Justification for changes to 2 forms at Philadelphia site

Change Request

Cooperative Re-Engagement Controlled Trial (CoRECT), OMB No. 0920-1133

February 9, 2017

Overview

The CoRECT study is a randomized controlled trial being conducted by the Massachusetts State Department of Public Health, the Connecticut State Department of Health, and the Philadelphia Department of Public Health. Each site will enroll approximately 300 study participants. The CoRECT study seeks to 1) establish a data-sharing partnership between each health department and collaborating HIV care clinical providers, 2) accelerate the identification of HIV-infected persons who are out of care, 3) successfully re-engage these individuals in HIV medical care, and 4) evaluate three site-specific models of enhanced data linkage and re-engagement in care. Each jurisdiction is implementing an active health department field services intervention that has been tailored to its operating environment.

Minor changes are proposed to two forms in use at the Philadelphia site. Philadelphia elicited feedback from the medical providers who would be completing the Barriers to Care and Standard of Care surveys. After receiving their input, Philadelphia made a few changes to improve the surveys’ ease of use. The proposed changes will not result in any additional burden to the respondents or grantees in the CoRECT study.

• Attachment 7: Barriers to Care Survey (Philadelphia). This is a one-time domain assessment that Disease Intervention Specialists (DIS) use to determine barriers and challenges that prevent participants from seeking HIV care. This Change Request seeks to add two domain categories, allowing the DIS conducting the survey more comprehensive options to discuss when identifying the participant’s barriers to remaining in or linking to HIV care.

• Attachment 10: Standard of Care Survey (Philadelphia). This is a self-administered survey of project clinical providers conducted at multiple time points throughout the study period. The proposed changes will decrease the length of the survey by omitting four questions that had been asked in prior data tools for the CoRECT study, thus removing the questions prevents redundancy. Five questions will be added to assess the study’s patriating healthcare provider’s capacity to conduct the activities for the CoRECT study.

Detailed Discussion of Nonmaterial/non-substantive changes to Attachment 10

1. The change in the wording of the questions on the “Standard of Care Survey” will result in clearer, more specific questions for the HIV providers.

2. Five questions were added to Philadelphia’s Standard of Care survey to collect information on the HIV provider’s capacity to identify their patient population who have disengaged HIV care.

3. Four questions were removed from the Standard of Care survey to prevent duplication.

4. The format for Attachment 10 was modified to improve usability and fit in a document. The form will be administered electronically.

Current Question/Item	Requested Change
4) What administrative support staff are employed at your facility? (Please check all that apply.) -Other (please specify) -Office Manager -Medical Billing Staff -Scheduling Staff -None of these	4) Please indicate how many administrative support staff you have at your facility. Number of staff Total amount of FTE to the nearest tenth -Office Manager -Medical Billing Staff -Scheduling Staff
Added Question	6) If any new positions have been added to your practice please indicate them below. If there have been no new positions added please enter "no changes" in the box below.
Added questions	12) Please indicate what changes have occurred at your practice since the last time you took this survey.
13) In the last year, what methods has your practice used to re-link HIV patients back to care? (Please check all that apply.) -Other (please specify) -Called the patient after a missed medical office visit -Made a field visit to the patient after a missed medical office visit -Sent letters to the patient after a missed medical visit -Sent the patient a text message -Sent the patient a message via -your health system’s secure patient portal	13) In the last six months, what methods has your practice used to re-link HIV patients back to care? (Please check all that apply.) -Called the patient after a missed medical office visit -Made a field visit to the patient after a missed medical office visit -Sent letters to the patient after a missed medical visit -Sent the patient a text message -Sent the patient a message via your health system’s secure patient portal Other____________
16) Briefly describe your facility's protocol for re-linking HIV patients who have been lost to care?	15) Briefly describe your facility's protocol for re-linking HIV patients to care. If it is too long to describe below, please send it separately. If nothing has changed since your last survey please indicate no change in the box below.
19) How often is your facility's protocol for re-linkage practices modified? -Other (please specify) -Never -Every 3-6 mos -Every 6-12 mos -Every 1-2 yrs	17) How often is your facility's protocol for re-linkage to care reviewed? - twice a year -once a year -every 1-2 years -never -Other
22) What other computerized systems do you use to collect data on your patients? (Please check all that apply.)	18) Are any of your computer or data systems currently undergoing replacement, upgrades or Development?
Added Question	19) Are any of your computer or data systems scheduled to undergo replacement, upgrades or development?
Added Question	20) If your facility has incurred any new costs as a result of participating in the CoRECT project please describe them below.
Added Question	21) Do you have any concerns about participating in CoRECT that you'd like to share with us?
Question Removed	14) Which staff at your facility contact HIV patients when you are attempting to re-link them to care?
Question Removed	12) How frequently do patients report the following issues as a barrier to staying in treatment for their HIV?
Question Removed	11) How frequently do patients report the following issues as a barrier to initially linking to treatment for their HIV?

Detailed Discussion of Nonmaterial/non-Substantive changes to Attachment 7

1. There was a change to the number of barrier domains that will be utilized to identify the patients barriers to remaining linked to care. In an effort to capture more possible barriers to care “Other” was added to each domain to allow the DIS to describe barriers not previously identified in this assessment. In addition to adding the “other” option to each domain, three other domains were added: Patient education, Utilities, and Communication with service system. Adding theses domains will allow the DIS additional areas to identify barriers to care.

2. There were four other categories added to the assessment which will allow the DIS to prioritize the barrier identified and indicate who identified the barrier. The assessment was modified to provide the DIS with ability to prioritize the barrier identified as “Primary” or “Secondary”. Because the “Patient Barrier Assessment” will be administered in a qualitative format the DIS will indicate who identified the barrier. The DIS will indicate the status of the barrier identified by selecting whether the barrier identified was resolved, not resolved or pending.

3. The “Intervention Phase” was added to the “Patient Barrier Assessment” to enable the DIS to indicate the phase the study participants are engaging in the ARTAS intervention. The intervention phase categories are Care Engagement, Transition to Care or Both.

Current Question/Domains	Requested Change
1) Attitudes/ Perceptions about HIV and Health My CD4 count and viral load are good There is no cure for HIV so I don’t need to go to the dr.	A)Attitude / Perception about HIV and Health 4) CD4 count and viral load are good 5) Didn’t think I am HIV positive 3) Since there is no cure for HIV, why should I go to my doctor
2)Challenges with Medical Facility + Added question	B) Challenges with Medical Facility 16) + Other_________
3)Challenge with Medical Provider I didn’t like the way that I was treated at the clinic in the past + Added question	P) Challenge with Medical Provider My doctor is not addressing my needs 50) +Other_____________
4) Time Management and Organization + Added question	H) Time Management and Organization 34) +Other_________
5)Health Insurance and access to Medical Care + Added question	G) Health Insurance and access to Medical Care 29 + Other______________
6)Childcare + Added question	I) Childcare 36)+Other___________
7) Housing + Added question	N) Housing 45) + Other
8) Transportation + Added question	J) Transportation 38) +Other
9) Financial Challenges I can’t Pat my bills	T) Financial Challenges 57)Intermittent public assistance 58)+Other _____________
10) Food Security I don’t have any food +Added question	S) Food Security 55) I don’t have enough food 56) +Other____________ F) Unemployment 24) +Other___________
11) Unemployment +Added question
12) Incarceration +Added question	O) Incarceration 48) +Other___________
13) Religious Objection +Added question	M) Religious Objection 44) +Other___________
14) Disclosure/Privacy +Added question	L) Disclosure/Privacy 42) +Other___________
15) Stigma +Added question	E) Stigma 22) +Other___________
16) Medication Adherence +Added question	D) Medication Adherence 20) +Other___________
17) Mental Health +Added question	C) Mental Health 18) +Other___________
18) Substance Use +Added question	K. Substance Use 40) +Other___________
+Added Domains/Barriers	Q) Patient Education 51) +Lack of understanding of HIV disease 52) +Other_____________ U) Utilities 59) Can’t Pay my utilities 60) +Other______________ V) Communication with service systems 61) +No TTY 62) +Language Barrier 63 +Other________________
Patients Assessment Categories	Patient Barrier Assessment Barrier Priority ( ) Primary ( ) Secondary Barrier identified by: ( ) Pt ( ) DIS ( ) Both Barrier Status ( ) Resolved ( ) Not Resolved ( ) Pending Intervention Phase ( ) Care Engagement ( ) Transition to Care ( ) Both

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