, Privacy Officer, IRB,
Associate Chief of Staff for Research and Research Compliance Officer within one hour
of the improper use or disclosure.

19.

Is there a plan to apply for a Certificate of Confidentiality?
YES
NO
N/A
19.1. If yes, provide a copy of the certificate with this application or to the IRB Office as soon
as received.

20.

Record Retention:
20.1. The required records, including the investigator’s research records, must be retained
until disposition instructions are approved by the National Archives and Records
Administration and are published in VHA's Records Control Schedule (RCS 10-1). VHA
Handbook 1200.05 §26.h
20.2. Until a schedule for local research records is published, ALL records including
identifiers must be retained.” ORO/ORD Guidance on Informed Consent Form
Modifications Addressing VA Record Retention Requirements (July 23, 2009)
20.3. If there are additional procedures for record retention, explain further. None

Z. Qualification of the Investigators
Provide a description of the qualifications of each investigator/co-investigator and their specific
role in the study. The research conducted in this proposal will be led by Judith A. Long,
MD (Principal Investigator). She is the Chief of General Internal Medicine and Assistant
Professor of Medicine at University of Pennsylvania and Corporal Michael J. Crescenz
VA Medical Center. In addition to being core faculty at Center for Health Equity
Research and Promotion (VA CHERP) she is Associate Director of Center for Evaluation
of Patient Aligned Care Team (CEPACT). She has experience conducting primary
HRPP Accepted: 03/2015

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intervention trials at the Corporal Michael J. Crescenz VA and in the development of
peer mentor models to improve adherence to medications.
Kevin Volpp MD PhD (Co-investigator) is a general internist and Professor of Medicine at
University of Pennsylvania and Corporal Michael J. Crescenz VA Medical Center. He is
the founding Director of the Center for Health Incentives and Behavioral Economics
(CHIBE) and a core faculty member at VA CHERP.
Judd Kessler PhD (Co-investigator) is an Assistant Professor of Business Economics
and Public Policy at the Wharton School at University of Pennsylvania.
Steven Marcus PhD (Co-Investigator) is an epidemiologist, statistician, computer
scientist at the VA CHERP and Associate Professor in the School of Social Policy and
Practice at the University of Pennsylvania.
David Asch MD MBA (Co-Investigator) is a general internist and Professor of Medicine at
University of Pennsylvania, executive director of Penn Medicine Center for Health Care
Innovation, and former director of VA CHERP.

1.

If applicable, the Principal Investigator must identify a qualified clinician to be responsible for all
study related healthcare decisions. There will be no study related healthcare decisions. Dr.
Long will review all serious adverse events and determine if they are potentially study
related.

2.

PI should submit a current, dated CV with each new initial review. Please see attached CV
for Judith A. Long, MD.

HRPP Accepted: 03/2015

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