Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Sponsor: VA Office of Research and Development

Title: Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control (CEPACT) 
NCT Number: NCT01651117 
Date of Document: Approved 01/13/2016 

Human Studies Subcommittee (IRBII)
Department ofVeterans Affairs Medical Center
Research and Development Service
3900 Woodland Avenue • Philadelphia, PA 19104 • 215-823-3003 • Fax:215-823-5171
IRB APPROVAL - Amendment
Date: January 13, 2016
From:
Terri M. Laufer, MD, Vice Chairperson
Investigator: Judith A. Long, M.D.
Protocol: Using Peer Mentors to Support PACT Team Efforts to ImproveDiabetes Control (CEPACT)
ID:
01373
Prom#: 0013
Protocol*: N/A
The following items were reviewed and approved through Expedited Review:
•
Amendment - Expand enrollment by 115 - 69 poorly controlled diabetic veterans and 46mentors
(12/11/2015)
Expedited Approval [Expedited under Federal Regulation: 45 CFR 46.110(b)(2) /VA Regulation: 38
CFR 16.110(b)(2)] was granted on01/13/2016. This Expedited review will bereported to the fully
convened Human Studies Subcommittee (IRB II) on 01/20/2016.
The following othercommittee reviewsare scheduled:
Research & Development Committee [02/02/2016]
The Corporal Michael J. Crescenz VAMC IRB is not connected with, has no authority over, and is not responsible for human
research conducted at any other institution, except where aMemorandum ofUnderstanding specifies otherwise. Separate consent
forms, initial reviews, continuing reviews, amendments, and reporting ofserious adverse events are required ifthe same study is
conducted atmultiple institutions.
.^—_^-^^———^—————•——

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CMCVAMC Specific Protocol Summary
Content Requirements for IRB Committee
Review
CMCVAMC IRB
CMC VA Medical Center Institutional Review
Board
A.
Protocol Title
1.
Full Protocol Title: Using Peer Mentorsto Support PACT Team Efforts to Improve Diabetes
Control (CEPACT)
2.
Date of Protocol Summary and Version #: Date 12/15/2015; Version # 7
B. Principal Investigator's Full Name and Degree: Judith A. Long, MD
APPR0VE°t>vCMcw»^
C. Co-Investigator's Full Name and Degree:
/l^/lb
D. Financial Sponsor (Provide the name ofthe agency, organization, companyor person providing
funds for the research study.) HSR&D
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.) N/A
G. Institution(s) responsible for the project:
1.
For single-site studies - CMCVAMC isthe only institution involved. Yes XNo D
2.
For multi-center studies.
2.1. CMCVAMC isthe Coordinating Center in which the PI isthe lead investigator. Yes •
No
•
n/aD
2.2. Provide the name ofthe 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.
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 forthis project. Asummary ofthe relevant literature in the area of interestand reports of
previous studies should be included.)
Peer support and particularly mentors have been shown to helpAfrican American diabetic veterans
with poordiabetes control improve theirglucose control. Ongoing studies are testing whether
mentors can help non-veterans and populations including a largersample size ofwomen. Peer
mentors may be particularly effective in a VA setting where many patientslacksocial supportand a
culture of camaraderie is strong. However, it is unknown if improvements persist once mentoring
stops, how to best sustain such programs and whether peer support models would be effective in
veterans from all ethnic racial groups.
Purpose of the Project: (Clearly provide the purpose ofthis research project.)
In this study, we propose a randomized controlled trial ofpoorly controlled diabetic veterans in which
poorly controlled veterans of all race/ethnicities first enroll as mentees in a program for diabetic veterans
and then as mentors to test a model of sustainability. In addition, given a growing literature that being a
mentor isgood for your health besides from creating sustainability for the program it may help sustain
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effects. This study will have 4 arms: 1. Usual care (enrolled attwo different time points); 2. Peer
mentoring where mentors are veterans who were once in poor control but are now in good control; 3.
Peer mentoring where the mentoring comes from former mentees from arm 2 (mentoring FFM); and 4.
Former mentees from arm 2 not randomized to becoming a mentor. Ultimately we aim to create
programs that can serve to sustainably support VA Patient Aligned Care Team (PACT) efforts.
Describe the Research Questions or Hypotheses (that is, what questions are you trying to address by
conducting the research.)
Our primary aims are as follows.
1. Test the effectiveness of a peermentor model in a mixed race population of poorly controlled diabetic
veterans.
H1: Compared to usual care, veterans in the peer mentor arms will have improved hemoglobin
(HbA1c), blood pressure, LDL levels, DM quality of life, and depression scores regardless of race or
ethnicity atthe end of the intervention (tested at6 months) and effects will persist (tested at12 and
18 months).
2. Test the effectiveness of using former peer mentees as peer mentors.
H2: Compared to usual care, veteran who receive peer mentoring from former mentees will have
improved hemoglobin (HbA1c), blood pressure, LDL levels, DM quality of life, and depression scores
at the end ofthe intervention (tested at 6 months) and effects will persist(tested at 12 and 18
months).
3. Assess the effects of becoming a mentor on those who were originally mentees.
H3: Compared to pastmentees who are not randomized to becoming a mentor, pastmentees
randomized to becoming a mentor will have better glucose control, blood pressure, LDL levels, DM
quality of life, and depression scores.
4. Conduct a rigorous qualitative evaluation examining in-depth the mentor-mentee relationship, the
transition to becoming a mentor, qualities of a successful mentor, and factors relevant to broader
program implementation.
Secondary Aims:
5.
In those randomized to being a mentee, explore mentor characteristics associated with improved
HbA1c. Predictors to beevaluated include pastmentoring doseof thecurrent mentor, thementor's
past change in HbA1c, the mentor's starting HbA1c, current mentoring dose provided by the mentor,
mentee's evaluation of the mentor, and mentor's depression score at baseline.
I.
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 Ais superior to treatment Bin the treatment
of subjects with essential hypertension, the primary outcome variable is blood pressure
measurement.)
The primary outcome variable will be change in glucose control asmeasured by the HbA1cassessed
at baseline, 6 months,12 months and 18 months.
J.
Secondary Outcome Variable(s): (Define the secondary outcome variables. Such measured
variables should also include the timing of measurement.)
Secondary outcome variables will include blood pressure, serum LDL, diabetes quality of life
measured by the self reported Diabetes Distress Scale, and depression assessed with the PRIME-
MD Patient Health Questionnaire (PHQ-9). All secondary outcomes will also be measured at
baseline, 6 months and 12 months.
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K. Study Design and Methods:
1.
Is this a clinical trial?
XYES
QNO
1.1.
If yes, what type? Check all that apply.
•
Phase I
•
Phase II
XPhase III
•
Phase IV
1.2.
If yes, this study must be registered on Clinicaltrials.gov.
Design
2.1.
What research me
XSurveys/Questionnaires
•
Behavioral Observations
D Focus Groups
XControl Group
XSpecimen Collection
D Other (Describe)
hods will be used in the project? Check all that apply
X Interviews
D Chart Reviews
X Randomization
Placebo
D Deception
Audio Taping
D Video Taping
D Double-Blind
D Withhold/Delay Treatment
X Telephone Survey
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. Randomization will be a staged process (see figure 1). For both steps,
randomization will be conducted by the studystatistician using a random number generator and
via permuted block randomization with variable block sizetoforce balance among treatment
groupassignments afterevery block of participants is enrolled.
At stage 1, interested participants will be randomized to usual care orpeer mentoring. At stage 2,
interested participants will be randomized to usual care or peer mentoring from a former mentee
(FFM). In addition, former mentees with be randomized to either becoming a mentor orusual care
(i.e. mentee assigned or no mentee assigned).
To date we have been randomizing patients in a 1:1 manner. After receiving IRB approval forthis
modification we will change to 2:1 randomization (2 to an intervention armfor every 1 enrolled
into usual care). See below for exact numbers.
Figure 1 Randomization
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Stage 2
Randomization
Peer
Mentoring FFM
Usual Care
2.3.
For retrospective research studies, provide the"look-back" period, (e.g., December 1,
1999 through December 31, 2008.)
Study Duration
3.1.
Provide the estimated length oftime to enroll all subjects and complete the study.
Wewant to enroll a total of492 poorly controlled diabetic veterans and 206 mentors with currently
good glucose control. In stage 1there will be206 poorly controlled diabetics in the peer
mentoring arm and 206 mentors. Mentors who withdraw from thestudy will be replaced by
additional mentors to ensure that all 206 poorly controlled diabetics in the peer-mentoring arm
have mentors. In stage two there will be 144 mentors (former mentees) of which 72will be
randomized to being a mentor and 72 will be randomized to usual care. In addition, there will be
128 poor controlled diabetics 56 of whom will be in usual care and 72 of whom will be randomized
to receiving peer mentoring from FFM. We project being able to enroll 7-8 new poorly controlled
diabetics per week with two research assistants. Even considering thestaggered start times, we
anticipate it will take 14-16 months to complete enrollment and another 18-24 months to complete
follow-up for a total of 38-40 months. After that we anticipate it will take an additional 1-2 months
to complete the analysis. Seesample size section for further description of required sample.
3.2.
Explain the expected duration ofsubject participation including any follow-up.
The active time for each participant in the study will be roughly 18-24 months depending
onwhich arm they are randomized to. 12-18 months offace-to face visits with an
additional 6 months after the last in-person visit where each participant's electronic
medical record (EMR) will be under electronic review. Figure 2 depicts theflow of
participants through the study.
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ARMl
Stage 1
Randomization
Figure 2: Flow of Participants Through Study
Stage 1
Mentors
J
••.
6 Months:
••,
••
Assessment
••
12 Months:
Assessment
Usual Care
Baseline
^0
6Months:
H
MM
Assessment
MM
12 Months:
Assessment
ARM 4 ^H
No Mentee
^J
^K
Assigned
__
12 Months:
Assessment
Mentees
Baseline
ft_J
Mentee
^|
^H
Assigned
••
12 Months:
Assessment
ARM 2
ARM 3 ^H
Mentoring FFM
WM
HK
Baseline
H||
6 Months:
Assessment
Stage2
1
Randomization
iIk
Usual Care
m
•VI
Baseline
••§
r
6 Months:
Assessment
ARMl
18 Months:
EMR
18 Months:
EMR
18 Months:
Assessment
18 Months:
Assessment
12 Months:
Assessment
12 Months:
Assessment
24 Months:
EMR
24 Months:
EMR
18 Months:
EMR
18 Months:
EMR
3.3.
Specify the projected date of completion of the proposed study.
Enrollment started September 27, 2012 and we anticipate completion ofthe study by
December 31, 2015
4.
Drug Information (If not applicable state, "Not Applicable.") N/A
4.1.
Specify ifthe 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) numberfor all non-FDA approved and
off-label drugs, biological agents or nutritional supplements. If notapplicable state, "Not
Applicable."
4.3.
Provide all relevant information about the drug
4.4.
Explain anywash-out periods, rescue medications permitted and anytypeof
medications not permitted while enrolled in the study.
4.5.
Describe blinding and un-blinding procedures.
4.6.
Include the dosage, route ofadministration, previous use, and the safetyand 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.
Describe where drug preparation will be done.
4.10.
All drugs for CMCVAMC subjects must be dispensed through the VA investigational
pharmacy.
4.11.
Describe where the study treatment will be administered.
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4.12.
Describe planfortracking a non-compliant treatment study subject.
4.13.
Summarize any pre-clinical data.
4.14.
Describe the process for the storage, security, dispensing and return ofan
investigational drug.
5.
Investigational Device (If not applicable state, "Not Applicable.") N/A
5.1.
The Investigational Device Exemption (IDE) number must be submitted for all significant
risk devices and ifan IDE exists for a non-significant device.
5.2.
Significant Risk or Non-significant Risk - If a device is notapproved by the FDA, specify
whether or not the sponsor has determined this device to be a "significant risk" or "non
significant 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 ifdevice 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 bythe 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 planfor 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.
L.
Does this projectinvolve international research? DYES XNO
1.
For further instructionsrefer to VHA Directive 2005-050. Requirements for Conducting VA-
Approved 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 atinternational sites (not within the United States(U.S.), its
territories, or Commonwealths); any VA-approved research using eitherhuman biological
specimens (identified, de-identified, orcoded) orhuman data (identified, de-identified, or
coded) originating from international sites; orany VA-approved research sending such
specimens ordata out ofthe U.S. (see par. 56). NOTE: For the purposes ofthis Handbook,
research conducted at U.S. military bases, ships, orembassies is notconsidered international
research.
M. Study Procedure
1.
Study Procedures
1.1.
Outline all study procedures - (If necessary, include a table orflow chart, showing the
schedule of theprocedures andinteractions. Distinguish between interventions that are
experimental andcarried out for research purposes vs. thosethat are considered
standard of care. Routine proceduresthat areperformed solely for researchpurposes
should also be identified.)
Overview: We will perform a randomized controlled trial with four arms. The aim is to create a
program that can augment PACT efforts.
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Patients and Settings: We will enroll veterans with diabetes mellitus (DM)who receive their care
from the CMC VA Medical Center (CMCVAMC). Veterans between the ages of 30 and 75 years
of age - patients most likely to reap the benefits of gaining control - will be eligible for
participation. There will be 4 arms: 1. Usual care (enrolled at two differenttime points); 2. Peer
mentoring where mentors are veterans who were once in poor control but are now in good
control; 3. Peer mentoring where the mentoring comes from former mentees from arm 2
(mentoring FFM); and 4. Former mentees from arm 2 not randomized to becoming a mentor. To
ensure that we are targeting those most likely to benefit from improving control we enroll diabetics
with persistently poor DM control. Persistently poor DM control will be defined as having an
HbA1c > 8% on 2 different occasions in the course of 24 months, with at least 1 measure within 3
months of enrollment. Mentors for arm 2 will have previously been in poor control and are now in
good control, defined as having an HbA1c of > 8% inthe past 3 years and an HbA1c < 7.5%
within 3 months of enrollment. They will also, when feasible, be the same race, sex, and age (±
10 years) as their mentee. When possible, ifthe mentee is on insulin we will seek out a mentor
on insulin. These criteria for selecting both mentees and mentors have led to successful
mentoring partnerships in our priorwork. Patients 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 from the VDW on an ongoing basis. The VDW
is updated regularly and thus an excellent source of up-to-date patient information. Identified
patients will be sent a letter describing the study and then called. The PI has used this method to
identify veterans with DM on many occasions and routinely is able enroll between 60-70% of
those contacted. Potential mentors for arm 2 will be identified and approached in a similar
manner. Veterans who agree to participate will be invited into the CMC VAMC to complete a
consent procedure, baseline survey, and have their blood drawn to determine their HbA1c at
enrollment. All enrollees and mentors will receive, regardless of the arm, $50.00 for each visit
requiring a blood draw and survey completion (baseline, 6 months, 12 months, and depending on
arm, potentially 18 months).
At the end of 6 months, those randomized to receiving a mentor in stage 1 will be re-randomized
to either becoming a mentor (arm 2) or not becoming a mentor (arm 4). Those who do not
become a mentor will continue to be followed. Those randomized to being a mentor will become
mentors for arm 3 participants. For arm 3, matching will be tailored to the best of our ability since
the pool of mentors will be limited to those who were previously mentees. We have built in over-
enrollment into stage 1 to allow for some loss to follow-up and selective removal of participants
who might be inappropriate mentors. Potential mentees for stage 2 will be identified and
contacted in the same manner as those identified for stage 1. Those interested in participating
will be randomized to usual care or mentoring from FFM. As with stage 1, participants will receive
$50 to reimburse them for their time for all required in person visits.
Procedures: As mentioned there will be 4 arms. Randomization into each arm is described above.
Arm 1 Usual Care: They will complete all planned surveys, interviews and blood draws (baseline,
6 months, 12 months). In addition, all participants' medical health record will be under electronic
review for an additional 6 months after their last visit. They will be notified of their starting HbA1c
and the American Diabetes Association (ADA) and VA recommended goals for HbA1c. No
additional interventions will be provided. All participants will be called at one month and three
months to check in and assess for hypoglycemic events (based on our past previous work we
anticipate that these events will be rare and not differ by arm).
Arm 2 Peer Mentoring: In addition to being notified of their starting HbA1c and ADA and VA
recommendations for HbA1c, arm 2 will be told that within the next 1-3 weeks we will find them a
peer mentor whowill start calling them. Theywill be told that they are expected to talk with the
mentor at least once a week for 6 months but they can talk as much as they want. We will also
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explain that we will not be setting up a face-to-face introduction butthat it isfine for the two of
them to meet in person if they desire. Finally, participantswill be reminded that insix months
time they may become a mentor. We will train them to be mentors and provide them with a
mentee who is in poor diabetes control.
After being randomized to the peer mentor arm we will identify potential mentors and contact
people until an eligible mentor is found. Mentors will participate in an hour long one-on-one
training informed by motivational interviewing techniques. All training materials have been
developed and include instruction on learningthe mentee's story, understanding the mentee's
motivations, helping the mentee identify the differences between their behaviors and goals, and
helping the mentee identify a realistic plan for goal achievement. Open ended questions are
encouraged and modeled. Mentors are also taught how to follow-up and assess progress.
Sample questions will be provided. However, mentors are also encouraged to draw on their own
experiences. Once a month, peer mentors will be contacted to provide training reinforcement and
asked about their interactions with their mentee. Peer mentors will be given the phone number of
their mentee and informed that they will receive $20 per month for speaking at least once a week.
Whether they spoke will be determined by self-report.
At the end of 6 months, at the first follow-up visit mentees will be randomly assigned to become a
mentor or to not become a mentor. Those selected to become a mentor will be trained how to be
mentors and told that we will contact them in the next 1-3 weeks with a mentee. They willthen be
asked to perform all of the activities that their mentor performed for them. Like their mentors, they
will also receive $20 per month for talking at least once a week.
Arm 3 Peer Mentoring FFM: As with the other arms the participants will be notified of their starting
HbA1c and ADA and VA recommendations for HbA1c. To the best of our ability, Arm 3 will be
matched with a mentor race, sex, age (± 10 years), and insulin use. The mentor will come from
Arm 2 and initiate phone contact.
Arm 4 Former Mentees not Randomized to Becoming a Mentor: Arm 2 participants not
randomized to becoming a mentor will be followed inthe same manner as arm 2 participants
randomized to becoming a mentor.
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Data Collection: All participants (mentors and mentees) will complete a baseline survey, a short
call at 1 and 3 months, a 6 month survey, a 12 month survey, a blood draw at baseline, 6 months,
and 12 months and will have their medical health record under electronic review for an additional
6 months after the last in-person visit. Those randomized to arm 2 and further randomized to arm
4 will receive additional short calls at 7 months and 9 months and have one additional in person
visit with blood draw at 18 months. A sample of mentors and mentees from stage 1 and stage 2
will be asked to complete qualitative interviews baseline, 6, 12, 18 months. Table 1 identifies data
to be collected at each time point and the source of the data.
Table 1: Measurement Schedule
Baseline
1
M
3
M
6
M
12
M
18
M
24
M
Dependent Variables
HbAic (blood)
X
X
X
X
Blood Pressure (in person measurement)
X
X
X
X
Direct LDL (blood)
X
X
X
X
DM quality of Life (self-report) - Distress
X
X
X
X
Depression Symptoms (self-report) - Mood
X
X
X
X
Intervening Variables of Interest
Social Support
X
X
X
X
Self-Efficacy (self-report)
X
X
X
X
Perceived Benefits and Barriers (self-report)
X
X
X
X
Self-management Behaviors (self-report)
X
X
X
X
Past Mentoring Dose Received by Current Mentor (Past records)
X
Mentor's past Change in HbAic(Past study records)
X
Mentee's assessment of mentor quality (self-report)
X
X
X
Potential Confounders
Demographics (self-report)
X
Attachment Style (self-report)
X
Perceived Need for Support (self-report)
X
X
X
X
BMI (in person measurement)
X
X
X
X
DM Health History (self-report)
X
General Health History (self-report)
X
X
X
X
Potential Contamination (self-report)
X
X
X
Hypoglycemic Symptoms (self-report)
X
X
X
X
X
X
Qualitative Perceptions of Program (self-report)
X
X
X
X
Medical Record Review (Electronic medical record)**
X
X
*
CurrentMentoring DoseProvided by Mentorwillbe assessed monthly. For Easeof Presentation we did not include all
collection times.
** Exact timing of EMR review depends on arm - only reviewed once either at 18 or 24 months.
For self-reported data we will use validated survey questions developed by the PI or other
researchers in the field. The research coordinator will be trained to measure BP and pulse rate at
each visit using an automatic digital blood pressure monitoron the non-dominant arm after the
subject has been seated for 5 minutes. An average of two measurements will be used for
analyses. We will evaluate both change in systolic and diastolic BP as well as the percent of
patients in each arm withADA target BP (BP < 130/80 mmHG). Height and weight will be
measured using standard procedures with a beam balance and a strain-gauge digital scale,
respectively, and used to calculate body mass index (BMI).
We will conduct the qualitative interviews with the aim of understanding how, in terms of the
outcome HbA1c, successful mentor-mentee pairs differed from those who were not successful.
Interview guides will be informed byadult learning theory. We will use semi-structured interviews.
Open-ended questions will be followed by probes to promptdetail and ensure that a broad range
of possible responses are elicited. Using constant comparison techniques, we will modify scripts
in real time as new and unexpected themes emerge.
1.2.
Explain ifand how the follow-up of subjects will occur.
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Follow-up will occur at 1 and 3 months post enrollment with a brief phone call, and at 6 months
and 12 months post enrollment at the CMC VA Medical Center. Additional short calls at 7 and 9
months and an additional in person 18 month visit will also occur for those in arm 2 and 4. After
follow-up in person visits are complete, all enrolled participants' medical health record will be
under electronic review for an additional 6 months.
1.3.
Describe where, how and who will be conducting study procedures.
Consent, study surveys and interviews, blood pressure measurements, and weight at baseline, 6
months, 12 months and when appropriate 18 months will occur at the CMC VA Medical Center
and be performed by a project manager or research assistant.
One and three month hypoglycemic assessments will be assessed over the phone by a project
manager or research assistant.
Evaluations of the serum HbA1c and LDL will be performed by the CMC VA Medical Center lab.
Electronic review of medical health records will occur at the CMC VA Medical Center on the VA
server network.
1.4.
Ifa survey study, specify the estimated amount of time that subjects will need to
complete the questionnaires/tools.
The below table estimates the amount of time each step will require for data collection. The
amount of time spent on mentoring calls is not determined by the study.
Table 2: Data Collection Step, Time to Complete and Mode of Collection
Procedure
Estimated Time to
Complete
Number of Times to
Perform
Consent
30 minutes
1 (in person)
Baseline Survey
45 minutes
1 (in person)
Lab tests
10 minutes
3-4 (in person)
Hypoglycemic Symptoms
5 minutes
2 (phone call)
Follow-up Survey
30 minutes
2-3 (in person)
Qualitative Interviews
20 minutes
2-3 (in person)
Health record review
15 minutes
1 (electronically)
Mentor Training
60 minutes
1 (in person)
Reinforcement Calls
10-15 minutes
5 (phone call)
Estimated Total Active Time for Participants
Arm 1
175 minutes (= 3.0 hours)
Arm 2
385 minutes (= 6.5 hours)
Arm 3
215 minutes (= 3.5 hours)
Arm 4
385 minutes (« 6.5 hours)
Mentors for Arm 2
325 minutes (= 5.5 hours)
Based on experience, consent will take about 30 minutes and the baseline survey will take
approximately 45 minutes. Follow-up visits will take about 30 minutesforsurvey completion and
20 minutes for the completion of qualitative interviews. The lab usually expedites tests for
research and we expect patients will need to spend approximately 10 minutes getting their blood
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drawn. The total time commitment for consent and data collection is estimated to be between 3
and 7 hours depending on the arm the person is in. However, given the time commitment we will
reimburse participants $50 for each in person visit to cover time and transportation costs and an
additional $40 for qualitative interviews ifthey agree to complete the qualitative interview portion
of the study.
1.5.
If a blood draw, specifythe 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 CMC VAMC lab. We anticipate a maximum of 5ccs or 1 teaspoon of
blood will be required for each in-person visit at baseline, 6 months, 12 months and when appropriate
18 months..
2.
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 survey, interviewand lab tests. In addition, mentors
will receive short reinforcement calls each month at which time we will collect data about how
many times the mentor talked to the mentee inthe month. Hypoglycemic symptoms will be
assessed by phone at 1 and 3 months (additionally at 7 and 9 months for arms 2 and 4).
Electronic medical records will be reviewed 6 months after the last in person visit. See Table 1
and 2 for details.
2.1.2.
the precise plan for how data is to be collected or acquired
Surveys will be read to participantsand answers will either be directly input into a computer
database or written onto paper forms and then transferred to a data base at a later time. The
data base will reside on VA servers behind the VA firewall and will never be removed from the
server. Paper records will be stored at CHERP behind an electronically locked entrance, a key-
locked door and in a key-locked cabinet.
Qualitative interviews will also be read to participants and answers will be voice recorded.
Interview data will be stored on the VA server and will be behind VA firewalls This data will be
temporarily shared with Alpha Transcription, and University of Pennsylvania's Mixed Methods
Research Lab, transcribing and coding respectively. Both companies are approved vendors with
appropriate VA approved data security in place.
Data about the number of calls per month made by the mentor will be collected over the phone,
and again responses will eitherbe entered directly into a database orfirst onto paper and then
into the database.
Data about hypoglycemic symptoms will be collected overthe phone and responses will either be
entered directly into a database or first onto paper and then onto the database.
Lab results will be obtained from the lab or via CPRS and entered into the secure research
database.
Charts will be abstracted for additional HbA1c, LDL, and blood pressure readings 6 months after
the last face-to-face visit.
2.1.3.
exact location where data will be collected,
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CMC VAMC and the CMCVAMC Annex (for in person, phone and chart derived data).
2.1.4.
exact location where data entry will take place.
All data entry will occur either at the CMC VAMC or the CMC VAMC Annex. Paper files for the
study will be housed at the CMC VAMC annex in locked filing cabinets. Data will be stored on VA
servers behind the VA fire wall. .
2.1.5.
the "title" of individual(s) collecting the data and analyzing the data, e.g.
principal investigator, research coordinator.
A Project manager and/or research coordinators will be collecting data and entering it intothe
database. The Principal investigator and a master's level programmer will be analyzing the data.
Identifiable data will not be removed from CMC VAMC servers. Access to identifiable data will be
limited to those who require access including the project manager and research coordinators,
principal investigator, and the programmer.
2.2.
Provide a time line for each aspect of the study.
Baseline: Obtain consent, complete baseline survey, randomize, obtain blood.
For arm 2 (and 4) also: Identify mentor, obtain consent from mentor, complete mentor baseline
survey, train mentor, obtain blood from mentor, have mentor start calling mentee.
6 months: Complete follow up survey, interviews, and blood for mentors and mentees.
For arm 2 also: Train arm 2 participants to be mentors and match them to mentees (participants
in arm 3).
12 months: Complete follow up survey, interviews, and obtain blood from arms 1, 2, 3, and 4.
18 months: Complete follow up survey, interviews, and obtain blood from arms 2, and 4.
18 months-24 months: Monitor electronic health record for arm 1, 2, 3, and 4.
Ongoing: Call all mentors every month to reinforcetraining and determine mentor-mentee call
frequency. Call all mentees at 1 and 3 months to assess hypoglycemic symptoms.
2.3.
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 our previous experience we anticipate having to screen between 1,600-2,000 charts to
identify 492 poorly controlled diabeticveterans and 206 mentors whowill be eligible and willing to
participate.
Similarly we expect to screen 1000 additional charts to identify 206 mentors who are eligible and
willing to participate, as well as mentors to replace those who withdraw.
2.3.1.2.
Other site
2.3.2.
Does this protocol employ an Honest Broker? DYES XNO
2.3.2.1. Ifyes, provide name of individual.
2.3.2.2. Ifno, explain who will access the charts/records.
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2.3.2.3.
Describe from what database charts/records/data will be accessed.
3.
Future Use of Data and Re-Contact, ifapplicable. N/A
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:
3.1.1. Where will the data be stored?
3.1.2. Who will have access to the data?
3.2.
Ifthe 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.
Ifsubjects 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 HbA1c and direct LDL on three-four 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 CMC 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 CMC 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.
N. Genetic Testing, if applicable N/A ,
1.
Explain ifthe study is looking for an association between a genetic marker and a specific
disease or condition, but at this point it is not clear ifthe genetic marker has predictive value.
1.1.
The uncertainty regarding the predictive value of the genetic marker is such that studies
in this category will not involve participant counseling.
1.2.
Describe ifthe 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.
1.3.
Will the subject be notified of the results and the provision for genetic counseling?
•
Yes
D No D N/A
1.3.1.
Ifyes, explain further.
1.4.
If biological specimens are used in this protocol, please respond to the following
questions by checking the appropriate box:
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.
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•
•
•
NO
N/A
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1.5.
1.6.
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?
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.)
Will subjects be informed of results obtained from their DNA?
Will specimens be de-identified? DYES
DNO
•
N/A
1.5.1.
Ifyes, 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
O. Banking of Collected Specimens
1.
Will collected specimens be banked? DYES
XNO
QN/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. Ifyes, specify the location where specimens will be banked.
1.2.1.
Ifthe 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 foran Off-site Tissue Banking Waiver)? QYES
QNO
QN/A
1.2.2.
Ifapplicable, attach a copy of the VA Form 10-0436
1.3. Explain how destruction of banked samples will be substantiated.
P. Subject Recruitment (characteristics of the study population)
1.
Provide the planned or targeted enrollment at:
1.1.
CMCVAMC - 492 poorly controlled diabetic veterans and 206 mentors, as well as
mentors to replace those who withdraw.
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:
2.1.1.
Inclusion criteria
All participants and mentors will be type 2 diabetics. To be eligible they must have developed
diabetes after the age of 30. To ensure that we are targeting those most likely to benefit from
improving control we enroll diabetics with persistently poor DM control. Persistently poor DM control
will be defined as having an HbAlc > 8% on 2 different occasions inthe course of 24 months, with at
least 1 measure within 3 months of enrollment. Mentors for arm 2 will have previously been in poor
control and are now in good control, defined as having an HbAlc of > 8% inthe past 3 years and an
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•
•
•
•
•
•
•
•
•
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•
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•
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HbAlc < 7.5% within 3 months of enrollment. Also, to ensure that we are targeting those most likely
to benefit from improving control, participants will need to be between the ages of 30-75.
2.1.2.
Exclusion criteria
We will have minimal exclusion criteria. Patients will be excluded ifthey do not speak English or are
unable to understand the consents as exhibited by failing the mini quiz. Patients will also be
excluded ifthey have a severe speech impediment of any kind since they need to be able to
converse with a mentor or mentee over the telephone. Patients over the age of 75 will also be
excluded since it is unclear ifthey will derive the same benefit from getting their HbAlc in control.
2.2.
List all screening and/or eligibility requirements.
We will electronically create a list of CMCVAMC patients with at least two diagnosis codes for
diabetes (ICD-10 code 250) and least two laboratory tests infor an HbAlc. We will exclude people if
their current age is s 30 and > 75 years of age. We will then review the list and determine who
qualifies as a potential mentee and a potential mentor. Letters will be sent to potential participants
letting them knowthat they may be eligible for a study with a briefdescription of the study and give
them a number ifthey would liketo learn more or to request no further contact. We will also notify
potential participants that ifwe do not hear from them we will give them a call in the following weeks.
Potential mentors will be identified and contacted in a similar manner.
2.3.
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 an additional description of the study
and for those interested we will ask them at what age they developed diabetes. Those who indicate
they developed diabetes before the age of 30 will be excluded from participating. The same will be
true for when we contact potential mentors. We will also ask them about how comfortable they are
with speaking English. Those who indicate discomfort with speaking English or are unintelligible
over the phone will also be excluded from participating.
2.4.
Not Applicable; subjects not recruited; chart review. •
3.
If applicable, indicate what populations will be targeted for recruitment as participants.
Check a 1that apply.
Males
X
Females
X
Inpatients
•
Outpatients
X
VA Employees
•
Non-English Speaking**
•
Veteran Family members***
•
Non-Veterans***
•
Other (Specify)
•
Not Applicable, chart review
•
3.1.
**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
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7.
well as the English version, needs to be forwarded to the IRBfor approval. Translator
certification is also required.
3.2.
***lf non-veterans will be recruited for this study, explain why sufficient veterans are not
available to participate inthe project FVHA Handbook 1200.5. paragraph 16a]. Veteran's
spouses/partners, caregivers, etc. are considered non-veterans for the purposes of this
study.
3.3.
***Has approval to recruit non-veterans been received from the ACOS/R&D and
Medical Center Director?
3.3.1.
X 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? DYES X NO
If yes, check all that apply.
Race
American Indian or Alaskan Native
•
Asian
•
Black or African American
•
Native Hawaiian or other Pacific
Islander
•
Black, not of Hispanic origin
•
White, not of Hispanic origin
•
Other
•
Ethnicity
Hispanic or Latino
•
Not Hispanic or Latino
c
Other
c
4.1.
Provide justification why this/these group(s) was/were chosen
What is the age range of participants? Check all that app y
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
•
•
•
•
Are there specific reasons why certain populations (i.e., age, gender or ethnic groups)
are excluded as participants?
IEIYES
X NO
QN/A
6.1.
Ifyes, specify reasons.
We excluded people inthe age groups younger than 30 years
and older than 75 years of age. Patients under the age of 30 were excluded to ensure
we are identifying a population with type 2 diabetes, and patients over the age of 75 will
also be excluded since it is unclear ifthey will derive the same benefit from getting their
HbAlc in control.
Does the project require enrollment of the following classes of participants?
YES
NO
a.
Employees
•
X
b.
Individuals with impaired decision making capability
•
X
c.
Pregnant women
•
X
d.
Economically and/or educationally disadvantaged persons
•
X
e.
Prisoners
•
X
f.
Illiterate, limited, or no English language proficiency
a
X
g.
Terminally ill patients
a
X
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While the study does not require the enrollmentofthese groups we anticipate that we will enroll
economically and/or educationally disadvantaged people as well as people who may have limited
health literacy. All study materials including consent forms will be read to participants. Only those
who fail the mini-quiz and thus seem not to comprehend the consent process will be excluded.
7.1.
Ifapplicable, what is the justification for including any of the above classes of
participants in the project?
7.2.
Ifthe 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.
8.
Describe the exact plan how subjects will be identified and recruited for the study.
8.1.
Discuss methods, e.g., referrals from physician offices, clinics, programs, or through
advertisements and brochures.
We will electronically create a list of CMCVAMC patients with at least two diagnosis codes for
diabetes (ICD-9 code 250 and ICD 10 codes starting with E11) and at least two laboratory tests infor
an HbAlc. We will exclude people iftheir current age is ^ 30 and > 75 years of age. We will then
review the list and determine who qualifies as a potential mentee and a potential mentor based on
past HbAlc values. This will be an ongoing process.
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 the project manager who they can
call ifthey would liketo learn more or to request no further contact. We will also notify potential
participants that ifwe do not hear from them we will give them a call in the following weeks.
Potential mentors will be identified and contacted in a similar manner.
When patients are contacted over the phone we will give them additional description of the study
and for those interested we will ask them at what age they developed diabetes. Those who indicate
they developed diabetes before the age of 30 will be excluded from participating. The same will be
true for when we contact potential mentors. We will also ask them about how comfortable they are
with speaking English. Those who indicate discomfort withspeaking English or are unintelligible
over the phone will also be excluded from participating.
Those interested in participating in the study will be invited into the CMC VAMC for a face to face
meeting with the study team. Atthat time if still interested participants and mentors will complete the
consent process in person including completing a mini-quiz about the process. Those who fail the
mini-quiz will be excluded from the study at that time; however, they will be reimbursed the $50 for
coming in for an in person visit. We anticipate almost everyone who comes infor a face to face visit
will be entered into the study.
9.
9.1.
If using a clinic, be specific about who will identify the potential subject and howthat
information will be transmitted to the research staff.
9.2.
Ifsnowball method will be used, discuss the process and how the first individuals will be
recruited.
9.3.
Describe how information will be disseminated to subjects, e.g. handouts, brochures,
flyers and advertisements (include allrecruitment materials with this submission).
10.
Informed Consent
10.1.
Informed Consent will not be sought. •
10.2.
Written informed consent from participants (VA Form 10-1086 is attached). X
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10.3.
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). •
10.4.
Request Waiver of Documentation of Informed Consent •
10.5.
List the title of the key personnel involved in the following activities:
10.5.1.
Person Obtaining Consent
10.5.1.1.
Provide the title(s) of individual(s) Program Specialist
10.5.1.2.
Type of training received to perform this process CPRS training,
CITI training, HIPPA training, and scanner training.
10.5.2.
Pre-Recruitment Screening (the use of medical records and other data
bases to determine populations and individuals eligible for the study), Data
Base Programmer and Project Manager or Program Specialist
10.5.3.
Recruitment Process (the process in which individuals are contacted and
first introduced to the study and to the possibility of participating as subjects),
Project Manager or Program Specialist
10.5.4.
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), Project Manager or Program Specialist
10.5.5.
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), Project Manager or Program
Specialist
10.5.6.
Include the breakdown of each individual's responsibilities:
10.5.6.1.
Principal Investigator, Judith A.Long, M.D. will be responsible
for the oversight of this entire study
10.5.6.2.
Co-Principal Investigator, N/A
10.5.6.3.
The Project Manager Jennifer Gutierrez or Research Coordinator,
Tanisha Dicks or other IRB approved research staff will be
responsible for the IRB administration, screening, the recruitment
and consent, data collection including measuring BMI, blood
pressure, and interviews (over the phone and in-person). They
will also be responsible for training the mentors and mentee-
mentor coordination.
10.5.6.4.
Additional research staff by title, The Project Manager Jennifer
Gutierrez or Research Coordinator, Tanisha Dicks will be
responsible for IRB administration.
10.6.
Will informed consent be obtained from potential subjects prior to determining eligibility?
Dyes
x no
Qn/a
10.6.1.
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
diabetes, in the correct age range, with the lab results as described above. Please see
the attached HIPAA Waiver of Individual Authorization for Disclosure of Protected Health
Information for approval of this activity.
10.7.
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 is complete the patient will be enrolled in the study.
10.8.
Describe:
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10.8.1.
The process when informed consent will be obtained and protecting patients'
privacy.
Informed consent will be obtained at the CMC 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 audio privacy. All study materials including informed consent forms will be read
to the participant.
10.8.2.
Any waiting period between informing the prospective participant and
obtaining consent. No
10.8.3.
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 Philadelphia 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 travel and cover the participant's
time.
10.9.
Provide the language
10.9.1.
used by those obtaining consent Please see attached script.
9.9.2
understood by the prospective participant or the legally authorized
representative Please see attached script.
10.10. Provide location where informed consent will be obtained. The CMC VA Medical
Center
11.
Waiver or Alteration of Informed Consent Requirements/Waiver of Requirement to
Obtain Documentation of Informed Consent
11.1.
Are you requesting a waiver or alteration of informed consent? (Check all that apply)
11.1.1.
NoX
11.1.2.
Yes; providejustification. •
11.1.3.
Yes; for recruitment purposes only.
•
11.1.3.1.
An IRB may approve a consent procedure which does not
include, or which alters, some or all of the elements of informed
consent set forth in this section, or waive the requirements to
obtain informed consent provided the IRB finds and documents
that:
•
•
1. The research involves no more than minimal risk to the
subjects;
•
•
2. The waiver or alteration will not adversely affect the
rights and welfare of the subjects;
•
•
3. The research could not practicably be carried out without
the waiver or alteration; and
t
•
4. Whenever appropriate, the subjects will be provided
with additional pertinent information after participation
•
•
5. The research or demonstration project is to be
conducted by or subject to the approval of state or local
government officials and is designed to study, evaluate, or
otherwise examine:
a.
Public benefit or service programs;
b.
Procedures for obtaining benefits or services under
those programs;
c.
Possible changes in or alternatives to those programs or
procedures; or
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d.
Possible changes in methods or levels of payment for
benefits or services under those programs.
11.2.
Are you requesting a waiver to obtain documentation of informed consent?
11.2.1.
NoX
11.2.2.
Yes; providejustification. •
11.2.2.1.
An IRB may waive the requirement for the investigator to
obtain a signed consent form for some or all subjects if it finds
either:
•
•
1. That the only record linking the subject and the research
would be the consent document and the principal risk would
be potential harm resulting from a breach of confidentiality.
Each subject will be asked whether the subject wants
documentation linking the subject with the research, and the
subject's wishes will govern; or
•
D 2. That the research presents no more than minimal riskof
harm to subjects and involves no procedures for which written
consent is normally required outside of the research context.
•
NOTE: In cases in which the documentation requirement is
waived, the IRB may require the investigator to
provide subjects with a written statement regarding the
research.
Q. 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 participants will receive $50 for each in person visit. Mentors will also receive an additional
$20 per month ifthey call their mentee 4 times per week. Mentors and mentees will receive an
additional $40 for each qualitative interview completed.
2.
Provide the schedule for compensation. Baseline, 6 months, 12 months, and for arm 2 and 4
18 months.
2.1.
Per study visit or session. $50
2.2. Total amount for entire participation. Arm 1 $150, Arm 2 up to $460, Arm 3 up to $270,
Arm 4 up to $320.
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 CMC VA cashier.
4.
Iffinancial compensation will be prorated, explain the process. N/A
5.
NotApplicable- •
R. Withdrawal/Early Withdrawal
1.
Describe how and when a subject may withdrawal from the study. Subjects may withdraw at
any time. Any request may either be expressed verbally or in writing.
2.
Provide procedures for the orderly termination of participation by the participant and ifany
consequences would result from early withdrawal from the study.
There will be no consequence of early withdrawal. After submitting a request to withdraw or
written or verbally the study participation will be terminated. Ifa mentor withdraws before 4
months, his or her mentee will be re-matched to another mentor.
3.
Explain ifsurvival data is required. If so, clarify how data will be obtained. N/A
4.
Not Applicable; subjects not recruited; chart review.
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S.
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
1.1.2.
Psychological Minimal
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
1.1.8.
Assess the likelihood and seriousness of such risks. Minimal
1.1.9.
Other
1.2.
Specify what steps will be taken to minimize these risks.
Patients will need to complete a mini-quiz after completing the informed consent to assure the
researchers they understand the consent procedure. 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. Mentors and mentees will be
informed that their conversations are confidential and should not be shared. Mentees will need
to provide a working phone number which will be provided to the mentor. Mentees will be
informed of this process up-front.
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 VA servers. Neither data
base will be removed from the VAserver and will be behind VAfirewalls. Paper files will be
kept in locked filing cabinets and will not leave the CMC VAMC 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 data base.
1.3.
Ifmethods of research create potential risks, describe other methods, ifany, that were
considered and why they will not be used. N/A
1.4.
Ifchart review, breach of confidentiality is always a concern. Specify what steps will be
taken to minimize these risks.
Charts will be reviewed to determine ifa potential subject may be eligible for the study. Only
IRB approved study personnel will access charts from VA computers during work hours.
Abstraction will be limited to determine eligibility only.
Chart will also be reviewed 6 months after the last in-person visit has taken place (and for those
lost to follow-up should have taken place). Minimal data will be abstract from the chart -
additional HbAlc, LDLs, and BP measurements from the time of entry into the study to the day
of the chart abstraction. Only those with IRB approval will abstract this data and it will only be
done on the VA premises. Data written on paper abstraction tools will be entered into the
analytic database house behind the VA firewall. Paper documents will be kept on site and in
locked filing cabinets in the CMC VAMC Annex.
2.
Potential Study Benefits
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2.1.
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.
In our pilotstudy, poorly controlled diabetics who received mentoring on average improved their
HbAlc by 1%. This is a large and clinically significant improvement. Ifimprovements persist
then the participant may reduce his or her risk of future complications from diabetes. This
study in part will help us understand better if risks persist. This study has the potential also to
add to our knowledge about how to better to support diabetics in general with behavioral
change.
2.2.
Ifthe subject does not receive any direct benefit, then it must be stated here and in the
consent form.
While we hope that subject will receive benefit it is likely that some participants will not benefit
especially those who are randomized to usual care.
3.
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.
T.
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 reguire a DSMB with any
study.)
1.
Will an independent DSMB or DMC oversee the project? IEIYES
DNO
DN/A
2.1.
Ifyes, please provide contact information for the DSMB or DMC or Coordinating Center
Representative and attach a copy of the charter.
Name: Joshua Metlay MD
Phone Number: (610) 519-9168
Title: DSMB Chair
E-mail: jmetlay@exchange.upenn.edu
2.
If a DSMB or DMC will not monitor this study, who will monitor this study? Check all that
apply.
X Principal Investigator
•
Sponsor
•
VA Cooperative Studies Program
•
Safety monitoring committee
U. Data Monitoring (Monitoring plans describehow a monitor, independent of the studyteam, regularly
inspects study records to ensure the study is adhering to the study protocol and applicable research
regulations and CMCVAMC reguirements. Monitoring plans do not necessarily reguire 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 reguire
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.)
Hypoglycemic events will be monitored at 1, 3 and 6 months. All serious adverse events will be
reviewed bythe PI and reported to the IRB as well as the DSMB. We do not expect events to differ
by arm based on our prior research.
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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 reported within 24 hours of our awareness of said
breach.
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. Ifthere 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
Ifwe 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 We will only use a depression screening tool and not assessing for
depression. If the participant is willing and they screen positive for depression we
will notify the participant's primary care provider.
3.2.
Suicide Will not be assessed
3.3.
Abuse Will not be assessed
4.
Statistical Analysis
4.1.
Include statistical power calculations and the assumptions made in making these
calculations.
We will randomize 72 mentees from stage 1 to each arm of stage 2. To achieve 80% power to
detect a 0.8 unit change in HbAlc, with standard deviation of 1.6, a sample of 64 patients per arm
would be required. But to protect against possible attrition, we will inflate that by 10% and enroll
72 participants into each arm. Literature and guidelines suggest that an average decrease of 1
unit in HbAlc would provide a clinically meaningful improvement in health. We chose a 0.8 unit
change to be conservative. We base our standard deviation of 1.6 on our pilot study and other
studies of low control DM populations.
For stage 2 we will also randomize poorly controlled diabetics into mentoring or usual care arms.
We will need 72 in the usual care arm (to be mentored by the 72 stage 1 mentees who become
mentors). Since usual care for stage 2 can be combined with usual care for stage 1, there is no
need for a 1:1 randomization. Initially, a 1:1 randomization was used, but after evaluation we
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believe we can now switch to a 2:1 randomization to avoid recruiting more usual care patients
than necessary. With this change we will enroll approximately 56 patients to usual care in stage
2.
In order to assure 72 in each arm for stage 2, we will need a total of 144 mentees in stage 1.
Again, to protect against possible attrition, we inflate that by 16% and enroll 171 mentees in stage
1. A corresponding number of mentors (171) will be recruited for stage 1. There will be no
randomization of mentors in stage 1. Since usual care for stage 1 can be combined with usual
care for stage 2, there is no need for a 1:1 randomization. Initially, a 1:1 randomization was used,
but after evaluation we believe we can switch to a 2:1 randomization to avoid recruiting more
usual care patients than necessary.
With this change we will enroll approximately 139 patients to
usual care in stage 1.
The combined number of poorly controlled diabetic patients receiving usual care will be
approximately 195. The number of poorly controlled diabetic patients receiving peer mentoring
will be 232 (171 in stage 1 and 72 in stage 2). The number of mentors in stage 1 will be 171, and
the number of mentors in stage 2 will be 72 (from among those who received mentoring in stage
1). The total number of patients in the study will be 594.
A recent analysis of clinical data from the CMC VAMC and its surrounding CBOCs indicate that in
the last year there were 1,248 patients who would have qualified to be mentees and 1,810 who
would have qualified to be mentors.
4.2.
Define plans for data and statistical analysis, including key elements of the statistical
plan, stopping rules and endpoints.
For Stage 1: We will test these primary hypotheses using an unadjusted intent-to-treat analyses,
i.e., with adjustment for only baseline HbAlc. The primary tests will assess the significance of the
coefficients associated with the treatment assignment in a longitudinal linear model of the
repeated HbAlc as a function of treatment, where the active group (peer mentoring) is compared
to the control group via an indicator variable. Standard t-tests will determine whether a significant
difference in HblAc improvement occurred between the treatment arm compared to the control
arm. To account for the fact that we are doing multiple tests, we will use the Bonferroni method
and consider a treatment to be significantly different than the control ifthe p-value is less than
0.05/2=0.025.
Stage 2 Analysis:
H2. Compared to usual care, veterans who receive peer mentoring from former mentees will have
improved glucose control as measured by HbAio BP, LDL levels, DM quality of life, and depression
scores: We will examine the effectiveness of the intervention at 6 months and further examine
sustainability at 12 and 18 months. 18 month assessments will only be of HbA1c, BP, and LDL levels as
derived from the EMR. We will test these primary hypotheses using an intent-to-treat (ITT) analyses, i.e.,
including all patients who completed a baseline assessment, as randomized. We will use linear and
random effects longitudinal models to perform the ITT comparisons at each of the follow-up visits. Our
primary outcomes will be HbA1c, BP, LDL levels, DM quality of life, and depression scores. Our models
will include a random effect for patient. The models will include the following fixed effects: a main effect
for follow-up visit (with baseline visit as the reference), intervention group, and their interactions. Tests of
the interaction terms will be used to determine the ITT difference between groups with respect to change
from baseline. To examine whether veterans who received peer mentoring from former mentees have
improvedglucose control, BP, LDL levels, DM qualityof life, and depression scores compared to
veterans in the usual care group at 6 months, compared to baseline, we will implement these random
effects models with mentee HbA1c, BP, LDL, DM quality of lifescore, or depression score as the
dependent variable. The ITT test for effectiveness will be based on HbA1c and will be two-sided, with
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alpha=0.05 and will be based on the magnitude and statistical significance of the time*intervention
interaction term at 6 months. To examine sustainability of improvement in glucose control, BP, LDL
levels, DM quality of life, and depression scores we will use the same test, but will examine the
intervention group*12 month time interaction term. To examine sustainability of improvement in glucose
control, BP, and LDL levels at 18 months we will again use the same test, but will examine the
intervention group*18 month interaction term.
We will check model fit by inspecting residual plots, and will assess improvement in fit with different
correlation structures for the random effects. While we do not anticipate confounding in our ITT estimates
because of the stratified and blocked randomization of patients, confounding due to imbalance in patient
characteristics may still occur by chance. Tests for evidence of confounding will be performed by
comparing baseline characteristics, between control and intervention group. Confounders will be
identified as variables that are significant at the 0.20 level and we will include these as adjustment
variables (fixed effects) in our analyses. These multivariable models will reduce the impact of potential
bias due to confounding, as well as improve the statistical power by reducing the amount of unexplained
variation in the outcome variable.
Extensive efforts will be made to collect complete information on each participant enrolled in the study.
While we do not expect to be confronted with nonignorable missing data, we will nevertheless assess the
sensitivity of treatment effect estimates to missing outcome data in a number of ways. We will compare
the number of visits completed by participants in each arm as an additional secondary outcome, using
the chi-square test. We will also compare observed characteristics of subjects with complete follow-up to
those with missing data and will attempt to ascertain the reasons for missing data in subjects with
incomplete follow-up.
H3: Compared to past mentees who are not randomized to becoming a mentor, past mentees
randomized to becoming a mentor will have better glucose control. BP, LDL levels. DM gualitv of life, and
depression scores: To examine whether past mentees who become mentors have better glucose control,
BP, LDL levels, DM quality of life, and depression scores than past mentees who do not become
mentors, the dependent variable in this analysis will be past mentee HbA1c, BP, LDL level, DM quality of
life score, and depression score and the intervention group will be the randomization group for former
mentees. As we described above, tests of the interaction terms for each follow-up time (i.e. 6, 12 months,
and 18 months) with intervention group will be used to determine the ITT difference between groups with
respect to change from baseline HbA1c, BP, LDL level, at each follow-up time and DM quality of life
score, and depression score at 6 and 12 months.
Testing of Secondary Quantitative Hypotheses:
H4. In those randomized to being a mentee. explore mentor characteristics associated with improved
outcomes. Predictors to be evaluated include past mentoring dose of the current mentor, the mentor's
past change in HbA1c, the mentor's starting HbA1c, current mentoring dose provided by the mentor, the
mentee's evaluation of the mentor, and the mentor's depression score at baseline. Based on the
literature and our pilot studies, we have opted to use past mentees as mentors regardless of a. time
passed since they were a mentee, b. the amount improvement in HbA1c when they were a mentee, or c.
their starting HbA1c in this study. We will evaluate ifany of these mentor variables are associated with
mentee change in HbAic, BP, LDL level, DM quality of lifescore, and depression score at 6 and 12
months and HbAic, BP, and LDL level at 18 months.
Assessment of Hypoglycemia: In order to assess the relative frequency of minor hypoglycemic symptoms
we will summarize the number of participants in each study arm reporting 0, 1-3, or >3 minor
hypoglycemic symptoms per month. In order to compare average rates per person per month, using all
available data, we will fit a generalized linear mixed model with random subject intercepts and test for
differences between treatment groups. Based on our previous study we expect very few major
hypoglycemic events, we will compare differences by arm using a Fisher's exact test. If requested bythe
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Data Safety Monitoring Board (DSMB - see Section E.5 in Human Subjects), preliminary analyses of
minor and majorhypoglycemic events will be completed beforethe completion ofthe study.
Qualitative Analyses:
Process Evaluation: To facilitate later deployment of results and to improve the design of future
interventions, we will engage in a qualitative process evaluation throughout the study to learn why some
study participants succeed in changing behavior and others do not, and whatelements ofthe approach
were acceptable to participants.115 In particular, we are interested in learning about the mentor-mentee
relationship. All interviews will be audio-taped, transcribed, and content-analyzed. We will use the
framework of adult learningtheory to analyze the results. We will look for evidence of the following from
successful mentor mentee pairs: 1. the mentee expressed a perceived a need to change, 2. the process
was relevant to the mentee's needs, 3. the process motivated the mentee to change, 4. the mentee felt
the mentor listened to the mentee and supported the mentee's identified goals, 5. The mentor was
motivated to be a mentor, 6. the mentor tailored their approach to the needs of the mentee, and 6. the
mentor fostered and enhanced the mentee's sense of self-efficacy regarding diabetic health behaviors.
However, whilewe use the lens of adult learning theory to guide the analysis we will keep an open mind
to the potential that this framework does not adequately characterize all aspects ofsuccessful pairs and
will lookfor common themes that might lie outside of this framework. Following this process of careful
reading and reflecting upon the interview transcripts and discussing them among ourselves will provide
an opportunity to understand the mechanisms bywhich peer mentoring operates and identify themes that
emerge from the data.
After extensive discussion of the transcripts and identification of important themes, we will generate a
Working Coding Scheme (WCS) based on the theoretical model and refine itthrough content
evaluation of the first few interviews. Once we have developed an initial WCS, Dr. Long and the project
manager will independently recode the content of the already coded interviews, and through an
iterative process with Dr. Shea, discrepancies will be resolved until a final coding scheme is developed.
This similar process of double coding with resolution of disagreements will then be applied to coding all
the transcripts.
The final WCS will be used as an analytic tool for identifying patterns in the data, answering conceptual
research questions, and generating new hypotheses grounded in the data. For analysis oftranscripts,
we will use NVivo software for qualitative data analysis. We will use the software to develop counts of
codes stratified by change in HbA1c as well as by the mentor's past experience with receiving
mentoring (optimal/suboptimal) and the mentor's past success with improving their HbA1c. We have
used this analyticapproach previously and found it a meaningful way by which to identify themes and
understand the emphasis placed on the theme by the populations as a whole. These analyses will be
used to refinethe conceptual model and expand our understanding of how peer mentoring functions. In
addition, comparisons will be made to determine ifthere is thematic consistency between mentors and
mentees.
By collecting qualitative data sequentially in conjunction with the quantitative studywe will be ableto
interpret and contextualize our quantitative findings and inform the implementation of peer mentoring
programs.
V. Privacyand Confidentiality (Privacy refers topersons andtotheir interest in controlling the access
of others to themselves.) (Confidentialityrefers to protecting information from unauthorized disclosure
orintelligible interception.) (Investigator shouldcontact the Privacy Officer for additional details.)
1.
Indicate the type of data that will be received by the Principal Investigator. Check all that
apply.
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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, itis notconsidered de-
identified.)
1.2.
X 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 specificsubject by a code rather than a direct identifier. If coded
is checked, specify:
1.3.1
Explain who will maintain the linkor code.
1.3.2
Describe who will have access to the link or code.
1.3.3
Provide exact details for how the data is coded.
1.3.4
Does the project require the use of existing Protected Health Information (PHI) from a
database, medical records, or research records? X YES
QNO
QN/A
2.1.
Ifyes,
2.1.1.
Specifythe source ofthe 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. See below:
For contact purposes and tracking: name, address, phone numbers, date of birth, and social
security number.
For determining eligibility: diagnosis codes of diabetes, HbAlc levels, and date of birth.
Please see the attached HIPPA waiver requesting permission to access this data.
2.2.
Ifthe 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.
Will PHI be collected prior to obtaining informed consent? XYES
QNO
DN/A
3.1.1.
If yes, complete and provide a HIPAA Waiverof Individual Authorization for
Disclosure of Protected Health Information with this submission.
HIPAA Identifiers - Indicate the PHI that will be collected from project participants directly or
indirectly.
4.1.
XName
4.2.
XAll geographic subdivisionssmaller than a State, including street address, city,
county, precinct, zip code, and their equivalent geocodes, except forthe initial three
digits ofa zipcode if, according to the current publicly available data from the Bureau of
the Census
4.3.
X All elements of dates (except year) for dates directly related to an individual, and all
ages over 89 and all elements ofdates (including year) indicative ofsuch age, except
that such ages and elements may be aggregated into a single category ofage 90 or
older.
4.3.1.
X Birth Date
•
Date of Death
4.3.2.
•
Dischargedate
•
Admission date
4.3.3.
•
Appointment Dates |El Other Dates (e.g. labtests, x-rays, MRI, etc.)
HbAlc and LDL blood draw dates, and BP dates
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4.4.
XTelephone numbers
4.5.
•
Fax numbers
4.6.
•
Electronic mail addresses
4.7.
X Social Security Number
4.8.
•
Medical record numbers
4.9.
•
Health plan beneficiary numbers
4.10.
•
Account Numbers
4.11.
•
Certificate/license numbers
4.12.
•
Vehicle identifiers and serial numbers, including license plate numbers
4.13.
•
Device identifiers and serial numbers
4.14.
•
Web universal resource locators (URLS)
4.15.
•
Internet protocol (IP) address numbers
4.16.
•
Biometric identifiers, including fingerprints, voiceprints, audio recordings
4.17.
•
Full-face photographic images and any comparable images
4.18.
•
Any other unique identifying number, characteristic, or code
4.19.
X Personal and Family History
4.20.
•
History and Physical Examination
•
Progress Notes
4.21.
•
Discharge Summary(ies)
•
Photographs, videotapes, other images
4.22.
•
X-Ray
•
HIV (testing or infectious disease) records
4.23.
XDiagnostic/Laboratory tests
•
Sickle cell anemia
4.24.
•
Drug Abuse Information
•
Behavioral Health notes
4.25.
•
Alcoholism or Alcohol Use
•
Operative Reports
4.26.
•
Billing records
X Medication List
4.27.
•
Health Summary Reports
•
Anatomic Pathology Report
4.28.
lElOther Records: Sex and race
5.
Will participants be contacted from existing PHI? XYES
DNO
DN/A
5.1.
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 participant once identified will first be sent a letter of introduction letting them know
about the study and giving them a number ifthey 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 introducedto them and they will be asked ifthey would be interested in
participating in the study. See attached letterofcontact and scriptfor discussing the project with
potential participants on the phone.
6.
Provide the titles of the exact individuals who will have access to the collected data.
6.1.
Explain why these individual will have access to this data.
The titles of the individuals with access are Principle Investigator, Project Manager, Program
Specialist and Data Base Programmer. Theywill have access to identify, select, and enroll
participants to be part of the study.
W. Information Security (Contact theInformation Security Officer for additional assistance regarding
confidentiality (storage/security) of research data.)
1.
Provide the precise plan how data isto be collected or acquired (repeatthe same information
as listed under "Data Collection" section of this form.
Surveys will be read to participants and answers will either bedirectly input into a computer database
orwritten onto paperforms and then transferred to a database at a latertime. The database will
reside on VAservers behind the VAfirewall and will never be removed from the server. Paper
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records will be stored at CHERP behind an electronically locked entrance, a key-locked door and in a
key-locked cabinet.
Qualitative interviews will also be read to participants and answers will voice recorded. Interview
data will be stored on the VA server behind VA firewalls. Data about the number of calls per month
made by the mentor will be collected over the phone, andagain responses will either be entered
directly into a database or first onto paper and then into the database.
Data about hypoglycemic symptoms will be collected over the phone, and responses will either be
entered directly into a database or first onto paper and then ontothe database.
Lab results will be obtained from the lab or via CPRS and entered into the secure research database.
2. Provide a listing ofthe exact research data thatwill be stored, including but not limited to signed,
original informed consent and HIPAA authorization forms, case report forms, etc.
Hbalc, blood pressure, direct LDL, BMI, self-reported demographics, survey data examining diabetes
quality oflife, depression symptoms, hypoglycemic symptoms, attachment style, goal commitment,
diabetes health history, general health history, self-efficacy, self-management behaviors,
hypoglycemic symptoms, informed consent form, HIPPA authorization form, and exit interview
data.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, otherapplicable VA and VHA requirements, and as described in the approved research
protocol or as specifically described in the Preparatory to Research Form.
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. Access is limited tothestudy staff by the
database administrator.
Hard copy-based research data will be stored at the CMC VA Medical Center Annex, (file room 17) in
a filing cabinet onthe secondfloor. This room is located at CHERP, which issecured by a lock and
key, and thefiling cabinet containing thedata will besecured by lock and key. While files are actively
in use, paper records will be held in the CMC 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.
3.
Indicate how project's research data (original and all copies) will be stored and provide
corresponding security systems. Project research data both original and 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 CHERP/CEPACT servers are located inthe secure CMCVAMC server room, which is the OI&T
Server Room that has double locksand a security alarm and cameras, which is located in Room 001
of Building 1 of the main CMCVAMC.
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The filing room on the second floor ofthe Annex and is located at Room 17, and the cabinet is locked
inside of Room 17. Activefiles will be stored in a locked filing cabinet (M133) in PROMISE, Suite 200,
located on the second floor of the Annex.
5.
Explain howdata is to be transported or transmitted from one location to another. ADA
transcription will give us space on their secured server to save our data until it is
transcribed then we will erase everything on their server.
5.1. Informed Consent discloses PHI transported or transmitted off-site. [x]YES •
NO •
N/A
5.2. HIPAA Authorization discloses entitiesto whom PHI will be transported or transmitted. •
YES Kl NO DN/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. ADA
Transcription, so the qualitative interviews can be transcribed. We do not have
the manpower on staff to transcribe.
5.3. If yes, list the exact data that will be transmitted. Sept 2015-Dec 2015
5.4. If yes, explain how data will be protected during transmission outside of CMCVAMC. This
data will be on secured servers with companies that the CMCVAMC previously
worked with and approved. In addition, ADA has signed a confidentiality and non
disclosure agreement.
5.5. Off-site, provide exact location ADA Transcription 127 Kings Road Westampton, NJ
08060 (If off-site, attach at least one of the following.)
5.5.1. Data Use/Transfer Agreement KlYES
DNO
X N/A
5.5.2. Off-Site Storage/Transfer of Research Data DYES
QNO
X N/A
5.5.3. Memorandum of Understanding DYES
DNO
X N/A
5.5.4. (Note: VA data disclosed to a non-VA investigator at an academic affiliate for
research purposes needs to be approved by the UnderSecretary 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 Long, MD, Anne Canamucio, Jennifer Gutierrez, Tanisha Dicks and Richard Sorrelle, will have
full access to the data, through the secure electronic server and the hard copy paper-based data in
the locked cabinets. ADATranscription will have access to the qualitative interviews
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).
Judith Long who is the Principle Investigator, Anne Canamucio, Jennifer Gutierrez who is the project
manager, and Tanisha Dicks and Richard Sorrelle, who are the program specialists, will have full
access to the data and be responsible for the security of the information.
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
CMC VA Medical Center Annex, (file room) in a filing cabinet. This room is located at CHERP, which
is secured bya lock and key, and the filing cabinetcontaining the data will be secured by lock and
key. Paper recordsthat are actively in use will be held in the CMC VA Medical CenterAnnex
PROMISE (suite 200) on the second floor, in a key-locked filing cabinet behind an electronically
locked entrance and a key-locked door.
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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. Access is limited to the study staff by the
database administrator.
9.
Give security measures thatmust be in place to protect individually identifiable information if
collected or used.
All identifiable information collected byhard copypaper-based data will be kepton VA property under
lock and key in the cabinet located in the locked file room. All electronic data will have limited access,
granted only tostudy staff, including the principle investigator and the program specialist under
supervision of the database administrator.
10.
How and to whom a suspected or confirmed loss ofVA information is to be reported.
CMCVAMC Information Security Officer and Privacy Officer will be notified within one hour ofthe
improper useordisclosure, as well as the IRB, Associate Chief of Staff for Research (ACOS/R) and
Research Compliance Officer.
11.
Identify anycircumstances that may warrant special safeguards to protect the rights and
welfare ofsubjects who are likely to be vulnerable including, butnot limited to, those subjects
who may be susceptible to coercion or undue influence, and describe appropriate actions to
provide such safeguards.
Not applicable. Wewill not be recruiting patients who are considered vulnerable populations orthose
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. KlYES •
NO DN/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
CMC VAMC ot the CMC VAMC Annex. Electronic PHI will be stored on
VA servers behind the VA fire wall and will not be removed.
12.2.
PVAMC secure server. XYES QNO QN/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. DYES XNO D
N/A
12.2.2.1.
Ifyes, identify the external drive.
12.3.
Off-Site server DYES X NO flN/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.
12.3.2.
Data Use/Transfer Agreement DYES DNO X N/A
12.3.3.
Off-Site Storage/Transfer ofResearch Data DYES DNO XN/A
12.3.4.
Memorandum of Understanding DYES
DNO
X N/A
13.
Explain how data isto betransported ortransmitted from onelocation toanother. ADA
transcription has secure servers.
14.
Informed Consent discloses PHI transported ortransmitted off-site. XYES DNO QN/A
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15.
HIPAA Authorization discloses entities to whom PHI will be transported or transmitted.
X YES DNO DN/A
16.
List all entities or individuals outside CMCVAMC to whom data is to be disclosed, and the
justification for such disclosure andthe authority. Alpha Transcription in order totranscribe the
qualitative interviews and the Mixed Methods Research Lab in orderto code the interviews
17.
Clarify what protection exists for a database. Access is limited tothe study staff by the
database administrator.
17.1.
Data is stored:
17.1.1.
With identifiers - X YES
DNO
17.1.2.
Coded-^YES
DNO
17.1.3.
De-Identified - DYES
lElNO
17.1.4.
Provide the exact list of identifiers that will be stored. Name, social security
number, phone number, address, date of birth and age.
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 toapply for a Certificate of Confidentiality? DYES
QNO
|E]N/A
19.1.
If yes, provide a copy ofthe certificate with thisapplication orto 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 bythe National Archives and Records
Administration and are published inVHA'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
X. Qualification of the Investigators
Provide a description ofthe qualifications ofeach investioator/co-investigator and their specific
role in the study.
Judith A. Long, MD isthe primary investigator onthis study. She isan experienced researcher
inthe areas of social determinants of health, health disparities, and Diabetes Mellitus. She is
an Associate Professor of Medicine in the Division of General Internal Medicine at the Penn
School ofMedicine (SOM), the Director ofthe Penn SOM Masters ofScience in Health Policy
Research (MSHP), the Principal Investigator (PI) for the Penn NRSA Generalist Research
Training Grant, Associate Director of the Penn Robert Wood Johnson Clinical Scholars
Program (RWJ CSP) and Co-Chair of the Society for General Internal Medicine (SGIM)
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Disparities Task Force. She has more than 10 years of experience in clinical diabetes
management. Recently, her research has focused on interventions to reduce disparities in
health directing clinical research trials focusing on diabetes. She recently completed a VA
based randomized controlled trial (RCT) ofpeer mentoring andfinancial incentives for adults
with poorly controlled type 2diabetes and is currently the PI for a similar NIDDK-funded clinical
RCT which is being implemented in a non VA low-income minority population. This R01 also
includes costeffectiveness analyses similar tothose proposed here. She also has a multi-site
HSR&D MR evaluating delivery of care for patients with both diabetes and serious mental
illness. She will be responsibleforthe oversight ofthis entire study.
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 ifthey are potentially study related.
2.
PI should submit a current, dated CV with each new initial review.
Please see attached CV for Judith Long, MD.
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