Development and Pilot Testing of LIMIT: a Multicomponent Tool to Support Opioid Tapering
Phase: NA
Conditions: Chronic Pain
Sponsor: VA Office of Research and Development

Development and Pilot Testing of LIMIT: a Multicomponent Tool to 
Support Opioid Tapering
NCT04746833 
April 12, 2022

CMCVAMC IRB Form 101 
 
      Page 1 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center (CMCVAMC) 
Institutional Review Board (IRB) 
INITIAL IRB APPLICATION 
 
 
   Application and Submission Instructions (IRB Form 101) 
 
DO NOT CHANGE THE FORMATTING OF THIS DOCUMENT. 
DO NOT USE THIS FORM ON A MAC; IT WILL CHANGE THE FORMATTING 
OF THIS DOCUMENT, WHICH WILL MAKE IRB REVIEW MORE DIFFICULT 
AND LENGTHIER. 
 
 - FOR CHECKBOXES - DOUBLE CLICK THE BOX - CHOOSE 'CHECKED'; 
HIT OK. 
 
      - FOR TEXT BOXES - CLICK IN SHADED BOX AND TYPE.   
 
 
The Principal Investigator (PI) is required to use this form to submit new 
research projects to the IRB. This form is to be used when there is 
interaction with human subjects. 
   
Each section of the application requires a response. 
 
Ensure all responses are consistent with the approved funded project, the 
informed consent, and the HIPAA Authorization, if applicable.  Ensure all 
sections of the application are completed or marked “Not Applicable.” 
 
One single-sided hard copy of this application form must be submitted to 
the IRB Office with ALL required signatures. 
 
The electronic version sent to the IRB Administrator must be Word documents, 
unless the form is already a PDF. 
 
This application form was designed to be self-explanatory with embedded 
instructions and guidance to follow as the form is being completed.  However, if 
any questions arise as the form is being completed, contact one of the IRB 
Administrators, Eileen.McCarthy-Dorsey@va.gov or Joan.Havey@va.gov. 
 
THERE MAY BE OTHER DOCUMENTS YOU WILL NEED FOR YOUR 
PROJECT, SUCH AS THE RESEARCH STAFF FORM, INFORMED CONSENT, 
HIPAA AUTHORIZATION/REVOCATION FORMS, ETC., WHICH CAN BE  
OBTAINED FROM  
Eileen.McCarthy-Dorsey@va.gov or Joan.Havey@va.gov   

CMCVAMC IRB Form 101 
 
      Page 2 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
TABLE OF CONTENTS 
Section 1:   PI's Information ..................................................................................................................... 3 
Section 2:   PI's Study Team Information ................................................................................................. 4 
Section 3:   Project Overview ................................................................................................................... 4 
Section 4:  Potential Risk/Benefit Analysis ............................................................................................... 6 
Section 5:  Human Participant Information ............................................................................................... 8 
Section 6:  Informed Consent ................................................................................................................... 9 
Section 7:  HIPAA Authorization for Project Participants ........................................................................ 10 
Section 8:  Participant Recruitment Information ..................................................................................... 10 
Section 9:  Payment to Participants ....................................................................................................... 11 
Section 10:  Biological Specimens ......................................................................................................... 12 
Section 11:  Privacy, Confidentiality, and Information Security in Research ........................................... 13 
Section 12:  FDA-Regulated and Other Products ................................................................................... 17 
Section 13:  Request for Expedited Review ........................................................................................... 18 
Section 14: Abstract ............................................................................................................................... 20 
Section 15: List of Abbreviations ............................................................................................................ 21 
Section 16:  Protocol Summary .............................................................................................................. 22 
1. 
Introduction .................................................................................................................................................... 22 
2. 
Objectives ....................................................................................................................................................... 25 
3. 
Resources and Personnel ................................................................................................................................ 25 
4. 
Study Procedures ............................................................................................................................................ 26 
5. 
Recruitment Methods ..................................................................................................................................... 28 
6. 
Informed Consent Procedures ........................................................................................................................ 29 
7. 
Inclusion/Exclusion Criteria ............................................................................................................................ 29 
8. 
Study Evaluations ............................................................................................................................................ 30 
9. 
Data Analysis ................................................................................................................................................... 30 
10. 
Withdrawal of Subjects ............................................................................................................................... 31 
11. 
Reporting .................................................................................................................................................... 31 
12. 
Privacy and Confidentiality ......................................................................................................................... 31 
13. 
Communication Plan for Multi-Site Studies or Studies being done at Non-CMCVAMC Locations ............ 32 
14. 
References (bibliography of cited literature) ............................................................................................. 32 
Section 17: Keywords ............................................................................................................................ 35 
Section 18: Institutional Support ............................................................................................................. 35 
Section 19: Data Management and Access Plan (DMAP) ...................................................................... 36 
Section 21: Attestation to Follow Federal Regulations ........................................................................... 39 
Section 22: Institutional Approvals ......................................................................................................... 39 
 
 
 

CMCVAMC IRB Form 101 
      Page 3 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
SECTION 1:   PI'S INFORMATION 
Project Title:  SUMMIT STUDY– 
Phase 2 
Initial 
Revised 
CMCVAMC Version Date/Version #:  3/24/2022 
1.
Name of Principal Investigator (PI) Manik Chhabra  
PI's VA Email: manik.chhabra@va.gov 
PI's VA Telephone Number: 215-823-4498
PI's VA Mailing Address: 3900 Woodland Ave, Philadelphia, PA 19104 
PI's Other Business Email: 
PI's Other Business Telephone 
Number: 
612-860-0053
2.
PI's Academic Degrees:  MD
2.1. PI's Board Certifications, if applicable:  Internal Medicine 
3.
PI's Employment Status: (Check all that apply)
  VA Employee  (#8ths) 
8/8 
  Other (VA WOC, IPA) 
Specify Appointment Type: 
3.1. For ORD-funded studies, is the PI at least a 5/8ths VA employee? 
Yes 
 - (skip to question 4)       No 
 - (answer question 3.2)     N/A 
3.2. If the response to 3.1 is no, is a copy of the ORD funding service approval waiver 
included as part of this submission? 
Yes 
     No 
 - If no, indicate when submitted for approval: 
4.
Describe the PI’s qualifications to act in the capacity as PI to do the research in this
project and attach a copy of his/her biosketch (Merit Review or NIH Format):
Manik Chhabra, MD, is the Principal Investigator (PI) and a staff physician at the CMCVAMC in 
Philadelphia. He is the Medical Director of the Indigo (PAIN) PACT, that focuses on patients with 
chronic pain who are prescribed high doses of opioids. He previously was a VA Advanced 
Research Fellow, and a Fellow in the Robert Wood Jones Clinical Scholars Program. He has 
experience in health services research, clinical trial design and analysis, and statistical analysis. 
He currently spends 50% of his effort on research and evaluation, and 50% on clinical and 
teaching activities. 
5.
Complete the questions below regarding the PI’s current research activities:
5.1. What current percentage of the PI time is devoted to research activities?  50% 
5.2. What percentage of the PI’s time will be devoted to this project?  10% 
5.3. How many active studies is the PI currently overseeing?  1 
5.4. How many of the above are multisite studies in which the PI is the overall PI? 0 
6.
Is/Are there Co-PI (s)?    Yes
 -(see additional questions below)    No 
6.1. 
If yes, indicate the following for each:    Name:  William Becker, MD  Site:  VA CT 
Healthcare System (VACHS), West Haven campus 

CMCVAMC IRB Form 101 
 
      Page 4 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
SECTION 2:   PI'S STUDY TEAM INFORMATION  
1. 
Study coordinator's contact Information.     
 N/A 
1.1. 
Name of Study Coordinator:  Tanisha Dicks   
Study Coordinator's VA Email: Tanisha.Dicks@va.gov 
Study Coordinator's VA Telephone Number: 215-823-5800 x7157 
Study Coordinator's VA Mailing Address: 3900 Woodland Ave, Philadelphia, PA 19102 
Study Coordinator's Other Business Email: 
Study Coordinator's Other BusinessTelephone 
Number: 
 
2. 
Does the above-named Study Coordinator have prior experience coordinating:  
2.1. 
A VA research study?  Yes 
        No 
 
2.2. 
Obtaining informed consent at the CMCVAMC?  Yes 
    No 
 
2.2.1. 
If yes, provide the date study coordinator took the Research Compliance Officer 
training course.  9/10/2020 
 
3. 
Does this project involve a designated Coordinating Center(s)?  Yes 
     No 
 
3.1. 
If yes, provide the name of the Coordinating Center(s) and contact information below. 
3.1.1. 
Name of Coordinating Center:  VACHS, West Haven campus   
3.1.2. 
Contact Name (Program Manager or other POC):  Jennifer Ibarra   
3.1.3. 
Phone Number:  203-932-5711 ext. 2431    Email address:  
jennifer.ibarra@va.gov   
 
 
SECTION 3:   PROJECT OVERVIEW 
1. 
What organization is funding this study?  (Check all that apply) 
 
 CSP         
 CSR&D      
 HSR&D      
 RR&D     
 BSLR&D  
 QUERI   
 
 VHA Central Office         
 Private Nonprofit: Please specify:        
 
 Department of Defense (DoD)    
 Commercial Sponsor: Please specify:       
 
 None; If none is checked, provide justification why there is no funding source.        
 
Funding Agency Project number:   HX002509-01A1    
 
2. 
What are the research questions or hypotheses to be studied?   
The purpose of this research study is to evaluate the feasibility of a full-scale efficacy 
randomized control trial (RCT) of SUMMIT, a multi-component web program designed to enable 
Veterans to safely taper opioids. 
 
The study will examine the feasibility of using the SUMMIT app in conjunction with a 
motivational interviewing session in opioid tapering, compared to only using an already 
established mobile application (Manage My Pain). 
 
We hypothesize that the proposed feasibility trial will support a future definitive large-scale trial.   
 
3. 
Describe the relevance to Veterans of studying the above questions or hypotheses and 
the importance of the knowledge this project is likely to generate: 
Veterans have approximately double the rate of opioid overdose compared with non Veterans. 
(3) Along with the myriad potential adverse events (AEs) associated with long-term opioid 
therapy (LTOT), mounting evidence suggests it has modest or absent benefit. The first 
pragmatic long-term randomized control trial (RCT) comparing an opioid-intensive to an opioid 
avoidant chronic pain management strategy found no improvement in chronic pain outcomes in 

CMCVAMC IRB Form 101 
 
      Page 5 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
Veterans and double the side effects at 12 months. Guidelines recommend tapering LTOT when 
harm outweighs benefit; observational data suggest improved quality of life among persons who 
successfully taper.  
 
While guidelines recommending against LTOT initiation should help prevent future harms, 
hundreds of thousands of Veterans currently on LTOT are left vulnerable as there are 
insufficient resources to help them taper and/or ultimately discontinue LTOT. To afford a safe, 
veteran-centered tapering strategy to those currently prescribed LTOT, programs must be 
developed to extend the reach of face-to-face encounters with health professionals. Thus, we 
are developing SUMMIT as an ancillary intervention to support, reinforce, and complement 
provider-initiated opioid tapering initiatives across the VHA. 
 
4. 
What research methods will be used in the project?  (Check all that apply) 
 Surveys/Questionnaires 
 Interviews             
 Audio Taping 
 Behavioral Observations 
 Chart Reviews     
 Video Taping 
 Focus Groups 
 Randomization 
 Double-Blind 
 Control Group 
 Placebo 
 Withhold/Delay Treatment 
 Specimen Collection 
 Deception 
 Other (Specify):       
 
5. 
Does the project involve usual care?  Yes 
      No 
 - If no, skip to question 6.  
5.1. 
If yes, answer the following additional questions: 
5.1.1. Who will provide the usual care, i.e., the study team or the participant's 
health care provider?        
5.1.2. Clearly differentiate what is usual care and what procedures and/or 
interventions are being performed solely for research purposes.  Indicate if 
usual care is limited to one arm of the study or if it is being delivered to all 
participants: 
 
                    Research procedures:        
 
                   Usual Care:         
 
6. 
Does this project involve international research?   Yes 
       No 
    
NOTE:  International research does not include studies in which VA is only one of multiple participating 
sites where the overall study-wide PI is not a VA investigator. 
 
7. 
Does this project involve collaborative research?   Yes 
 - See below   No 
  
7.1. 
If yes, delineate which research activities will be conducted as the VA portion of the 
overall collaborative research study: 
                  West Haven will only be particiapint in the data analysis. West Haven was the original 
site that had received funding. The implementation site for the study is the Philadelphia VA.  
 
NOTE:  Collaborative studies do not include studies conducted under a Cooperative Research and 
Development Agreement (CRADA) with pharmaceutical companies or other for-profit or non-
Federal partners. 

CMCVAMC IRB Form 101 
 
      Page 6 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
SECTION 4:  POTENTIAL RISK/BENEFIT ANALYSIS 
1. Indicate the potential risk level of the project:  (Minimal Risk is defined as “the probability and 
magnitude of harm or discomfort anticipated in the research are not greater in and of themselves 
than those ordinarily encountered in daily life or during the performance of routine physical or 
psychological examinations or tests.”) 
             
 Minimal           
 Greater than Minimal 
NOTE: The IRB will make the final risk level determination. 
 
2. What are the potential risks or harms for participants in this project?   
     (List in bullet or number format) 
• 
Psychological: The Veteran subjects may risk distress from considering opioid tapering. The 
study team will attempt to mitigate this risk through clear explanation of the study goals and 
risks prior to subject participation. 
• 
Social: There may be some stress regarding potential loss of confidentiality on the part of 
subjects that are part of the motivational interviewing, which the study team will attempt to 
mitigate. 
• 
Confidentiality and Privacy: There is some risk of confidentiality. Efforts by the study team will 
be made to minimize this risk by following protocols that will keep all research documentation 
secured.  
NOTE:  Risks or harms can be physical, psychological, financial, social, or legal. They may involve 
breaches of confidentiality and privacy.  Do not include the risks of usual care unless usual care 
is part of the research interventions being performed. 
 
3. What are the anticipated benefits, if any, to participants or to society from this project? 
(List in bullet or number format) 
• 
Participants may need less opioid medication to manage pain 
• 
Participants may experience improvement in overall functiniong. 
• 
Veterans may also not directly derive any benefit from participating in this research 
project. However, if this approach is effective, it could have tremendous benefits for 
society if adopted on a wide scale to help individuals effectively taper their opioid 
dosage. 
 
4. Briefly describe the procedures for the orderly withdrawal or termination  of subjects if this 
study  involves any medical therapy. N/A 
  
      
       
5. Will any of the following be administered to participants or will they be exposed?  
          
YES 
NO 
Ionizing Radiation 
 
 
Radioactive Materials 
 
 
 
6. Check one of the boxes below based on your study design and provide the references from 
the protocol for the information in the table: 
 
 Prospective  Study        
 Retrospective Study       
 Both   
 
NOTE:  If retrospective is checked, some of the below categories may not apply and can be marked as 
“Not applicable.” 
 
Safety Issues 
 
Reference the protocol 
page and section.  
If not referenced in the 
protocol, cite document 
type, page and section 
where it is referenced. 
What Safety Information is 
Collected  
N/A 
      

CMCVAMC IRB Form 101 
 
      Page 7 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
How will Safety Information 
be collected 
N/A 
      
Frequency of Safety Data 
Collection 
N/A 
      
Safety Conditions that Trigger 
Immediate Suspension of 
Research 
N/A 
      
Procedures to notify 
participants or PCP of 
findings affecting 
participants’ health or welfare 
Section 16, 10.1; 11.1; 
13.3 
      
Procedures to minimize risk 
Section 16 
      
 
Inclusion Criteria 
Section 16, 7.1 
      
 
Exclusion Criteria 
Section 16, 17.1 
      
 
 
7. Will an independent Data Safety Monitoring Board (DSMB) or a Data Monitoring 
Committee (DMC) monitor the project?     Yes 
     No 
   
7.1. 
If yes, provide a description of responsibilities to include frequency of meetings:   
                      
7.2. 
If no, provide the protocol section and/or page where the data safety and monitoring plan 
is described, to include statistical tests to be used for analyzing the safety data to 
determine if harm is occurring.  
The PI will be responsible for monitoring the study. All participants will be given 
anticipatory guidance on when to seek medical attention. In addition, participants will be 
asked to report to the study team any events they feel resulted from participation in the 
study. They can either present in person or call on the study team. Study staff will 
contact the participant to collect any information on the issue and then the PI will review 
and determine whether it is okay to proceed, further investigation is needed, or the 
participant should stop the study. The PI will review all report of adverse events within 
24 hours of their occurrence and on a monthly basis determine if a change in protocol is 
indicated due to the occurrence of adverse events.   
        
8. If the PI is not a clinician, is there an appropriately credentialed and privileged clinician         
who has been designated as a member of the study team to make required decisions to   
help protect the health of the subject, review data on adverse events, and report new          
findings?       Yes 
     No 
     N/A 
 
 
9. How will you manage information from participating sites that might be relevant to 
participant protection and describe how that information will be conveyed to the  IRB (i.e., 
reports of problems, interim results)?   
       Participating site (VACHS, West Haven campus) will not be involved in the collection of data. 
Any problems at VACHS such as theft, loss and unauthorized access of records, or evidence of 
harm will be reported immediately to the PO, ISO, and IRB. Data will be shared with the West 
Haven via through shared folder on the CHERP server.                                                                         
 
 
 
 

CMCVAMC IRB Form 101 
 
      Page 8 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
SECTION 5:  HUMAN PARTICIPANT INFORMATION 
NOTE:  A participant is considered “enrolled” at the time the consent is signed so this number should 
include an allowance for screen failures prior to randomization.  
 
1. 
How many participant records will be reviewed PRIOR to enrollment/consent occurring?  
Approximately 1,280 participants records will be reviewed. 
 
2. 
How many participants will be screened PRIOR to enrollment/consent occurring? 
Approximately 640 participants will be screened assuming 1 enrolled per 10 screened. 
 
3. 
How many participants will be enrolled (total number to include randomized and screen 
failures AFTER consent is obtained)? 
Up to 64 participants will be enrolled. 
3.1. 
Will all research activity be the same at all sites?  Yes 
     No 
     N/A 
 
3.2. 
If no, please describe the activity that is different or limited (For example; 2 sites will 
analyze data only, or, 1 site will consent and enroll all participants etc.):  Philadelphia site 
will consent and enroll all participants and both Philadelphia and West Haven sites will 
analyze data. 
 
4. 
Are there any further screening procedures after enrollment?  Yes 
     No 
 
4.1. 
If yes, describe:        
 
5. 
Are non-Veterans being enrolled?  NOTE:  This does not include non-Veterans enrolled at 
non-VA sites.     Yes 
     No 
 
5.1. 
If yes, provide justification.        
      NOTE: 
➢ Every non-Veteran should sign VA form 10-0483, Acknowledgement of the Notice 
of Privacy Practices (ANOP) 
➢ Once the ANOP is signed, the research study staff must send the non-Veteran's 
name to the CMCVAMC Privacy Officer via encrypted e-mail.  The signed ANOP 
must be kept in the research study binder. 
➢ If an oral informed consent is used, the NOP should be sent to the non-Veteran 
via postal mail.  In addition, the research study staff must write a Note-to-File that the 
NOP was sent to the non-Veteran. 
                
6. 
Does this project target a specific race, gender or ethnic group as participants?  
     Yes 
     No 
     
6.1. 
If yes, indicate which group and why this group is being targeted.   
               
 
7. 
What is the age range of participants?  (Check all that apply.) 
Neonates (See note below) 
 
Children Under 18 (See note 
below)  
 
Young Adults (18-21) 
 
Adults (22-65) 
 
Seniors (Over 65) 
 
       NOTE:   If neonates or children is checked, certification by the Medical Center Director will be 
required. Only minimal risk research may be performed with children.  Only non-invasive monitoring 
and/or prospective observational and retrospective record review studies that are minimal risk can 
be conducted in VA involving neonates. 
 
8. 
Does the project involve the potential enrollment of any of the following populations or 
categories of participants?  That is, are you targeting a specific group.  NOTE:  These 
populations must be checked “Yes” if they are not being excluded from the research. 

CMCVAMC IRB Form 101 
 
      Page 9 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
 
Yes        
No     N/A 
a.  Employees  
 
 
 
b.  Students at the VA or Penn 
 
 
 
c   Individuals with impaired decision-making capacity   
 
 
 
d.  Pregnant women (See below) 
 
 
 
e.  Economically and/or educationally disadvantaged persons 
 
 
 
f.   Prisoners  (See Below) 
 
 
 
g.  Illiterate, limited, or no English language proficiency 
 
 
 
h.  Terminally ill patients 
 
 
 
i.   Children (See Below) 
 
 
 
 
SECTION 6:  INFORMED CONSENT  
1. 
Will the study team obtain 
 information or 
 biospecimens for the purpose of 
screening, recruiting, or determining the eligibility of prospective subjects without the 
informed consent of the prospective subject or the prospective subject’s legally 
authorized representative (LAR)?        Yes 
 - See below       No 
   
1.1. 
If no, skip to question 2. 
1.2. 
If yes, check one or both of the below boxes if they apply to this study: 
1.2.1. 
 Information will be obtained through oral or written communication with the 
prospective subject or the subject’s LAR 
1.2.2. 
 Identifiable information or biospecimens will be obtained by accessing records 
or stored identifiable biospecimens. 
NOTE:  If either or both of the above boxes is checked an informed consent waiver request does not 
have to be submitted for this activity.  However, a request for a HIPAA waiver will still need to be 
submitted and informed consent obtained for any research interventions after eligibility is established. If 
neither box was checked, this activity will need to be included in a request for an informed consent 
waiver.  
 
2. 
Will the project involve requesting any waiver or alteration of the consent process or a 
waiver of documentation of consent for any part of the project? Yes 
 - See below  No 
   
2.1. 
If no, skip to question 3. 
2.2. 
If yes, check one or more of the following boxes and submit the applicable waiver 
request(s). 
 
 
An alteration of the informed consent process  NOTE:  If deception is involved this 
box should be checked. 
 
Waiver of informed consent for only a specific portion(s) of the study (not including 
recruitment).  Specify for what portion(s) of the study the request is being 
submitted:   
         
 
Waiver of documentation of informed consent. Specify for what portion(s) of the 
study the request is being submitted:    
          
 
3. 
Will documented informed consent be obtained from participants?      Yes 
   No 
   
3.1. 
If no, go to question 4. 
3.1.1. If yes, will there be the use of surrogate consent?   Yes 
    No 
   
3.1.2. If yes and this is a repository study, will a broad consent be used?  
       Yes 
      No 
   
 
NOTE:  Reference the CMCVAMC IRB Form 104 template, Combined ICD/HIPAA Authorization, and 
follow the instructions.  If planning to obtain surrogate consent, check applicable state and local laws to 
ensure compliance.  
 

CMCVAMC IRB Form 101 
 
      Page 10 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
4. 
Does the project involve photos, videos or voice recordings of a participant that are done 
for research purposes?         Yes 
      No 
     
4.1. 
If yes, this must be covered in the informed consent document (ICD), information sheets, 
telephone screen scripts) 
 
SECTION 7:  HIPAA AUTHORIZATION FOR PROJECT PARTICIPANTS 
NOTE:   Written HIPAA Authorization signed by the individual to whom the information or record 
pertains is required when VA health care facilities need to utilize individually-identifiable health 
information for a purpose other than treatment, payment, or health care operations, e.g., research. (VHA 
Handbook 1605.1).  
 
1. 
Check all of the following that apply if Protected Health Information (PHI) will be used.  If 
more than one box is checked, specify the part or phase of the study to which the 
specific checked boxes apply:  A project specific HIPAA Authorization combined with the 
informed consent document is to be used for enrollment of participants. Request for a HIPAA 
Waiver of Individual Authorization for recruitment purposes only is during reviewing and 
screening of participants records prior to enrollment. 
 
 
A project specific HIPAA Authorization is combined with the informed consent 
document.    
 
A separate project specific participant HIPAA Authorization form (VA Form 10-0493) 
is attached. NOTE: This is highly recommended when enrolling individuals with 
impaired decision making or with longitudinal studies requiring reconsent 
 
A request for a HIPAA Waiver of Individual Authorization is attached to cover the 
entire study.  
 
A request for a HIPAA Waiver of Individual Authorization for recruitment purposes 
only is attached. 
 
A request for a HIPAA Waiver of Individual Authorization is attached to cover a 
portion of the study.   Specify portion of study:          
 
2. 
Will the project require that participants authorize release of medical records or health 
information from non-VA sites?     
   Yes       
   No  
 
 
SECTION 8:  PARTICIPANT RECRUITMENT INFORMATION 
1. 
Describe the recruitment strategy for the just, fair, and equitable recruitment and 
selection of subjects, and reference recruitment procedures as cited in the protocol to 
include the following:  Step-by-step how recruitment will take place, i.e., obtaining names 
from CPRS or other databases, use of recruitment letters, referrals, posters, phone calls etc., to 
include any screening procedures prior to enrollment. Number steps or use bullets. 
1. Eligible participants on LTOT will be identified through the VA Corporate Data Warehouse 
(CDW).  
2. A focused electronic medical record (EMR) review will be conducted to determine 
inclusion/exclusion criteria.  
3. A list of eligible participants will be compiled into an Excel file and saved on the secured 
CHERP server.  
4. Eligible participants will be mailed a study letter informing them on the purpose of the study 
and how to opt out of being contacted if they’re not interested in being contacted. 
5. Those who do not opt out will be contacted by telephone. Five attempts will be made to 
make contact. 
6. In addition, potential participants may be informed about the study by their primary care 
provider and be provided with a study letter.  
NOTE: VA policy prohibits “cold calls” to potential VA research participants.  Initial contact must be 
made in person or by letter prior to making any telephone contact, unless there is written documentation 
that the subject is willing to be contacted by phone about the specific study or the specific kind of 

CMCVAMC IRB Form 101 
 
      Page 11 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
research.  The initial telephone contact must also provide a telephone number or other means for the 
potential participant to use to verify the study constitutes VA research (VHA Handbook 1200.05)  
 
2. 
Will the recruitment strategies described above be allowed to vary among sites? 
             Yes 
      No 
     N/A 
 
 
3. 
Are any model recruitment materials going to be made available?     Yes 
      No 
      
3.1. 
If yes, list all type of materials that will be used and indicate whether each type of 
material is being submitted with this application or whether it will be submitted later as an 
amendment.  If there will be telephone contact during the recruitment process, a 
script must be provided and listed below. 
 
Recruitment Material Type 
Included with Application 
Study Letter 
Yes  
      No  
   Will submit an amendment   
Telephone Script 
Yes  
      No  
   Will submit an amendment   
      
Yes  
      No  
   Will submit an amendment   
Additional rows can be added as required. 
NOTE: All recruitment materials must be reviewed and approved by the IRB prior to use as part of any 
recruitment activities.  All recruitment materials must include a statement that the study involves VA 
research and a telephone number or other means for the potential participant to use to verify that the 
study is VA research. 
 
SECTION 9:  PAYMENT TO PARTICIPANTS  
1. 
Will participants receive compensation in this study?          Yes 
        No 
      
(If no, skip this section and go to Section 10.) 
NOTE: If applicable, the method (and relative amounts) of payment should be the same at all 
participating sites whenever possible. Investigator will be asked to provide justification to the IRB for 
differences in method and/or relative amounts.  
 
2. 
Indicate the preferred method and mode of payment as follows:  
2.1. 
What form of payment will be used, i.e., check, voucher, gift card?   
Voucher 
2.2. 
What is the schedule of payments, i.e., one-time or after specific visits? 
$5 for bi-weekly surveys (up to 18 times over 9 months) and 
$25 for quarterly surveys (up to 4 times over 9 months) 
2.3. 
Provide the total amount for entire participation 
Up to $190 total 
 
3. 
Provide justification that the proposed payments are reasonable and commensurate with 
the  expected contributions of the participant to the project:   
The primary request for participants is completion of the surveys above, as study participation 
otherwise primarily involves making available a mobile application to use as desired, while 
participating in their usual care plan with their provider. As a result, we believe the propsed 
payments are reasonable and commensurate for the survey completion. 
 
4. 
Does the payment include transportation costs?   Yes 
      No 
      
4.1. 
If no, will transportation costs be paid separately? Yes 
      No 
   
4.2. 
If yes, explain  
      
 
5. 
Specify the source of payment: 
 CMCVAMC        
 Other (specify):           
 
6. 
Will a social security number (SSN) be requested and/or used in making 
payment/compensation?  Yes 
   No 
  

CMCVAMC IRB Form 101 
 
      Page 12 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
NOTE: If yes, be sure to include in the 'combined ICD/HIPAA' or the separate HIPAA authorization and 
informed consent the name of the organization making payment. 
 
SECTION 10:  BIOLOGICAL SPECIMENS 
1. 
Will biological specimens be used in this protocol?   Yes 
   No 
      
     (If no, skip this section and go to the next.)  
 
2. 
List the specimens that are being collected and indicate the purpose of the collection (one 
or both boxes may be checked.) 
Type of specimens 
Research Use 
Clinical Use 
      
 
 
      
 
 
Additional rows may be added as required. 
 
3. 
Respond to the following questions by checking the appropriate box:                             
                         
YES 
NO 
a. Does the project involve genetic testing?  If yes, see below: 
 
 
1) Does this include whole genome sequencing? 
 
 
2) Will participants be informed of the results of any DNA 
testing? 
 
 
b. Will specimens be kept for future use in other studies? If 
yes, see question 7 below. 
 
 
c. Will samples be made anonymous to maintain 
confidentiality?  NOTE:  Coding data is not considered 
making it anonymous. 
 
 
d. Will specimens be destroyed after the project-specific use is 
completed? 
 
 
e. Will specimens be used for commercial profit?  If yes, see 
below: 
 
 
1) If yes, will participants share in this commercial profit? 
 
 
f. Will participants be informed of the results of the specimen 
testing? 
 
 
g. Are there any implications for family members based on 
specimen testing results? (If yes, the family members may 
be participants.) 
 
 
 
4. 
Will specimens be de-identified?   Yes 
        No 
   
4.1. 
If yes, describe how the data will be de-identified, who will do it, and at what point in the 
process will the specimens be de-identified.         
 
5. 
What measures will be taken to minimize the potential for physical, psychological, 
financial, social, or legal harm from breaches of confidentiality and privacy resulting from 
unauthorized access to or loss of the specimens?            
 
6. 
Describe how the destruction of samples will be substantiated:        
 
7. 
If specimens are to be banked for future use in other studies, the following questions 
must be answered:     
 N/A 
7.1. 
Indicate where the specimens will be banked.   
                
7.2. 
If above is a VA location, what IRB is responsible for overseeing the operations of the 
tissue bank (i.e., local IRB or other multi-site IRB?).   
                    

CMCVAMC IRB Form 101 
 
      Page 13 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
NOTE:  If the bank is located at CMCVAMC, a Standard Operations Procedures (SOP) manual is 
required.  Contact one of the IRB Coordinators to obtain the SOP template. 
 
SECTION 11:  PRIVACY, CONFIDENTIALITY, AND INFORMATION SECURITY IN RESEARCH 
1. 
What type of data will be recorded/collected by the Principal Investigator study team?    
 
Check all that apply: 
 
   De-identified – Data does not contain any identifiers that could link the data to a specific 
participant.  (See VHA Handbook 1605.01, Appendix B, para 2b, for a list of identifiers that 
must be removed before data can be considered de-identified.  Data must be de-identified in 
accordance with HIPAA and Common Rule criteria.  Scrambling of names and social security 
numbers is not considered de-identified information.) 
 
 
   Identified – Data contains direct identifiers sufficient to identify participants as indicated in 
VHA Handbook 1605.01, Appendix B, para 2b.  ALL HIPAA IDENTIFIERS INCLUDING 
DATES. 
 
   Coded – Data linked to a specific subject by a code rather than a direct identifier.  While the 
data may contain some protected health information (PHI) only someone possessing the 
code can link the data to a particular participant.   
 
1.1. 
If coded data is checked, specify how the link or code will be maintained, and list each 
person/role who will have access to the link or code:     
Veteran’s protected health and personally identifiable information will be coded and 
securely stored in a file cabinet behind closed doors in CHERP Room B110. Identified 
and coded data will be kept in two separate file locations, both located in Room B110. 
Any electronic data will be kept on the secured CMCVAMC server vhaphicherpnas 
(//vhaphifpccherp.v04.med.va.gov\shares2\Chhabra_Manik). Any audio recordings from 
the Motivational Interviewing sessions will be uploaded same day onto a VA computer 
and audio files will be saved on the secured CMCVAMC server vhaphicherpnas 
(//vhaphifpccherp.v04.med.va.gov\shares2\Chhabra_Manik) and subsequently erased 
from the audio recorder.The code linking the identified/coded data will will be maintained 
in a separate, password protected file, stored electronically on the CHERP server and be 
accessible on ly to the PI. 
 
2. 
Indicate how the PHI will be obtained by checking one or more of the boxes below: 
 
  From existing sources such as medical records, clinical databases, or research 
records. 
 
If the above box is checked, specify each source and who maintains the database:  
Database Name 
Who Maintains the Database 
Corporate Data Warehouse 
VA 
CPRS Medical Charts 
VA 
 
 
 
 
Additional rows may be added as required. 
 
  Directly from project participants during protocol procedures as described elsewhere 
in this application or in the protocol.  
 
 
3. 
Check which of the following HIPAA identifiers will be collected and recorded during the 
course of the study: 

CMCVAMC IRB Form 101 
 
      Page 14 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
 Names 
 Social Security (or 
scrambled SSNs)/Medical 
record numbers 
 Device identifiers and serial 
numbers 
 E-mail addresses 
 IP Addresses (Internet 
Protocol 
 URLs (Universal Resource 
Locator) 
 All elements of dates 
(except year) and any age 
over 89 
Specify:   DOB 
 Health plan beneficiary 
numbers 
 All geographic subdivisions’ 
smaller than a state 
Specify:  City/zip code 
information will be collected to 
mail letters to potential 
participants 
 Telephone numbers 
 Account numbers 
  Biometric Identifiers 
including finger and voice print 
 Fax numbers 
 Certificate or license 
numbers 
 Full face photographic 
images and comparable images 
 Vehicle ID and serial 
numbers including license 
plate numbers 
 Other unique identifying 
number, characteristic, or code 
Specify:        
 HIV (testing or infectious 
disease) records 
 Sickle Cell Anemia 
 Drug Abuse Information 
 Alcoholism or Alcohol Use 
 
4. 
Will a non-VA entity have access to VA sensitive data?     Yes 
 - See below    No 
 
4.1. 
If yes, specify each entity and identify their roles in the study:    
 Name of Non-VA Entity 
Role in Study 
 
 
 
 
 
 
Additional rows may be added as required. 
 
4.2. 
If yes, will a copy of a Data Use Agreement (DUA) or a Cooperative Research and 
Development Agreement (CRADA) with this application? Yes 
     No 
    N/A 
NOTE:  If no, a DUA or CRADA must be provided to the IRB for review prior to initiation 
of any research procedures. 
 
5. 
List the study team members by title who will have access to the data. (Specify 
approximate number of personnel and their job categories, e.g., 2 Co-investigators, 4 Nurse 
Coordinators, etc.) 
1 Investigator, 1 co-investigator, 2 Collaborators (as listed in current staff form) 
 
6. 
Will specially obtained software be used?    Yes 
 - See below     No 
   
6.1. 
If yes, describe the software, the source of the software, whether a license will be 
required and who will fund the license, as well was any data that will be stored in 
temporary files on the computer’s hard drive.   
       
 
7. 
Will any web-based applications be used?    Yes 
 - See below   No 
         
7.1. 
If yes, identify the application and its security features.  Indicate how it will be used, e.g., 
for recruiting subjects, completing questionnaires, or processing data. 
The Manage My Pain app will be used for participants randomized to the control 
intervention. This app is freely available on both Android and iPhone operating systems. 
 
SUMMIT will be used for participants randomized to the experimental intervention. 
Both of these web-based applications will be used on their personal mobile phones that 
will not collect identifiable data but solely used as educational web-tools for the 
participants. 
 

CMCVAMC IRB Form 101 
 
      Page 15 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
The VA REDCap will be used for completion of participant questionnaires.  
 
VA HealtheDialog texting system (ANNIE) will be used to send participants text 
messages in regard to completing surveys and utilizing the SUMMIT application.  
 
8. 
How will electronic data and/or paper records be secured?  If data is being stored on a 
computer hard drive, indicate if it is encrypted per VA guidelines.  
Veteran’s protected health and personally identifiable information will be coded and securely 
stored in a file cabinet behind closed doors in CHERP Room B110. Identified and coded data 
will be kept in two separate file locations, both located in Room B110. Any electronic data will be 
kept on the secured CMCVAMC server vhaphicherpnas 
(//vhaphifpccherp.v04.med.va.gov\shares2\Chhabra_Manik). 
NOTE:  Electronic research records should be stored/secured on the Research and 
Development server (Z drive), MIRECC server, PADRECC server or CHERP server. 
 
9. 
Will mobile devices be used in the study, i.e., laptops, audio recorders?  Yes 
     No 
   
9.1. 
If yes, indicate that mobile devices will be encrypted and that the encryption is FIPS 140-
2 validated.   
An audio recorder that meets encryption level and is FIPS 140-2 validated will be used 
for the Motivational Interviewing sessions in the experimental arm. 
 
10. 
How will data be transmitted and/or shipped, and how will it be protected during 
transmission or shipping?    
N/A 
 
11. 
How will project research data be stored?  
11.1. Indicate precisely where data will be stored to include physical site, network 
location/server name, type of mobile storage device, building and room number etc.    
Veteran’s protected health and personally identifiable information will be coded and 
securely stored in a file cabinet behind closed doors in CHERP Room B110. Identified 
and coded data will be kept in two separate file locations, both located in Room B110. 
Any electronic data will be kept on the secured CMCVAMC server vhaphicherpnas 
(//vhaphifpccherp.v04.med.va.gov\shares2\Chhabra_Manik). Any audio recordings from 
the Motivational Interviewing sessions will be uploaded same day onto a VA computer 
and audio files will be saved on the secured CMCVAMC server vhaphicherpnas 
(//vhaphifpccherp.v04.med.va.gov\shares2\Chhabra_Manik) and subsequently erased 
from the audio recorder.  
NOTE:  If data will reside on a non-VA server or non-VA equipment, specify that the server is certified 
and accredited as required by the Federal Information Security Management Act of 2002 (FIMSA) and 
that the required permissions for use of a non-VA server have been obtained.  Contact the CMCVAMC 
Information System Security Officer (ISSO) for more information. 
 
11.2. If any of the 18 HIPAA identifiers (VA sensitive information) is being stored outside 
the protected VA environment, the following questions must be answered:  
  N/A 
11.2.1. How are the data being protected?  
       
11.2.2. Indicate what VA information will be returned to the VA, how the 
information will be returned, and/or the plans for its eventual destruction 
at the alternate non-VA site.  
           
11.2.3. Is there a Memorandum of Understanding (MOU) and/or a Data Use 
Agreement (DUA) in place regarding the transfer and storage of the data 
outside the VA environment?    
Yes 
        No 
      
a) If yes, specify and/or attach agreement.        

CMCVAMC IRB Form 101 
 
      Page 16 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
b) If no, indicate why not.           
 
12. 
How long will the research data be stored and describe how the data will be destroyed 
once the maximum retention period as specified by the VHA Records Control schedule or 
the indicated retention period, if longer, is met? 
All research data will be stored and secured throughout the study process and after completion 
of the study. No research data may be destroyed until after 6 years after study is completed in 
conjunction with discussion with research liaison.  
 
13. 
What is the plan for protecting project research data from improper use or disclosure?   
NOTE:  As part of the response to this question, indicate that removal of access to research 
study data will be accomplished for study personnel when they are no longer part of the 
research team.  Include that the ISO and Privacy Officer will be notified within one hour of the 
improper use or disclosure.     
Study staff will be the only ones who will have access to the project research data. In addition all 
data collected will be stored on the VA secure server. No data will leave the protected VA 
environment, thus no data will be returned to the VA as well. All records will be retained 
according to VA regulations. The removal of access to research study data will be accomplished 
for any study staff members that are no longer part of the research team. The ISO and Privacy 
Officer will be notified within one hour of the improper use or disclosure of project research data. 
 
14. 
Will a Certificate of Confidentiality (CoC) be obtained?    Yes 
       No 
     
14.1. If yes, include this information in the informed consent document (ICD). 
NOTE:  If this is a qualifying NIH Study, the CoC will be assumed.  A CoC helps investigators protect 
the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms 
of sensitive research. Certificates protect against compulsory legal demands, such as court orders and 
subpoenas, for identifying information or identifying characteristics of a research participant.  For more 
information on CoCs go to: http://grants.nih.gov/grants/policy/coc/.  
 
15. 
Will data be disclosed (copy given) outside of VHA?   Yes 
       No 
  
15.1. If yes, describe to whom the data are to be disclosed, the justification for such 
disclosure, and the authority for the disclosure, e.g., HIPAA authorization or VA Form 10-
5045, Request for and Authorization to Release Medical Records or Health Information. 
      
 
16. 
Will data be banked for re-use in future studies?      Yes 
 - See Below    No 
  
16.1. Where will the data be banked? 
16.1.1. Name of entity:                                         
16.1.2. Location:       
 
16.2. Is this an existing data repository with appropriate oversight mechanism per VHA 
Handbook 1200.12 or, if a non-VA entity, are the appropriate safeguards addressed 
in the CRADA or DUA?   Yes 
        No 
   
16.1.1. If no, indicate for VA entities that approval will be sought from the local IRB 
where the repository will be housed, whether a separate study or amendment 
will be submitted to the IRB for review for creation of the data repository, OR for 
non-VA sites, whether the CRADA or DUA is still being negotiated.     
      

CMCVAMC IRB Form 101 
 
      Page 17 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
SECTION 12:  FDA-REGULATED AND OTHER PRODUCTS 
1. 
Does the project require use of drugs, biologics, supplements, or devices? 
        Yes 
        No 
 - If no, skip to Section 13 
 
2. 
Indicate the type of clinical trial if applicable?        
    
  Phase I      
  Phase II     
  Phase III      
  Phase IV 
 
3. 
Does the project involve an Investigational New Drug Application (IND) or Investigational 
New Device Exemption (IDE), Abbreviated IDE, or IND Exception?     Yes 
      No 
  
3.1. 
If yes, attach a copy of any applicable correspondence with the FDA and complete the 
following: 
3.2. 
If applicable, indicate the name of the person or organization holding the IND or IDE. 
      
3.3. 
Is there a plan for onsite data monitoring?    Yes 
      No 
        
3.3.1. If yes, specify who will conduct monitoring responsibilities and how often.   
      
 
4. 
How will FDA-regulated products used in this study be dispensed and tracked to 
participating sites?  
      
 
5. 
If using FDA-regulated drugs or biologics, indicate use:   N/A 
 
 
Approved Drug(s) or Biologics For Approved Uses 
 
Approved Drug(s) or Biologics for Unapproved Uses (Use will be 
inconsistent with product labeling or involves a new use, labeling, 
advertising change, or a change in dose, dosage form, administration 
schedule, or recipient) 
 
6. 
List all drugs, biologics, or supplements to be used below.   N/A 
     
Generic Name 
Trade Name 
Manufacturer 
Use Consistent 
with Product 
Labeling? 
Yes/No 
IND 
Number if 
Applicable 
 
 
 
 
 
 
 
 
 
 
Add additional rows to table if necessary 
 
6.1. 
Is an Investigator’s Brochure included with the application materials?  Yes 
      No 
 
6.1.1. If no, indicate why?        
 
6.2. 
For all approved drugs used for an unapproved use, describe the unapproved use:
N/A   
      
 
6.3. 
If an IND is not required, explain and/or provide sponsor or FDA documentation:  
N/A  
      
 
7. 
If using FDA-regulated devices, indicate use:   N/A 
  
 
Approved Device(s) for an Approved Use 
 
Approved Device(s) for an Unapproved Use 
 
Other  (e.g., humanitarian use device; 510k clearance) Specify:       
 
8. 
List the FDA-regulated devices that will be used.    N/A 
  
Name 
Manufacturer 
Use Consistent 
w/ Product 
Labeling? 
Significant Risk (SR) 
or Non-significant 
IDE 
Number if 
Applicable 

CMCVAMC IRB Form 101 
 
      Page 18 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
Yes, No, or N/A 
Risk (NSR), 
Unknown, or N/A 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
8.1. Is manufacturer’s device information included with the application materials?  Yes 
    No 
 
 
8.2. If this is a non-significant risk device study, is documentation attached with the application 
materials explaining the manufacturer’s or a sponsor’s determination why the device is not a 
Significant Risk (SR) device ? (See 21 CFR 812)  Yes 
        No 
   
 
8.3. If applying for an IDE, is a copy of the dated IDE application letter to the FDA attached?   
Yes 
    No 
    N/A 
    
 
SECTION 13:  REQUEST FOR EXPEDITED REVIEW      
  
 
 Check if NOT requesting expedited review 
1. 
Check the below boxes as applicable for this study.  All three boxes must be checked in 
order for the study to qualify for expedited review: 
 
  The project presents no more than minimal risk to participants. 
 
  The identification of participants or their responses will not reasonably place them at risk of 
criminal or civil liability or be damaging to their financial standing, employability, insurability, 
reputation, or be stigmatizing, unless reasonable and appropriate protections will be 
implemented so that risks related to invasion of privacy and breach of confidentiality are no 
greater than minimal.  
 
   The project is not classified. 
 
2. 
If all three boxes are checked above, indicate one or more categories below for which this 
study would qualify for expedited review: 
 
  Category 1:  Clinical studies of drugs and medical devices only when one of the following 
conditions is met. 
 
  1a:  Research on drugs for which an investigational device exemption application (21 CFR 
Part 812) is not required. 
 
  1b:  Research on medical devices for which: 
(i) 
an investigational device exemption application (21 CFR Part 812) is not 
required; or 
(ii) 
the medical device is cleared/approved for marketing and the medical device is 
being used in accordance with its cleared/approved labeling. 
 
  Category 2:  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as 
follows: 
 
  2a:  From healthy, non-pregnant adults who weigh at least 110 pounds.  For these subjects, 
the amounts drawn may not exceed 550 ml in an 8-week period and collection may not 
occur more frequently than 2 times per week. 
 
  2b:  From other adults and children, considering the age, weight, and health of the subjects, 
the collection procedure, the amount of blood to be collected, and the frequency with 
which it will be collected.  For these subjects, the amount drawn may not exceed the 

CMCVAMC IRB Form 101 
 
      Page 19 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more 
frequently than 2 times per week. 
 
  Category 3:  Prospective collection of biological specimens for research purposes by 
noninvasive means. 
 
  Category 4:  Collection of data through noninvasive procedures (not involving general 
anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving 
x- rays or microwaves.  Where medical devices are employed, they must be cleared/approved 
for marketing. 
 
  Category 5:  Research involving materials (data, documents, records, or specimens) that have 
been collected, or will be collected solely for non-research purposes (such as medical treatment 
or diagnosis).  This category also includes research involving materials that were previously 
collected for either non-research or research purposes, provided that any materials collected for 
research were not collected for the currently proposed research. 
 
  Category 6:  Collection from voice, video, digital or image recordings made for research 
purposes. 
 
  Category 7:  Research on individual or group characteristics or behavior (including, but not 
limited to, research on perception, cognition, motivation, identity, language, communication, 
cultural beliefs or practices, and social behavior) or research employing survey, interview, oral 
history, focus group, program evaluation, human factors evaluation, or quality assurance 
methodologies.  
 
If the project does not fit into one of the above categories, it does not qualify for expedited 
review. 
 
 
 

CMCVAMC IRB Form 101 
 
      Page 20 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
SECTION 14: ABSTRACT 
1. Objectives(s):  The purpose of this study is to evaluate the feasibility of a full-scale efficacy 
randomized control trial (RCT) of SUMMIT (), a multi-component web program designed to enable 
Veterans to safely taper opioids.  
 
2. Research Design:  The study design is a 9-month, randomized, two-arm, parallel, open-label 
feasibility trial. Eligible participants will be randomized to a brief single Motivational Interview (MI) 
session and SUMMIT versus a pain monitoring app, Manage My Pain App. All participants will be 
provided a referral to speak with a clinical pharmacy specialist about their medications and options 
for tapering. Feasibility and outcomes planned for a full-scale RCT will be collected at one-, three-, 
six-, and nine-months post-intervention. Opioid dose and AEs will be collected biweekly. Given the 
urgency to develop effective programs to support tapering efforts, an interim analyses will be 
conducted at three months to evaluate trends in the recruitment rate, use of SUMMIT, and opioid 
dose reduction. If positive, results of these analyses will expedite the onset of the planned full-scale 
RCT.   
 
3. Methodology:  This study will target Veterans on long-term opioid treatment (LTOT) who will be 
identified using data available in the VA National Corporate Data Warehouse (CDW) and a focused 
electronic medical record (EMR) for Veterans who remain potentially eligible. Inclusion criteria for 
Veterans will be primary care patients who are dispensed ≥84 consecutive days of a stable dose of 
opioids (reflecting three consecutive 28-day prescriptions) or on buprenorphine through primary care 
and who report stable levels of pain intensity over the past month. Exclusion criteria will be Veterans 
on liquid methadone, have hearing or visual impairments (not corrected with hearing aids or glasses), 
psychiatric conditions, cognitive impairments, or participating in a concurrent pain or opioid-related 
research study. Up to 64 patients will be recruited to participate in Phase 2. The study visit with the 
participants will be conducted in a private area within the clinical care setting or in a research 
designated room at the CMCVAMC. After completing informed consent, participants will be trained 
how to electronically complete baseline assessments on their preferred device (i.e., tablet, smart 
phone, laptop). Afterwards, the patients will be randomly assigned to the intervention or control 
group.All participants will be provided a referral to speak with a clinical pharmacy specialist about 
their medications and options for tapering. The intervention arm will participate in a MI session lasting 
between 30 and 60 minutes, which will be audio recorded, and use SUMMIT. The participant will be 
registered into the VA HealtheDialog text messaging system to allow for surveys and the SUMMIT 
web application to be sent via text messages. The control arm will not participate in a MI session and 
will use the Manage My Pain app, which only includes a pain monitoring function. Opioid dose and 
AEs will be collected biweekly. Assessments will be completed electronically at one, three, six, and 
nine months post-randomization. A detailed report will be prepared of these findings.The team from 
the West Haven VA will be involved only in the data analysis of of the study data. 
 
4. Clinical relationships:  N/A  
 
5. Impact/Significance:  N/A 
 
 
 

CMCVAMC IRB Form 101 
 
      Page 21 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
SECTION 15: LIST OF ABBREVIATIONS 
Provide a list of all abbreviations used in the protocol and their associated meanings. 
1. LTOT – Long Term Opioid Therapy 
2. CDW – Corporate Data Warehouse 
3. EMR – Electronic Medial Record 
 
 
 

CMCVAMC IRB Form 101 
 
      Page 22 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
SECTION 16:  PROTOCOL SUMMARY 
1. 
Introduction 
1.1. Provide scientific background and rationale for study.   
Marked increases in opioid prescribing in the last 25 years have led to serious patient safety 
issues and modest or no benefit. Opioid prescribing quadrupled from 1990-2015. Meanwhile, 
rates of serious harms, some that typically occur acutely and some related to cumulative long-
term exposure, have increased.(1) the most catastrophic harm – overdose – has increased 5-fold 
since 1995 and is now the number one cause of accidental death in the u.s. by a large margin.(2) 
veterans have approximately double the rate of opioid overdose compared with non-veterans.(3) 
along with the myriad potential adverse events (aes) associated with long-term opioid therapy 
(LTOT), mounting evidence suggests it has modest or absent benefit. A cochrane meta-analysis 
of randomized and non-randomized studies lasting six months or longer in nearly 5000 
participants found only a small or modest benefit among study completers (representing ~30% of 
participants).(4) the first pragmatic, long-term randomized controlled trial (rct) comparing an 
opioid-intensive to an opioid avoidant chronic pain management strategy found no improvement 
in chronic pain outcomes in veterans and double the side effects at 12 months.(5) moreover, 
survey-based studies of veterans describe high levels of ambivalence about LTOT with fears 
about becoming dependent and complaints about waning benefit and feeling “drugged.”(6)  
 
Guidelines recommend tapering LTOT when harm outweighs benefit; observational data suggest 
improved quality of life (qol) among persons who successfully taper. In view of the evidence for 
harm and limited benefit of LTOT, both the centers for disease control and prevention and va/dod 
recently released guidelines for LTOT that stood out as marked departures from previous 
guidelines in that they both recommended avoiding initiation of LTOT.(7, 8) regarding persons 
currently on LTOT, both strongly recommended tapering or discontinuing opioids when harm 
outweighs benefit. Concurrently, the strongest evidence to date demonstrate no added benefit of 
LTOT in veterans with chronic pain(5) and observational studies demonstrate that patients who 
successfully taper experience improved qol and stable or even improved pain.(9-12) taking all 
these factors together, we assert that it is patient-centered and evidence-based to inform all 
patients on LTOT about the known harms and typically absent benefit of this therapy and to offer 
all patients on LTOT the opportunity to engage in a structured supportive tapering program.  
 
Despite the widespread calls for de-implementing LTOT, patient-centered methods of tapering or 
discontinuing opioid therapy are still needed. A recent systematic review found 62 studies of 
opioid tapering but only nine rcts.(13) benefits in pain severity, function and qol following opioid 
reduction or discontinuation were achieved; however, few of these interventions were conducted 
in primary care settings and all were of very low quality evidence. One subsequent rct of a 
physician assistant-led opioid tapering program compared to usual care among persons willing to 
taper found that the intervention group improved significantly more than the usual care group in 
self-reported pain interference, pain self-efficacy, and prescription opioid problems at 22 
weeks.(14) yet, there was no difference in the decrease in mean opioid dose across groups. In an 
evaluation of an organizational level implementation intervention to improve pain care quality over 
four years, the proportion of primary care patients on LTOT did not change, despite improvement 
in several other metrics of pain care quality.(15)          
 
1.2. Include summary of gaps in current knowledge, relevant data, and how the study will 
add to existing knowledge.   
1. Indirect data support the potential effectiveness of a patient-centered opioid tapering 
intervention. Qualitative and quality improvement data show that patients are willing to 
consider tapering if support is present. In our queri-funded qualitative study of barriers and 
facilitators to reductions in high-dose opioid therapy (as well as uptake of non-pharmacologic 
treatment), patients expressed frustration about perceived inadequate communication 
regarding the rationale for pain treatment plans; lack of their own and provider knowledge 
about tapering; and care fragmentation.(16) other va-based work revealed that patients view 

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the possibility of worsened pain and the system abandoning them as major barriers to 
initiating tapers.(17) they felt that having access to tailored information and timely follow up on 
treatment plans were important facilitators. Providers reported struggling to enhance patients’ 
motivation to engage with tapers and being daunted by the close and frequent follow-up that 
changes in pain treatment would entail. They discussed the availability of technology-
enhanced, collaborative care approaches as strong facilitators.  
 
2. An effective web-based program could be useful in variably resourced settings. In a needs 
assessment conducted for this study, primary care providers (pcps) and veterans noted that 
the main barrier to opioid tapering was the lack of resources available to veterans between 
outpatient visits. The goal of this proposal is to address this gap by developing SUMMIT,an 
interactive, theory-informed, multi-component mobile website program to enable veterans to 
safely taper opioids. To expedite implementation, as advised by the office of connected care, 
we propose to develop SUMMIT as a web-based program that can be accessed with 
anonymized login credentials, does not store personal health or identifying information, and 
does not interact with the va health record (akin to va ptsd coach). SUMMIT, if shown to be 
effective, would be useful in augmenting the effort of well-resourced facilities that can afford 
dedicated provider time to tapering. But in the more common scenario in which clinicians 
have little time to devote to tapering, SUMMIT could be used as an enhancement to usual 
care, modeled after a landmark study by tannenbaum et al.(18) in this study, older patients on 
long-term benzodiazepine treatment were mailed a detailed 8-page pamphlet that included 
safety-related reasons they should taper benzodiazepines and instructions on tapering. At six 
months, 27% of the intervention group had discontinued benzodiazepines compared with 5% 
of the control group. While this study demonstrates that people can taper medications with 
relatively minimal support, based on our qualitative results(16) and our experience caring for 
veterans on LTOT, we believe that additional motivation and support will be required to be 
successful.  
 
3. Intervention mapping (im) is a rigorous method of developing a multicomponent behavior 
intervention. Expert consensus recommends stepwise development of an intervention 
following a structured framework.(19) the widely-studied and applied im approach will serve 
as the framework for developing SUMMIT.(20) im was created to help health promoters 
develop the optimal intervention, based on planning, research, and theory, by creating a 
vocabulary for intervention planning, procedures for planning activities, and technical 
assistance with identifying theory-based determinants and methods for change. Im also 
provides a taxonomy of behavior change techniques (bcts) for use in supporting intervention 
content. In healthcare, im has been successfully applied to a wide range of different 
behaviors and populations.(21) particularly relevant to developing ehealth interventions, im 
lends itself to a user-centered design, which is essential to maximize acceptability, use, and 
adherence. We will use im to guide this proposal in two broad areas: (1) the identification of 
behavioral and environmental determinants related to opioid tapering, and (2) the selection of 
the most appropriate theoretical methods and practical applications to address the identified 
determinants.  
 
4. Web-based applications are effective. Web-based programs, requiring no, or SUMMITed 
(synchronous or asynchronous) person-to-person contact, can be effective in changing 
behaviors as well as in treating chronic conditions. A recent review found that web-based 
interventions decreased illicit substance use after treatment [hedges’ g (95% ci) = 0.31 (0.23 - 
0.39)] and after six to 12 months of follow-up [hedges’ g (95% ci) = 0.22 (0.07 - 0.37)].(22) a 
review of computerized interventions for depression and anxiety (common co-morbid 
conditions in veterans with chronic pain) commissioned by the va’s evidence-based synthesis 
program reported large post treatment effects for patients diagnosed with generalized anxiety 
(standardized mean difference (smd) = 0.94) and major depression (smd = 0.82) and 
moderate treatment effects for those with depressive symptoms without a confirmed 

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diagnosis of major depression (smd = 0.40).(23) of particular relevance to this proposal, 
several systematic reviews have confirmed that web-based programs are an effective adjunct 
to help patients manage chronic pain.(24-27) the most recent review found effect sizes 
(hedges' g) of -0.39 for pain interference, -0.33 for pain intensity, and -0.49 for 
catastrophizing.(28)  
 
5. Studies have found that multicomponent interventions are more effective than single 
component interventions.(29, 30) testing a multicomponent intervention “as a package”(31) 
will enable us to test the strongest possible program; however, this approach makes it difficult 
to understand the mechanism of action underlying any observed changes and does not 
provide a clear understanding of whether inclusion of all components is required to achieve 
the same benefit. To mitigate this limitation, we will follow best practices to enable future 
“deconstruction” of SUMMIT by: specifying the theoretical rationale for each bct; enumerating 
the specific theoretical constructs associated with each bct; classifying each bct according to 
the im taxonomy; measuring actual use of each component; supplementing quantitative 
measures with qualitative data to improve measures of actual use; and examining whether 
the amount of use of specific SUMMIT components is associated with change in specified 
theoretical constructs, and whether the latter mediate the relationship between treatment 
assignment and clinical outcome measures (see d.14.b and d.17.a).(31-36) 
 
6. Incorporating the right design features is important to maximize retention. Though there are 
several important advantages to web-based health interventions, including their ability to 
dramatically increase access, offer a menu of options that can be selected according to each 
individual veteran’s preferences, and tailor information based on individual user’s needs 
and/or performance, attrition is a well-documented and prevalent downside.(37) several 
strategies have been shown to decrease attrition. These include: choosing bcts based on 
relevant theoretical constructs,(38) tailoring information,(39) provision of feedback, social 
networking and support,(40, 41) and use of “nudges” or persuasive techniques.(42) in a 
recent detailed review of adherence to web-based interventions, “dialogue support” was 
found to be the principle persuasion technique influencing adherence.(43) in this context, 
dialogue support includes offering praise, rewarding targeted behaviors, use of system 
reminders or prompts, providing suggestions to help reach target behaviors, inclusion of 
content that reminds patients of themselves,(39) using an attractive design, and ensuring that 
the system acts in a social manner (for example as a coach or instructor).(43) feedback is an 
effective component of dialogue support and can be successfully delivered using automated 
systems.  
 
7. Motivating veterans to taper LTOT will be challenging. We acknowledge that motivating 
veterans on LTOT to taper will be difficult as many may be strongly biased to remain with the 
status quo. We will address this bias by including motivational interviewing (mi) as part of the 
intervention. Mi is a patient-centered approach that explores and develops patients’ 
motivation and commitment to change within a collaborative, highly empathic patient-provider 
relationship. Characteristically, providers blend a combination of fundamental patient-
centered counseling skills (e.g., reflective listening) with advanced strategic methods to elicit 
patient statements that favor change, called “change talk.” Trained counselors help the 
patient develop and appreciate discrepancies between important life goals and current 
behavior; thus, the motivation, while facilitated by the counselor, comes from the patient. Mi 
has been demonstrated to significantly increase patients’ intrinsic motivation for change and 
to increase self-efficacy for making behavioral changes across multiple conditions.(44-49) in 
this study, dr. Edmond (co-i) will conduct a single mi session with participants randomized to 
the intervention arm. The use of single session mi is supported by several studies.(50-53)  
 
8. Innovation: how our vision for SUMMIT differs from currently available pain apps. Robust pain 
self-management skills are critical to enable patients with chronic pain to optimize qol. In view 

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of this need, numerous web- and smartphone-based applications (apps) have been 
developed to increase competence and confidence is using these skills.(54, 55) while we 
recognize the value of these interventions, they are not designed to impact LTOT and 
therefore are unlikely to address the specific needs of veterans interested in tapering. Indeed, 
our qualitative work and preparatory interviews with patient-partners have emphasized the 
need to tailor the messaging and content of self-management strategies to issues relevant to 
LTOT. Based on the tannenbaum study cited above,(18) we infer that to impact behavior 
change with respect to opioid use, addressing the issue directly, clearly and transparently, as 
we propose to do in SUMMIT, will afford the highest likelihood of observing LTOT reductions. 
Thus, SUMMIT will differ from available apps in that 1) it will include approaches directly 
aimed at encouraging and supporting tapering, and 2) all self-management strategies 
included in the prototype will be tailored to the specific needs of those on LTOT. Phase 1 of 
the SUMMIT trial focused on development of the application; Phase 2 is focused on feasibility 
testing.  
 
9. Significance: while guidelines recommending against LTOT initiation should help prevent 
future harms, hundreds of thousands of veterans currently on LTOT are left vulnerable as 
there are insufficient resources to help them taper and/or ultimately discontinue LTOT. To 
afford a safe, veteran-centered tapering strategy to those currently prescribed LTOT, 
programs must be developed to extend the reach of face-to-face encounters with health 
professionals. Pcps, responsible for most of LTOT prescribing in VHA, are already 
overextended and spending additional time recommending and overseeing opioid tapers may 
be untenable. Thus, we are developing SUMMIT as an ancillary intervention to support, 
reinforce, and complement provider-initiated opioid tapering initiatives across the vha. To 
ensure rigor and successful future implementation, we will: 1) develop an evidence-based 
program with features proven to maximize engagement and retention; 2) ensure that the 
program includes mechanisms to address the diverse obstacles veterans report when 
consider opioid tapering (e.g., fear of pain flares and abandonment by the system); 3) employ 
a user-centered design process with meaningful input from veterans and pcps throughout the 
development and testing phases; and 4) adhere to recently published guidelines for mobile 
health interventions.(56) in addition, to ensure that SUMMIT is veteran-centered, veterans 
have played and will continue to play key roles in its development, testing, and execution. 
 
1.3. Include rationale for including or excluding certain populations – in particular 
vulnerable populations. 
Not Applicable 
 
2. 
Objectives 
2.1. 
Describe the study’s purpose, specific aims, or objectives.  
The purpose of this research study is to evaluate the feasibility of a full-scale 
efficacy randomized control trail (RCT) of SUMMIT), a multi-component web 
program designed to enable Veterans to safely taper opioids. 
 
2.2. 
State the hypotheses to be tested. 
We hypothesize that the proposed feasibility trial will support a future definitive 
large-scale trial. 
 
3. 
Resources and Personnel 
3.1. 
Include where and by whom the research will be conducted.  
The study will be conducted by the PI, at the CMCVAMC. Data analysis and support will 
be provided by the co-investigoars and collaborators at the West Haven VA. 
 
3.2. 
Provide a brief description of each individual’s role in the study.  Be sure to indicate 
who will have access to protected health information and who will be involved in 
recruiting subjects; obtaining informed consent; administering survey/interview 

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procedures; and performing data analysis. 
-The PI will have access to all study data, be involved with recruitment, obtaining informed 
consent and HIPAA authorization, and administering interviews. 
 
-The Co-Investigator and the collaborators will meet monthly with the PI to discuss study 
design and oversee study progress. The co-investigators and collaborators will be involved 
with data analysis and will not have access to PHI.  
 
-The research assistant, to be hired, will be involved with recruitment, obtaining informed 
consent and HIPAA authorization, and administering the initial study visit. 
 
3.3. 
If applicable provide information on any services that will be performed by 
contractors including what is being contracted out and with whom. 
N/A 
 
3.4. 
If applicable provide information on any Memoranda of Understandings (MOUs) or 
Data Use Agreements (DUAs) that are being entered into including with whom and 
for what reason. 
N/A 
 
4. 
Study Procedures 
4.1. 
Study Design 
4.1.1. 
Describe experimental design of the study.  Include sequential and/or parallel 
phases of the study, including durations, and explain which interventions are 
standard of care.   
The study design is a 9-month, randomized, 2-arm, parallel, open-label feasibility 
trial. Eligible participants will be randomized to a brief single Motivational 
Interviewing (MI) session and SUMMIT versus a pain monitoring app. All 
participants will also be provided a referral to speak with a clinical pharmacy 
specialist about their medications and options for tapering.Feasibility and outcomes 
planned for a full-scale RCT will be collected at one-, three-, six-, and nine-months 
post-randomization. Opioid dose and adverse events (AEs) will be collected bi-
weekly. We will send the link to the questionnaire to the participant if they have 
given permission to contact via email, otherwise we will send them the link via text, 
or read it aloud to them. Given the urgency to develop effective programs to 
support tapering efforts, we will perform interim analyses at three months. If 
positive, results of these analyses would expedite onset of the planned full-scale 
RCT. 
 
Eligible patients on long term opioid treatment (LTOT) or on buprenorphine will be 
identified through VA Corporate Data Warehouse (CDW). Receipt of opioid 
medication will be defined as any dispense of a VA formulary category CN101 
drug. Veterans having liquid methadone dispensed in the previous six months will 
be excluded. Because all methadone for the treatment of OUD is dispensed at 
federally licensed opioid treatment programs, we will cross check all methadone 
dispenses with stop code 523, the code used exclusively in those programs. For 
Veterans who remain eligible, a focused electronic medical record (EMR) review 
will be conducted to determine whether the Veteran is currently receiving liquid 
methadone or participating in a concurrent pain or opioid-related research study, 
and to check for evidence of hearing or visual impairments (not corrected with 
hearing aids or glasses), cognitive impairment or psychiatric condition. A list of 
eligible Veterans will be compiled into an Excel file and saved on the secured 
CHERP server. This list of potential subjects will NOT be printed out.  
 

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The study team will reach out via email to the primary care providers of Veterans 
who remain eligible after the above screening, to ensure the provider agrees with 
approaching the Veteran for possible enrollment. 
 
Approved Veterans  will then be mailed a letter informing them of the purpose of 
the study. The letter will notify potential participants that they will be telephoned by 
the project coordinator and will offer them the opportunity to refuse this contact by 
calling an answering machine and leaving a message. The project coordinator will 
telephone all patients who do not “opt out.” If someone other than the participant 
answers the telephone, no personal health information (PHI) will be shared with the 
person who answers. Five attempts will made be to make contact with the potential 
participants. Veterans may also be informed of the opportunity to participate in the 
study by their primary care provider and be provided with a study letter. The study 
team will contact the Veteran within a week of provision of study letter. Participants 
will be assured that their participation is voluntary and that they can opt out from 
participating. During the telephone call, the remaining eligibility criteria will be 
verified.  
 
Up to 64 patients will be recruited to participate in this research study. Due to 
COVID19, participants will undergo the informed consent process over the 
telephone, and provide oral consent.  
 
All participants will be offered a referral to a clinical pharmacy specialist in the pain 
clinic to discuss options for medication management and opioid tapering. As part of 
the informed consent, patients will be reassured that the tapering steps will be 
conducted by their own pain care provider or with the assistance of the clinical 
pharmacy specialist..After obtaining consent, participants will be trained on how to 
complete baseline and outcome measures on their preferred device. Surveys will 
be sent to the participant via email through RedCap. As an alternative, we 
will register participants into the VA HealtheDialog text messages system in 
order to receive surveys and access the SUMMIT web application via link.  
Baseline measures will be completed during this visit, prior to randomization, to 
ensure that participants are comfortable completing surveys electronically. 
 
Participants will be randomly assigned to the intervention or control group in a 1:1 
ratio in eight blocks of eight using the Research Electronic Data Capture (REDCap) 
Randomization Module.  
 
Randomization groups: 
Experimental Intervention: Participants randomized to the experimental intervention 
will participate in a Motivational Interviewing (MI) session lasting between 30 and 
60 minutes with a study coordinator. All MI sessions will be audiotaped using a VA-
approved digital recorder and transcribed verbatim. Participants will subsequently 
be shown how to access SUMMIT through a web link via a set of unique 
anonymized login credentials and to navigate the components of SUMMIT on one 
or more devices, depending on their preference. They will then be trained on how 
to complete the outcome surveyson RedCap, which will be sent via email .  
 
The SUMMIT application includes multiple modules for participants to learn about 
opioid tapering as well as other ways to manage their pain. As part of the 
application, participants will also have the option to connect with a peer support 
specialist at the VA who has previous experience with chronic pain and opioid 
tapering.  
 

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Control Intervention: Participants randomized to the control intervention will use an 
eHealth comparator: Manage My Pain(iPhone, Android). This app includes a pain 
monitoring functioning only, and thus will only minimally overlap, if at all, with 
SUMMIT’s components. Control participants will not participate in a MI session. 
Participants will download the app and be shown how to use the Manage My Pain 
app and trained how to complete the outcome surveys  
 
In order to help participants set up their mobile applications, the study coordinator 
will set up a video appointment through the VA’s virtual care manager (VCM) and 
using the VA video connect (VVC) software. The appointment is coordinated using 
the participants email address, and through the video appointment the coordinator 
will help the participant set up their device.   
 
 
 
 
4.1.2. 
Include a description of how anticipated risk will be minimized and include an 
analysis of risk vs. potential benefit. 
Veterans with anxiety or concerns will be referred to their primary care physician. 
Each Veteran will be assigned an ID number that is not related to any PHI. The key 
containing the link between the study ID number and participant will be maintained 
on the CMCVAMC’s secure server 
(\\vhaphifpccherp.v04.med.va.gov\shares2\Chhabra_Manik) on a separate folder 
from the collected data. Only Dr. Manik Chhabra (PI) and study staff will have 
access to this key. 
 
Neither the SUMMIT app nor the Manage My Pain app will be collecting any 
personal health information. The SUMMIT app will collect aggregated data on 
usage of features of the app. The Manage My Pain app once downloaded requires 
the user to complete an end user agreement that specificies how any collected 
data will be used and shared.  The app does aggregate non-personal information 
from all users, including pain records, age, geographic location, and gender, which 
is stripped of personal information. There is an option to sign up for an online 
account through the Manage My Pain app, which would collect additional 
information, however study participants will be advised not to do so. 
 
4.1.3. 
Provide description of the study population (delineate all categories of 
subjects – patients, providers, family members, employees, etc.). Include 
anticipated enrollment numbers. 
This projects involves the recruitment of 64 Veterans. Patient recruitment at the 
CMCVAMC will target male and female patients enrolled in long term opioid 
treatment (LTOT). 
 
4.1.4. 
As applicable, provide information on any added protections for vulnerable 
populations.  
N/A 
 
4.1.5. 
If applicable include information on data and specimen banking. 
N/A 
 
5. 
Recruitment Methods 
5.1. 
State how many subjects will be needed.  
64 subjects 
 
5.2. 
Describe when, where, how and by whom potential subjects will be identified and 
recruited.  
Eligible Veterans will be identified through data-base review of eligibility. The study team will 
reach out to the Veteran’s provider to ensure they agree with recruitment, and then the 

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Veteran willbe mailed a recruitment letter with study information and an invitation to 
participate. The letter will also notify potential participants that they will be telephoned by the 
project coordinator and will offer them the opportunity to refuse this contact by calling an 
answering machine and leaving a message. The project coordinator will telephone all 
patients who do not “opt out”. Five attempts will be made by telephone. During screening 
phone call, inclusion/exclusion criteria will be confirmed. Study visits will be scheduled same 
day as clinical appointments when possible. 
 
5.3. 
Describe materials that will be used to recruit subjects, e.g., advertisements.  
Include materials as an appendix or separate attachment 
A recruitment letter will be used, as noted above in 5.2. 
 
5.4. 
Describe any payments to subjects, including the amount, timing (at the end of the 
study or pro-rated for partial study participation), method (e.g., cash, check, gift 
card), and whether subjects will experience a delay in receiving the payment. 
Participants will be compensated $50 for the baseline questionnaire, $5 per biweekly 
survey (up to 18 times over 9 months) and $25 per quarterly survey (up to 4 times over 9 
months). Participants can be compensated up to $2400 total incentive. Patients will be 
paid via voucher or check from the VA. 
 
6. 
Informed Consent Procedures 
6.1. 
Indicate if informed consent will be obtained and/or if you are requesting a waiver of 
informed consent or waiver of documentation of informed consent.  If the research 
involves multiple phases, specify for which phases of the research the waiver(s) is 
being requested and/or the informed consent will be sought. 
Informed consent will be obtained. We will be obtaining an oral informed consent in part 
due to limitations as a result of COVID19. This is due to risks of obtaining in person 
consent for both patients and study staff. The patient will be contacted via telephone or VA 
Video Connect for the consent process, and the informed consent form will be read aloud 
to the participant to ensure full understanding of the purpose of the study, study 
procedures, as well as the risks and benefits of participating. Once the study coordinator 
confirms through questioning that the participant fully understands all aspects,oral consent 
will be documented. A copy will be mailed to the patient and be placed in the patient’s 
chart.  
 
6.2. 
Describe who will be obtaining informed consent, if applicable, and any 
circumstances that may need to be addressed (e.g. subjects with impaired decision 
making ability and the use of a legally authorized representative, etc.) 
Study staff, such as the PI or the project coordinator will obtain informed consent. 
 
6.3. 
If applicable, indicate how local site study personnel will be trained regarding 
human subjects' protections requirements and how to obtain and document 
informed consent. 
All study staff will be trained/overseen by PI. All study staff will have completed relevant 
training regarding human subjects protection and how to obtain informed consent. All 
personnel are required to have CITI (Good Clinical Practices and Ethical Principles), VA 
Privacy and Information Security Awareness and Rules of Behavior, and Privacy and 
HIPAA Trainings. In addition, all study staff obtaining informed consent will have taken the 
VA Research Compliance Officer training.  
 
7. 
Inclusion/Exclusion Criteria 
7.1. 
Describe the criteria that determine who will be included in or excluded from the 
study.  
Inclusion criteria for Veterans will be primary care patients who are dispensed ≥84 
consecutive days of a stable dose of opioids (reflecting three consecutive 28-day 

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prescriptions) through primary care and who report stable levels of pain intensity over the 
past month. Patients will also need to have a smartphone with the ability to download a 
mobile application. 
 
Exclusion criteria will be Veterans on liquid methadone or buprenorphine for opioid use 
disorder (OUD) and those who have transitioned to buprenorphine (transdermal or 
sublingual) for chronic pain, have hearing or visual impairments (not corrected with hearing 
aids or glasses), psychiatric conditions, cognitive impairments, or participating in a 
concurrent pain or opioid-related research study. 
 
8. 
Study Evaluations 
8.1. 
Describe all evaluations to be conducted (including screening; tests/questionnaires 
that will be administered; any procedures that subjects will be required to complete) 
and data collection methods.  Include materials as an appendix or separate 
attachment. 
The following questionnaires will be delivered through REDCap by the study coordinator at 
the outset of the study, and then every 6 weeks over the course of the study: Baseline 
Assessment, Daily Opioid Dose, Prescribed Opioids Difficulties Scale, PHQ-8, GAD-7, 
Modified Social Support Survey, Change Questionnaire, BIRS-24, PROMIS-29 Profile 
v2.0, and WHO 5-Item Well Being Scale. Participants will complete the surveys with the 
study coordinator, who will enter the responses intoREDCap. 
 
9. 
Data Analysis 
9.1. 
Provide sample size determination and analysis (include anticipated rate of screen 
failures, study discontinuations, lost to follow-up etc.). 
The calculated number of participants to be enrolled in this feasibility study was based on 
the approach outlined by Cocks and Torgerson (85), which recommends using a 1-sided 
confidence interval (CI) to determine whether it is worthwhile proceeding with a full-scale 
trial. If the proportion of participants achieving the primary outcome is 20% or lower in the 
control group (14), the sample size required to detect a difference of 15% in the main trial 
(assuming 80% power, alpha = 0.05, two-sided test) is 276. (14, 85) A pilot sample size of 
48 would produce a one-sided 90% CI that would exclude finding a 15% difference in the 
larger fully-powered trial. To account for the reasonably high drop-out rate, we will inflate 
the sample size by 25%. Thus, we will randomize 64 participants. 
 
9.2. 
Describe how, where and by whom the data will be analyzed. 
Quantitative statistics will be performed by SAS, version 9.4. and will be performed by Dr. 
Manik Chhabra (PI) and Dr. William Becker (co-I). As we are proposing a feasibility trial, 
most of the analyses are descriptive. We will use descriptive characteristics to describe the 
study population, all feasibility outcomes, and the distribution of the primary and secondary 
outcomes planned for the full-scale trial. We will ascertain the distributional characteristics, 
response rates as well as the percent of the missing data for all baseline and follow-up 
measures at each time point. Although not powered to detect significant between-group, 
we will compare differences in the primary and secondary outcomes to examine 
preliminary trends that may inform the design of the full-scale trial. We will use regression 
analyses to examine the association between group assignment and the primary and 
secondary outcomes. Group assignment and time will be modeled as fixed factors and 
participants as random factors. Separate models will be conducted for each outcome. We 
will perform an interim analysis at three months to evaluate trends in the recruitment rate, 
use of SUMMIT, and opioid dose reduction. These results may support earlier initiation of 
the planned full-scale RCT. Exploratory mediation analyses will be used to examine the 
processes underlying change. We will use the product of coefficients method to determine 
whether 1) “dose” (amount of use with specific SUMMIT components) and 2) change in 
specified theoretical constructs mediate the relationship between treatment assignment 

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and clinical outcome measures. (86) We will also examine the effect of compliance on 
change in theoretical constructs and the primary and secondary outcome measures using 
a Complier Average Causal Effect analysis. (87) To examine heterogeneity, exploratory 
moderating analyses will be performed by including an interaction term (moderator X 
intervention status) in a multiple linear regression model. We will construct separate 
models for the following five possible moderators: age, baseline opioid dose, duration of 
LTOT, prevalent comorbid mental illness, and baseline intrinsic motivation. Although we 
will not be sufficiently powered to perform definitive mediation or moderating analyses, the 
data generated from this feasibility study will determine which measures to include in the 
full-scale trial. 
 
10. 
Withdrawal of Subjects 
10.1. Describe any anticipated circumstances under which subjects will be withdrawn 
from the research without their consent.  
Subjects diagnosed with opioid use disorder (OUD) or substance use disorder (SUD) 
during the study will be withdrawn and referred for treatment. The studyteam will notify 
their PCP if this is the case. Subjects exhibiting inappropriate behavior online or with a 
peer specialist may also be withdrawn. 
 
10.2. Describe the consequences of a subject's decision to withdraw from the research 
and the procedures for orderly termination of participation by the subject (e.g., the 
subject contacting the investigator for an end-of-study visit). 
No consequences for withdrawal. Once we are notified of a participant’s decision to 
withdraw, we can continue to use information about them that has been collected up to 
that point. No information will be collected after a participant formally withdraws. 
11. 
Reporting 
11.1. Include procedures for reporting unanticipated problems, serious adverse events, 
and protocol deviations. 
Protocol deviations, unanticipated/unexpected problems will be reported to the IRB within 
5 business days of discovery. We will use the CMCVAMC serious-adverse event form for 
reporting SAEs, UADEs, and any other unanticipated/unexpected problems. We will also 
use the CMCVAMC Protocol Deviation form for reporting any protocol deviations. Any 
adverse event would be reported to the IRB at continuing review. Further, if the patient 
develops any concerns with their medication treatment plans, particularly effects related to 
their opioid tapers, these will be referred to their PCP. 
 
12. 
Privacy and Confidentiality 
12.1. Describe whether the study will use or disclose subjects’ Protected Health 
Information (PHI).  
For Veterans, we will need to obtain name, date of birth, complete mailing address, race, 
gender, and medical history. This information will be used only in our analysis and to 
contact the Veteran (mailing address); no information will be disclosed to others outside 
our study team.The applications being used by the study, likewise, will not use or disclose 
the participants PHI. 
 
12.2. Describe the steps that will be taken to secure the data (e.g., training, authorization 
of access, password protection, encryption, physical controls, Certificates of 
Confidentiality, and separation of identifiers and data) 
All study personnel will complete the required human subjects, HIPAA, and information 
security and privacy trainings at the VA. All paper/hard copy data, which includes subject 
log, informed consent forms, HIPAA authorization forms, and surveys will be maintained in 
study binders. The study binders in CMCVAMC will be kept in CHERP, 4100 Chester Ave, 
Suite 202 in a locked file cabinet. Any electronic data, which includes the subject log and 
the key linking participants to their ID number at CMCVAMC will be kept on the secured 
CMCVAMC server vhaphicherpnas (\\vhaphifpccherp.v04. 

CMCVAMC IRB Form 101 
 
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med.va.gov\shares2\Chhabra_Manik). The log and the key will be kept in separate folders 
on the server and will NOT be printed out. Study personnel with access to study data and 
who are no longer involved with the study will have access revoked and will be removed 
from the research staff form. 
 
13. 
Communication Plan for Multi-Site Studies or Studies being done at Non-CMCVAMC 
Locations    
  N/A; skip to question 14 
13.1. Include plan for ensuring all required local site approvals are obtained and notifying 
the Director of any facility where the research in being conducted but the facility is 
not engaged. 
All current documentation of VA IRB approvals will be stored in the VA secure server 
(\\vhaphifpccherp.v04.med.va.gov\shares2\Chhabra_Manik) and Dr. William Becker from 
the West Haven VA will upload any local site approval documents. 
 
13.2. Include plan for keeping all engaged sites informed of changes to the protocol, 
informed consent, and HIPAA authorization. 
Monthly team meetings will be held with the PI and study staff to discuss the study 
progress (including any changes to the protocol, informed consent, and HIPAA 
authorization).  
 
13.3. Include plan for informing local sites of any Serious Adverse Events, Unanticipated 
Problems, or interim results that may impact conduct of the study. 
Any SAEs, Unanticipated Problems or interim results that may impact conduct of the study 
will be immediately discussed with the other study site (West Haven VA) and reported to 
the CMCVAMC IRB within 5 business days of discovery. We will use the CMCVAMC 
serious-adverse event form for reporting SAEs, UADEs, and any other 
unanticipated/unexpected problems. We will also use the CMCVAMC Protocol Deviation 
form for reporting any protocol deviations. Any adverse event would be reported to the IRB 
at continuing review. 
 
13.4. Include plan for ensuring the study is conducted according to the IRB-approved 
protocol. 
As mentioned above (13.2), monthly team meetings will be held with the PI and study staff 
to discuss the study progress which help to ensure the study is being conducted according 
to the IRB-approved protocol. 
 
13.5. Include plan for notifying all local facility directors and LSIs when a multi-site study 
reaches the point that it no longer requires engagement of the local facility (e.g., all 
subsequent follow-up of subjects will be performed by the PI from another facility). 
Once the study concludes at the local facility (Philadelphia) – there will not be any 
additional follow-up of subjects from another facility (West Haven facility). Only data 
analysis will be occurring at the West Haven VA site after data collection has been 
completed at the Philadelphia VA. 
 
14. 
References (bibliography of cited literature) 
1. Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, et al. The effectiveness and risks 
of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health 
Pathways to Prevention Workshop. Annals of internal medicine. 2015;162(4):276-86. 
2. Rudd RA, Aleshire N, Zibbell JE, Matthew Gladden R. Increases in drug and opioid overdose 
deaths—United States, 2000–2014. American Journal of Transplantation. 2016;16(4):1323-7. 
3. Bohnert AS, Ilgen MA, Galea S, McCarthy JF, Blow FC. Accidental poisoning mortality among patients 
in the Department of Veterans Affairs Health System. Medical care. 2011;49(4):393-6. 
4. Noble M, Treadwell JR, Tregear SJ, Coates VH, Wiffen PJ, Akafomo C, et al. Long-term opioid 
management for chronic noncancer pain. Cochrane Database Syst Rev. 2010;1(1). 

CMCVAMC IRB Form 101 
 
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Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
5. Krebs EE, Noorbaloochi S, Bair MJ, Gravely A, Jensen AC, Kroenke K. Effectiveness of opioid 
therapy versus non-opioid medication therapy for chronic back and osteoarthritis painover 12 months: A 
pragmatic randomized trial.  Society of General Internal Medicine National Meeting; April 21, 2017; 
Washington, DC2017. 
6. Merrill JO, Von Korff M, Banta-Green CJ, Sullivan MD, Saunders KW, Campbell CI, et al. Prescribed 
opioid difficulties, depression and opioid dose among chronic opioid therapy patients. General hospital 
psychiatry. 2012;34(6):581-7. 
7. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United 
States, 2016. Jama. 2016;315(15):1624-45. 
8. The Opioid Therapy for Chronic Pain Work Group. VA/DoD CLINICAL PRACTICE GUIDELINE FOR 
OPIOID THERAPY FOR CHRONIC PAIN. 2017. 
9. Daitch J, Frey M, Silver D, Mitnick C, Daitch D, Pergolizzi J. Conversion of chronic pain patients from 
full-opioid agonists to sublingual buprenorphine. Pain Physician. 2012;15(3 suppl):ES59-ES66. 
10. Daitch D, Daitch J, Novinson D, Frey M, Mitnick C, Pergolizzi J. Conversion from High‐Dose Full‐
Opioid Agonists to Sublingual Buprenorphine Reduces Pain Scores and Improves Quality of Life for 
Chronic Pain Patients. Pain Medicine. 2014;15(12):2087-94. 
11. Hooten WM, Mantilla CB, Sandroni P, Townsend CO. Associations between heat pain perception 
and opioid dose among patients with chronic pain undergoing opioid tapering. Pain Medicine. 
2010;11(11):1587-98. 
12. Cunningham JL, Evans MM, King SM, Gehin JM, Loukianova LL. Opioid tapering in fibromyalgia 
patients: experience from an interdisciplinary pain rehabilitation program. Pain Medicine. 2016:pnv079. 
13. Frank JW, Lovejoy TI, Becker WC, Morasco BJ, Koenig CJ, Hoffecker L, et al. Patient Outcomes in 
Dose Reduction or Discontinuation of Long-Term Opioid Therapy: A Systematic Review. Annals of 
Internal Medicine. 2017;Revise and Resubmit. 
14. Sullivan MD, Turner JA, DiLodovico C, D'Appollonio A, Stephens K, Chan Y-F. Prescription Opioid 
Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. The Journal of Pain. 
2017;18(3):308-18. 
15. Dorflinger L, Moore B, Goulet J, Becker W, Heapy AA, Sellinger JJ, et al. A partnered approach to 
opioid management, guideline concordant care and the stepped care model of pain management. 
Journal of general internal medicine. 2014;29 Suppl 4:870-6. 
16. Becker WC, Dorflinger L, Edmond SN, Islam L, Heapy AA, Fraenkel L. Barriers and facilitators to use 
of non-pharmacological treatments in chronic pain. BMC Family Practice. 2017;18(1):41. 
17. Frank JW, Levy C, Matlock DD, Calcaterra SL, Mueller SR, Koester S, et al. Patients’ perspectives 
on tapering of chronic opioid therapy: A qualitative study. Pain Medicine. 2016;17(10):1838-47. 
18. Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of Inappropriate 
Benzodiazepine Prescriptions Among Older Adults Through Direct Patient Education: The EMPOWER 
Cluster Randomized Trial. JAMA Internal Medicine. 2014. 
19. Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior 
change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international 
consensus for the reporting of behavior change interventions. Annals of behavioral medicine. 
2013;46(1):81-95. 
20. Bartholomew LK, Parcel GS, Kok G. Intervention mapping: a process for developing theory and 
evidence-based health education programs. Health Education & Behavior. 1998;25(5):545-63. 
21. Eldredge LKB, Markham CM, Kok G, Ruiter RA, Parcel GS. Planning health promotion programs: an 
intervention mapping approach: John Wiley & Sons; 2016. 
22. Boumparis N, Karyotaki E, Schaub MP, Cuijpers P, Riper H. Internet interventions for adult illicit 
substance users: a meta-analysis. Addiction (Abingdon, England). 2017;112(9):1521-32. 
23. Dedert E, McDuffie JR, Swinkels C, Shaw R, Fulton J, Allen KD, et al. VA Evidence-based Synthesis 
Program Reports.  Computerized Cognitive Behavioral Therapy for Adults with Depressive or Anxiety 
Disorders. Washington (DC): Department of Veterans Affairs (US); 2013. 
24. Bender JL, Radhakrishnan A, Diorio C, Englesakis M, Jadad AR. Can pain be managed through the 
Internet? A systematic review of randomized controlled trials. Pain. 2011;152(8):1740-50. 

CMCVAMC IRB Form 101 
 
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HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
25. Eccleston C, Fisher E, Craig L, Duggan GB, Rosser BA, Keogh E. Psychological therapies (Internet-
delivered) for the management of chronic pain in adults. Cochrane Database Syst Rev. 
2014(2):Cd010152. 
26. El-Metwally A. Internet-based interventions for pain management: A systematic review of randomised 
controlled trial conducted from 2010 to 2014. . J Public Health Epidemiol. 2015;7:170-82. 
27. Macea DD, Gajos K, Daglia Calil YA, Fregni F. The efficacy of Web-based cognitive behavioral 
interventions for chronic pain: a systematic review and meta-analysis. The journal of pain : official journal 
of the American Pain Society. 2010;11(10):917-29. 
28. Buhrman M, Gordh T, Andersson G. Internet interventions for chronic pain including headache: A 
systematic review. Internet Interventions. 2016;4(Part 1):17-34. 
29. Martín Cantera C, Puigdomènech E, Ballvé JL, Arias OL, Clemente L, Casas R, et al. Effectiveness 
of multicomponent interventions in primary healthcare settings to promote continuous smoking cessation 
in adults: a systematic review. BMJ Open. 2015;5(10). 
30. Schoeppe S, Alley S, Van Lippevelde W, Bray NA, Williams SL, Duncan MJ, et al. Efficacy of 
interventions that use apps to improve diet, physical activity and sedentary behaviour: a systematic 
review. International Journal of Behavioral Nutrition and Physical Activity. 2016;13(1):127. 
31. Tate DF, Lytle LA, Sherwood NE, Haire-Joshu D, Matheson D, Moore SM, et al. Deconstructing 
interventions: approaches to studying behavior change techniques across obesity interventions. 
Translational Behavioral Medicine. 2016;6(2):236-43. 
32. Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of 
public health interventions. Annual review of public health. 2010;31:399-418. 
33. Bartholomew LK, Mullen PD. Five roles for using theory and evidence in the design and testing of 
behavior change interventions. Journal of public health dentistry. 2011;71 Suppl 1:S20-33. 
34. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating 
complex interventions: the new Medical Research Council guidance. BMJ (Clinical research ed). 
2008;337:a1655. 
35. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, et al. Designing and 
evaluating complex interventions to improve health care. BMJ (Clinical research ed). 
2007;334(7591):455-9. 
36. 
Kok G, Gottlieb NH, Peters G-JY, Mullen PD, Parcel GS, Ruiter RAC, et al. A taxonomy of 
behaviour change methods: an Intervention Mapping approach. Health Psychology Review. 
2016;10(3):297-312. 
37. Eysenbach G. The law of attrition. Journal of medical Internet research. 2005;7(1):e11. 
38. Webb TL, Joseph J, Yardley L, Michie S. Using the internet to promote health behavior change: a 
systematic review and meta-analysis of the impact of theoretical basis, use of behavior change 
techniques, and mode of delivery on efficacy. Journal of medical Internet research. 2010;12(1):e4. 
39. Strecher VJ, McClure J, Alexander G, Chakraborty B, Nair V, Konkel J, et al. The role of engagement 
in a tailored web-based smoking cessation program: randomized controlled trial. Journal of medical 
Internet research. 2008;10(5):e36. 
40. Richardson CR, Buis LR, Janney AW, Goodrich DE, Sen A, Hess ML, et al. An online community 
improves adherence in an internet-mediated walking program. Part 1: results of a randomized controlled 
trial. Journal of medical Internet research. 2010;12(4):e71. 
41. Stoddard JL, Augustson EM, Moser RP. Effect of adding a virtual community (bulletin board) to 
smokefree.gov: randomized controlled trial. Journal of medical Internet research. 2008;10(5):e53. 
42. Hutchesson MJ, Rollo ME, Krukowski R, Ells L, Harvey J, Morgan PJ, et al. eHealth interventions for 
the prevention and treatment of overweight and obesity in adults: a systematic review with meta-
analysis. Obesity Reviews. 2015;16(5):376-92. 
43. Kelders SM, Kok RN, Ossebaard HC, Van Gemert-Pijnen JE. Persuasive System Design Does 
Matter: A Systematic Review of Adherence to Web-Based Interventions. Journal of medical Internet 
research. 2012;14(6):e152. 
44. Romano M, Peters L. Understanding the process of motivational interviewing: A review of the 
relational and technical hypotheses. Psychotherapy research : journal of the Society for Psychotherapy 
Research. 2016;26(2):220-40. 

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45. Saitz R, Sullivan LM, Samet JH. Training community-based clinicians in screening and brief 
intervention for substance abuse problems: Translating evidence into practice. Substance Abuse. 
2000;21(1):21-31. 
46. Broers S, Smets E, Bindels P, Evertsz FB, Calff M, de Haes H. Training general practitioners in 
behavior change counseling to improve asthma medication adherence. Patient Education and 
Counseling. 2005;58(3):279-87. 
47. Velasquez MM, Hecht J, Quinn VP, Emmons KM, DiClemente CC, Dolan-Mullen P. Application of 
motivational interviewing to prenatal smoking cessation: training and implementation issues. Tobacco 
Control. 2000;9(suppl 3):iii36-iii40. 
48. Pakpour AH, Modabbernia A, Lin CY, Saffari M, Ahmadzad Asl M, Webb TL. Promoting medication 
adherence among patients with bipolar disorder: a multicenter randomized controlled trial of a 
multifaceted intervention. Psychological medicine. 2017:1-12. 
49. Hedegaard U, Kjeldsen LJ, Pottegard A, Bak S, Hallas J. Multifaceted intervention including 
motivational interviewing to support medication adherence after stroke/transient ischemic attack: a 
randomized trial. Cerebrovascular diseases extra. 2014;4(3):221-34. 
50. D'Onofrio G, Fiellin DA, Pantalon MV, Chawarski MC, Owens PH, Degutis LC, et al. A brief 
intervention reduces hazardous and harmful drinking in emergency department patients. Annals of 
Emergency Medicine. 2012;60(2):181-92. 
51. Edelman EJ, Dinh A, Radulescu R, Lurie B, D'Onofrio G, Tetrault JM, et al. Combining Rapid HIV 
Testing and a Brief Alcohol Intervention in Young Unhealthy Drinkers in the Emergency Department: A 
Pilot Study. The American Journal of Drug and Alcohol Abuse. 2012;38(6):539-43. 
52. D'Onofrio G, Pantalon MV, Degutis LC, Fiellin DA, Busch SH, Chawarski MC, et al. Brief intervention 
for hazardous and harmful drinkers in the emergency department. Annals of Emergency Medicine. 
2008;51(6):742-50. e2. 
53. McCambridge J, Strang J. The efficacy of single-session motivational interviewing in reducing drug 
consumption and perceptions of drug-related risk and harm among young people: results from a multi-
site cluster randomized trial. Addiction (Abingdon, England). 2004;99(1):39-52. 
54. Reynoldson C, Stones C, Allsop M, Gardner P, Bennett MI, Closs SJ, et al. Assessing the Quality 
and Usability of Smartphone Apps for Pain Self‐Management. Pain Medicine. 2014;15(6):898-909. 
55. Irvine AB, Russell H, Manocchia M, Mino DE, Glassen TC, Morgan R, et al. Mobile-web app to self-
manage low back pain: randomized controlled trial. Journal of medical Internet research. 2015;17(1):e1. 
56. Agarwal S, LeFevre AE, Lee J, L’Engle K, Mehl G, Sinha C, et al. Guidelines for reporting of health 
interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) 
checklist. BMJ (Clinical research ed). 2016;352. 
57. Moore BA, Fazzino T, Barry DT, Fiellin DA, Cutter CJ, Schottenfeld RS, et al. The Recovery Line: A 
pilot trial of automated, telephone-based treatment for continued drug use in methadone maintenance. 
Journal of substance abuse treatment. 2013;45(1):63-9. 
 
SECTION 17: KEYWORDS  
 
(NOTE:  Provide three (3) keywords.  Use MeSH Headings only (Central Office Requirement).               
Enter one item per line. http://www.nlm.nih.gov/mesh/MBrowser.html) 
1. Long Term Opioid Use Disorder 
2. Opioid Tapering Web-Tool 
3. Motivational Interviewing 
 
SECTION 18: INSTITUTIONAL SUPPORT 
 
(NOTE:  If yes is marked next to any Service/Section listed below, you MUST obtain the signature of the 
Service Chief or Designee of any Service/Section involved in research.  OR, a letter/e-mail should be 
provided to the investigator from the Service Chief or Designee of any Service/Section involved in this 
research.) 
 
Laboratory  
Yes 
  No 
 
 

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Signature OR Letter/E-mail   
Pharmacy 
Yes 
  No 
 
 
Signature OR Letter/E-mail   
Nuclear Medicine 
Yes 
  No 
 
 
Signature OR Letter/E-mail   
Psychiatry 
Yes 
  No 
 
 
Signature OR Letter/E-mail   
Medicine: David Stern 
Yes 
  No 
 
 
Signature on hard copy in IRB 1 Office/emd 
  
Radiology 
Yes 
  No 
 
 
Signature OR Letter/E-mail   
Nursing 
Yes 
  No 
 
 
Signature OR Letter/E-mail   
Outpatient 
Yes 
  No 
 
 
Signature OR Letter/E-mail   
Union 
Yes 
  No 
 
 
Signature OR Letter/E-mail   
Lab Space 
Yes 
  No 
 
 
Signature OR Letter/E-mail   
Other, specify       
Yes 
  No 
 
 
Signature OR Letter/E-mail   
 
SECTION 19: DATA MANAGEMENT AND ACCESS PLAN (DMAP)  
 
NOTE:  This Data Management and Access Plan (DMAP) should be used for Unfunded VA Research 
or VA Research Funded by Entities Without a Specific DMAP.   
IF THE FUNDING AGENCY HAS A DMAP, SUBMIT IT, INSTEAD OF THE BELOW. 
Section 1 - Funding – (Check applicable box and indicate funding source if present.) 
 VHA Program Office without Specified DMAP Format 
Name of Program Office:  VA HSR&D 
 External Funder without Specified DMAP Format 
Name of Funder:   
 Unfunded 
 Not applicable; see separate DMAP from funding source 
Section 2 - Public Access to Publications Resulting from the Research - (Check all applicable boxes.) 
  The proposed research is to be funded by VA. Publications resulting from the research will be 
made available to the public through the National Library of Medicine (NLM) PubMed Central 
website within one year after the date of publication.  [Submission procedures are provided on the 
Office of Research and Development (ORD) website at 
http://www.research.va.gov/resources/policies/public_access.cfm.] 
  The proposed research will not be funded by VA. 
  Publications will be made available to the public through PubMed Central within one year after the 
date of publication.  [See ORD website noted above.] 
  Publications will be made available to the public in another way. [Briefly describe plans below.]  
  Publications will not be made available to the public.  [Provide a brief rationale below.] 
Additional details related to plans for public access to publications results from the research, as 
indicated in section 2 above. 
 
Section 3 - Public Access to Final Data Sets Underlying Publications Resulting from the Research - 
(Check all applicable boxes.) 
  Final data sets underlying publications resulting from the proposed research will be shared outside 
VA in electronic format through the mechanism(s) indicated in Items #6 through #10 below. 

CMCVAMC IRB Form 101 
 
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  Final data sets underlying publications resulting from the proposed research will be shared outside 
VA ONLY in hard copy through the mechanism(s) indicated in Items #6 through #10 below. [Provide 
a brief rationale below]. 
  Final data sets underlying publications resulting from the proposed research will not be shared 
outside VA, except as required under the Freedom of Information Act (FOIA) [Provide the rationale 
below.] 
Additional rationale(s) for plans to access data sets underlying publications, as indicated in 
Section 3 above.   
 
Section 4 - Mechanisms for Public Access to Final Data Sets Underlying Publications Resulting from the 
Research – (Check all applicable boxes.) 
  As indicated in Item #5 above, final data sets underlying publications resulting from the proposed 
research will not be shared outside VA. 
  The project involves basic science research. Final data sets underlying publications resulting from 
such research will be shared as described in the space below.  [Describe mechanisms for sharing, 
e.g., upon request, through a databank or repository, via a website] 
The research involves 
human subjects. Data 
sets based on information 
obtained from human 
subjects will be shared as 
follows.  Check 
appropriate box.  
 
 
 
   Individually Identifiable Data will be shared pursuant to valid HIPAA 
Authorization, Informed Consent, and an appropriate written agreement 
limiting use of the data to the conditions described in the authorization 
and consent. 
   A Limited Dataset (LDS) will be created and shared pursuant to a 
Data Use Agreement (DUA) that indicates adherence to any applicable 
Informed Consent provisions, appropriately limits use of the dataset 
and prohibits the recipient from identifying or re-identifying (or taking 
steps to identify or re-identify) any individual whose data are included in 
the dataset. NOTE: An LDS does not necessarily imply de-identified 
data per HIPAA. 
   A De-identified, Anonymized Dataset will be created and shared.  
NOTE: ORO recommends that such sharing take place under a written 
agreement that adheres to any applicable Informed Consent provisions 
and prohibits the recipient from identifying or re-identifying (or taking 
steps to identify or re-identify) any individual whose data are included in 
the dataset. However, it is permissible for final datasets in machine-
readable format to be submitted to and accessed from PubMed Central 
(and similar sites) provided that care is taken to ensure that the 
individuals cannot be re-identified using other publicly available 
information. 
It is likely that requests for 
data from outside 
researchers (or other 
entities) may correspond 
to one or both  of the 
following special 
conditions: 
 
   Individually Identifiable Data, excluding Veterans’ names and 
38 USC §7332-protected information, will be shared, pursuant to a 
written request and IRB approved waiver of HIPAA authorization, with 
the approval of the Under Secretary for Health, in accordance with VHA 
Handbook 1605.1 §13.b(1)(b) or §13.b(1)(c) or superseding versions of 
that Handbook. Note: Subject to all other listed requirements, Veterans’ 
names may be shared with other Federal agencies (38 USC §5701), 
and with non-Federal investigators who provide the names and 
addresses of the individual subjects. 
   Individually Identifiable Data, including 38 USC 7332-protected 
information, will be shared, pursuant to the above requirements and a 
written assurance from the recipient that the information will be 
maintained in accordance with the security requirements of 38 CFR 
Part 1.466, or more stringent requirements, the information will not be 
re-disclosed except back to VA, and the information will not identify any 
individual patient in any report of the research or otherwise disclose 
patient identities. 

CMCVAMC IRB Form 101 
 
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HRPP Accepted: 08/21/2019 
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Additional details on mechanisms for sharing final data sets as indicated in Section 4 above. 
 
Section 5 - Briefly summarize how, where, when, to whom, and the extent to which data resulting 
from the research will be made available outside VA. 
Section 5 answer:   A limited de-identified dataset will be made available on our CMCVAMC research 
website that is publicly available. 
 
Section 6 - Describe how and where data resulting from the research will be stored and maintained 
(e.g., data will be stored and maintained in a secure ORD data repository or resource;  data will be 
stored on VA servers behind the VA firewall and backed up to a hard drive maintained and secured in 
the investigator’s lab; etc.). 
Section 6 answer:  The dataset will be housed on a server, administered by CHERP behind the VA 
firewall, access being granted only to those who apply directly to you, provide the necessary assurances 
that they will not re-identify the data, and submit to a clearance by the CMCVAMC Privacy Officer. The 
VA will not permit data to be stashed with NIH, not without a lot of data transfer approvals. 
 
Section 7 - Describe the mechanisms for ensuring the protection of personal privacy, the 
confidentiality of individually identifiable information, and the security of proprietary data and 
information. 
Section 7 answer:  All data will be de-identified prior to being made available. 
 
Section 8 - Describe the scientific and/or public purposes for making the data available (i.e., how will 
scientists and/or the public benefit from making the data available) and explain how the data available 
for sharing will permit validation of results by the recipients (e.g., sufficient data and descriptors will be 
made available to confirm conclusions in the publication, duplicate statistical analysis, perform additional 
analyses, etc.). 
Section 8 answer:  The scientific purpose of making this data available is to allow independent analysis 
of the data and to allow investigators to consider new analyses of the data that might further the study of 
opioid tapering among Veterans. 
 
Section 9 - Describe the mechanisms for ensuring the protection of personal privacy, the 
confidentiality of individually identifiable information, and the security of proprietary data and 
information. 
 
Section 9 answer:  See above - All data will be de-identified prior to being made available. 
 
Section 10 - Describe the scientific and/or public purposes for making the data available (i.e., how 
will scientists and/or the public benefit from making the data available) and explain how the data 
available for sharing will permit validation of results by the recipients (e.g., sufficient data and 
descriptors will be made available to confirm conclusions in the publication, duplicate statistical analysis, 
perform additional analyses, etc.). 
Section 10 answer:  See above - The scientific purpose of making this data available is to allow 
independent analysis of the data and to allow investigators to consider new analyses of the data that 
might further the study of opioid tapering among Veterans. 
 
Section 11 - As Principal Investigator for the proposed research, I attest to the accuracy of the 
information provided above, and I understand that – 
• Final data sets must be maintained locally in accordance with VA Records Control Schedule 10-1 
or until enterprise-level resources become available for long-term storage and access (unless 
otherwise required or permitted by the relevant VHA Program Office) 
• Failure to implement this DMAP may result in restrictions to subsequent research activities 

CMCVAMC IRB Form 101 
 
      Page 39 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
 
SECTION 21: ATTESTATION TO FOLLOW FEDERAL REGULATIONS  
 
As the Principal Investigator for this project, I certify that I have read, understand, and accept 
the investigator responsibilities as outlined in VHA Handbook 1200.05, paragraph 5g and that 
these include but are not limited to the following: 
 
• 
Giving first priority to the protection of human subjects; upholding professional and ethical 
standards and practices; and adhering to all applicable VA and other Federal requirements, 
include  IRB and the local VA Facility’s policies and procedures regarding the conduct of 
research and the protection of human subjects. 
 
• 
Ensuring all investigators and other staffs participating in this human subjects research are 
qualified; have the appropriate training, education, and experience to perform procedures 
assigned to them; and that they have been appropriately credentialed and privileged as 
applicable per current local facility and VA requirements. 
 
 
• 
Submitting all amendments to the project or changes in the informed consent to the  IRB for 
review and approval prior to initiation, except when necessary to eliminate immediate hazard to 
the participants.  Any changes implemented as a result of an immediate hazard will be promptly 
reported to the  IRB as a project deviation and an amendment submitted if determined 
necessary. 
 
• 
Obtaining and documenting legally effective informed consent of the subject or the subject’s 
legally authorized representative (LAR), as well as a HIPAA authorization, unless the IRB 
approves an applicable waiver. 
 
• 
Reporting problems, adverse events, and apparent serious or continuing noncompliance, 
including local research deaths, in accordance with VHA Handbook 1058.01, local VA Facility 
requirements, and  IRB SOPs (to include the  IRB Table of Reporting Requirements.) 
 
• 
Ensuring appropriate research records are maintained that includes all information made or 
received by a VA Investigator over the entire lifecycle of the research activity and that these 
records are maintained in accordance with the VA Records Control Schedule and local policies 
and procedures. 
 
• 
Providing continuing review and/or requested updates for the study as applicable in a timely 
manner and in accordance with the VA and  IRB policies and procedures. This includes 
submission of a closure reports for both local sites and the overall study upon completion. 
noncompliance. 
 
• 
Ensuring research does not start until final approval has been received from the  IRB, and writte 
notification from the local Facility ACOS/R&D in accordance with local R&D Committee approval 
policies and procedures. 
Signature or E-Signature of Principal Investigator, ONLY 
Date Signed 
 
Signature on hard copy in IRB 1 Office/emd 
 
 
 
 
SECTION 22: INSTITUTIONAL APPROVALS 
 

CMCVAMC IRB Form 101 
 
      Page 40 of 40 
Philadelphia (642)  
HRPP Accepted: 08/21/2019 
APPROVED BY CMCVAMC IRB ON 04/12/2022 
(I have read this proposal and find it in compliance with federal, state and local policies and 
regulations.  I have read and deemed the scientific quality of this proposal to be adequate and the 
proposal has scientific relevance to both the VA’s mission and the facility’s research program.  
Resources necessary for the performance of this proposed study are available and adequate.) 
 
Signature or E-Signature of Section Chief: 
 
 
 
Date: 
Signature or E-Signature of Service Chief: 
 
Signature on hard copy in IRB 1 Office/emd 
 
 
Date: 
Signature or E-Signature of Chief of Staff: 
 
 
 
(Chief of Staff’s signature needed for ACOS investigators only.) 
Date: