Tab 6
Eligibility Screening Form (Phase 2 Study)
“Hi, my name is _________. I’m a research staff person here at the clinic. We are conducting a research study to learn more about clinic services that might help improve patients’ attendance for medical care. I was wondering whether you might be interested in learning more about the study and possibly joining the study if you are eligible to participate. It will only take a few minutes to find out if you are eligible for the study.
“Would you like to see if you are eligible to be in our study”?
IF
YES: “Thank you.” Proceed
with Eligibility Screening Form (below).
IF
NO: “Ok. Are you willing to answer a few questions
about why you don’t want to be screened for this study?”
IF
YES. “Thank you.”
Mark
“Yes” on Q7 on the Screening Form and proceed with Q8. IF
NO. “Thank you for your time.”
Mark
“No” on Q7 on the Screening Form. You are done.
Record # ___ ___ ___ ___ Study Site __________
Date: __ __/__ __/__ __ (MM/DD/YY) Interviewer’s Initials: ___ ___ ___
Acceptance
of Screening
Patient
approached and DECLINED screening (START at Q7) Patient
approached and AGREED to screening (START at Q1)
Patient
Type New
Patient
Established
Patient
1. What is your age?
(must be at least 18 years old) |
________ age in years |
2. Are you able to read and understand English, Spanish, or Creole?
(Answer must be “Yes”) |
Yes
No |
3. Are you planning to move out of the area in the next 12 months?
(Answer must be “No”) |
Yes
No |
4. Does this patient meet all the core eligibility criteria?
- At least 18 years old - Speaks English, Spanish, or Creole - NOT planning to move out of the area in the next 12 months
|
Yes
No (If “No”, STOP here and thank the patient for their time; inform the patient they are not eligible for the study)
|
5. Is the patient willing to participate in the study, including signing informed consent?
|
Yes (Read over the informed consent form with the patient before continuing on to Q6)
No (Go to Q7 if eligible but unwilling to enroll) |
6. Participant Study ID number
(assign unique 4-digit study ID number AFTER patient signs informed consent)
The Participant study ID # begins with a 1-digit study site ID code
The last 3 digits of the participant study ID number are numbered consecutively starting with 001 for the first patient enrolled in the study (e.g. the first participant enrolled at Boston is ‘1001’, at SUNY it is ‘2001’, etc.)
|
_____ _____ _____ _____
(enter the unique 4-digit participant study ID # here once participant signs informed consent form) |
________________________________________________________________________
COMPLETE THIS SECTION FOR PATIENTS WHO DECLINE SCREENING or WHO ARE ELIGIBLE BUT DECLINE TO ENROLL (if possible)_____________
Read: We would like to better understand the reasons why patients may not want to be in this study.
7. Are you willing to answer a few questions about why you don’t want to [be screened for] OR [enroll in] this study?
|
Yes (Go to Q8)
No (Go to Q9)
|
8. Please tell me why . . . (interviewer choose one statement to complete question): a. you don't want to be screened for this study? b. you don't want to be part of this study? Note to interviewer: Check all responses most similar to reasons verbalized but DO NOT read the list of reasons to the patient.
|
I don’t have time to do it If I join the study, others might find out I am HIV+ I don’t trust research studies I don’t have reliable transportation I have young children or others to take care of so I can’t do it Someone I know might get upset if I join the study It’s not worth my time and effort I am healthy, so I do not need to be in the study I don’t feel well enough today to do it Answering survey questions is a waste of time I need to get my partner’s permission first Other reason not listed
|
9. Are you willing to tell me your sex, race, and ethnicity? |
Yes (“Thank you” - Go to Q10)
No (STOP here and thank the patient for their time)
|
10. What is your sex? (Check one) |
Female Male Transgender
|
11. Do you consider yourself to be Hispanic or Latino?
|
Yes No |
12. What is your race? (Check all that apply)
STOP here for patients who were eligible but declined to enroll -- Thank the patient
|
White Black or African-American American Indian or Alaska Native Asian Native Hawaiian or other Pacific Islander |
*** ONLY ASK THIS QUESTION OF PATIENTS WHO DECLINED SCREENING BUT AGREED TO ANSWER DEMOGRAPHIC ITEMS ***
13. What is your age?
|
________ age in years |
File Type | application/msword |
File Title | TAB 1 |
Author | Faye Malitz |
Last Modified By | HRSA |
File Modified | 2009-07-16 |
File Created | 2009-06-30 |