PainM2VAPCPNCT06526143
M2VA Pain Care Pathway
A study testing M2VA Pain Care Pathway (M2VAPCP) and Implementation Facilitation in people with Pain and Substance Use, run by Yale University at 1 site in United States.
Trial summary
The goal of this 2-cohort, cluster randomized, type 2 hybrid trial is to test the effectiveness, cost-effectiveness and patient-level effects of an implementation facilitation strategy in helping M2VA case managers adopt a Military2VA Pain Care Pathway (M2VAPCP) intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Substance Use, Opioid Misuse
- What is being tested?
- M2VA Pain Care Pathway (M2VAPCP) and Implementation Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study enrollment is within one year of ending military service
- Has filed a service-connection claim for an MSD (back, neck, knee, or shoulder condition)
- Lives within the catchment area of a participating site
Who cannot join
- Reports being unable to complete planned study assessments because of anticipated incapacity, incarceration, or other reason
- Does not have a landline or cell phone to complete study assessments
- Is unable to provide informed consent
- Still on active duty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Connecticut Healthcare System (VACHS)
West Haven, Connecticut, 06516
Christina M Lazar, MPH, 203-932-5711 ext. 4833, christina.lazar@yale.edu
Marc I Rosen, MD
About this study
Official title: Implementation Facilitation of Screening, Brief Intervention, and Referral to Treatment for Pain Management for Veterans Separating From Military Service
The goal of this 2-cohort, cluster randomized, type 2 hybrid trial is to test the effectiveness, cost-effectiveness and patient-level effects of an implementation facilitation strategy in helping M2VA case managers adopt a Military2VA Pain Care Pathway (M2VAPCP) intervention.
The main questions it aims to answer are:
Will adding implementation facilitation to training-as-usual for M2VAPCP result in a higher proportion of Veterans who receive M2VAPCP compared to training-as-usual alone? Will adding implementation facilitation to training-as-usual for M2VAPCP result in better adherence to the M2VAPCP protocol compared to training-as-usual alone? Will implementation facilitation improve Veterans' clinical outcomes (pain, risky substance use) and increase the number of non-pharmacological pain treatments used compared to training-as-usual alone?
Read the detailed description
Investigators will conduct a type 2 hybrid cluster randomized trial to test the effectiveness, cost-effectiveness, and patient-level effects of an implementation facilitation strategy to train case managers in the Post-9/11 Military2VA (M2VA) program in a pain and substance use-focused Military2VA Pain Care Pathway (M2VAPCP) intervention.
Aim 1: Determine if implementation facilitation (IF) of training case managers in M2VAPCP more effectively fosters M2VAPCP's use than training-as-usual. The primary implementation outcome will be the proportion of participants who receive any M2VAPCP (Reach). Other implementation outcomes will be the proportion of case managers who receive training in M2VAPCP and proportion of those trained who used M2VAPCP with at least three participants (Adoption), and the integrity of case managers' use of Motivational Interviewing in M2VAPCP sessions (Implementation). Factors affecting case managers' ongoing use of M2VAPCP as part of their practice (Maintenance) and experience with implementation facilitation, M2VAPCP and navigating VA pain care services will be explored qualitatively for each cohort in a formative evaluation.
Aim 2: Determine if implementation facilitation of M2VAPCP improves participants' clinical outcomes. The primary clinical outcome is the PEG measure of pain. Secondary outcomes will be the ASSIST-3 measure of substance use (with biochemical verification of alcohol report using fingernails), and EHR-derived number of nonpharmacologic pain management services used.
Aim 3: Determine the cost-effectiveness and budget impact of implementation facilitation relative to training-as-usual to reach Veterans with M2VAPCP and improve their clinical outcomes.
- Conditions
- Pain, Substance Use, Opioid Misuse, Quality of Life
- Being tested
- M2VA Pain Care Pathway (M2VAPCP), Implementation Facilitation
- Keywords
- case management, SBIRT
- Medical subject headings
- Pain, Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M2VA Pain Care Pathway (M2VAPCP)Behavioural
M2VAPCP is a manualized Motivational Interviewing-based intervention, designed to motivate Veterans to engage in multimodal nonpharmacological pain care and reduce substance misuse when present. The first session includes empathic exploration of the Veteran's MSD, pain experiences, and motivations for pain care; psychoeducation about the benefits of multimodal pain care and judicious use of non-opioid medications; information about available pain management services and treatments for conditions that might exacerbate chronic pain; screening for substance misuse, including prescription medications, and motivational enhancement to change behaviors related to positive screens; and for those interested, making plans to achieve these goals. Over 12 weeks, case managers will hold up to two additional sessions with participants to check on their goal achievement and continue motivational enhancement for multimodal pain treatment and reduced substance misuse.
Implementation FacilitationBehavioural
Implementation facilitation teams consisting of internal and external facilitators will conduct activities for two purposes:
- to build working relationships within the pain and addiction care pathways to achieve the shared goal of implementing high-quality M2VAPCP; and
- to promote constructive, problem-solving oriented communication based on indicators of M2VAPCP implementation progress.
Activities will include Virtual Site Visits, all-side facilitation team meetings, local facilitation team meetings, M2VAPCP consultation groups, learning collaboratives, case identification reports and audit and feedback.
| Study group | Role | What they receive |
|---|---|---|
| Training-As-Usual | Active comparator | M2VA case managers at sites randomized to TAU will receive an initial 8-hour virtual didactic and experiential workshop conducted by an experienced Motivational Interviewing and M2VAPCP trainer, Dr. Martino, who is a longstanding member of the Motivational Interviewing Network of Trainers. The first four hours of the workshop will focus on principles and practices of Motivational Interviewing. The last four hours will be a review the M2VAPCP protocol, with demonstration and practice of its elements. Following the workshop, case managers will have up to seven opportunities to practice M2VAPCP with simulated patients over a 21-month period Receives: Behavioral: M2VA Pain Care Pathway (M2VAPCP) |
| Implementation Facilitation + Training-As-Usual | Experimental | M2VA case managers at sites randomized to IF+TAU will receive the M2VAPCP training workshop described above and IF delivered virtually for 21 months after receiving the M2VAPCP training workshop. IF for this trial will be organized around three major components: 1) an external facilitation team consisting of clinical and implementation experts who will work with internal facilitators at each site; 2) multifaceted activities to support the use of M2VAPCP; and 3) ongoing formative evaluation. Receives: Behavioral: M2VA Pain Care Pathway (M2VAPCP); Behavioral: Implementation Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
Proportion of participants who receive any M2VAPCP
Measured: 21 months
Pain, Enjoyment of Life and General Activity scale
Three questions about the past week's pain. One question asks about pain severity and two questions ask about pain interference. Each item is rated on a 0-10 Likert scale. Responses are added together and divided by three to get a final score out of 10. A higher score indicates more severe pain and pain-related interference with life and activities.
Measured: 36 weeks
Secondary outcomes (4)
Adoption
Proportion of case managers who receive training in M2VAPCP and proportion of those trained who used M2VAPCP with at least three participants
Measured: 21 months
Implementation
Integrity of case managers' use of Motivational Interviewing (MI) in M2VAPCP sessions. Measured with LYSSN-generated overall quality score. The score ranges from 0-12 and summarizes MI proficiency across 6 MI fidelity metrics: empathy, collaboration, % reflections, % questions, % MI adherence, and ratio of reflections to questions. Each of the 6 metrics is scored 0,1, or 2 on whether the score met criteria for basic or advanced competency, using cutoffs from the MITI v3.1.1 manual. This score summarizes the quality of MI delivered, with higher scores indicating better MI performance.
Measured: 21 months
ASSIST-3
Substance use will be measured over the last 3 months using Version 3.1 of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). After a screening question focusing on substances ever used, the ASSIST consists of seven questions about use of and consequences of use of each of ten classes of substances over the preceding three months (including nicotine). For each substance category, the score of seven questions are summed to produce a risk score, and risk scores are grouped into 'low risk', 'moderate risk' or 'high risk' which determines the level of intervention recommendation (no intervention, brief intervention or brief intervention plus referral to specialist treatment).
Measured: 36 weeks
Pain Treatments Used
The number of nonpharmacological pain treatment services used, derived from the VA electronic health system records.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start18 Sep 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sites will be assigned to receive (1) training-as-usual or (2) training plus implementation facilitation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), VA Connecticut Healthcare System
- Responsible party
- Sponsor
- Investigators
- Marc Rosen, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526143
- Sponsor's protocol ID
- 2000035529
- Other IDs
- UG3AT012262
- Acronym
- M2VAPCP
- Status last verified
- Nov 2025
- First submitted
- 23 Jul 2024
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Facilitation of Screening, Brief Intervention, and Referral to Treatment for Pain Management for Veterans Separating From Military Service
- ClinicalTrials.gov ID
- NCT06526143
- Acronym / sponsor ID
- M2VAPCP / 2000035529
- Conditions
- Pain, Substance Use, Opioid Misuse, Quality of Life
- Keywords
- case management, SBIRT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), VA Connecticut Healthcare System
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this 2-cohort, cluster randomized, type 2 hybrid trial is to test the effectiveness, cost-effectiveness and patient-level effects of an implementation facilitation strategy in helping M2VA case managers adopt a Military2VA Pain Care Pathway (M2VAPCP) intervention.
The main questions it aims to answer are:
Will adding implementation facilitation to training-as-usual for M2VAPCP result in a higher proportion of Veterans who receive M2VAPCP compared to training-as-usual alone? Will adding implementation facilitation to training-as-usual for M2VAPCP result in better adherence to the M2VAPCP protocol compared to training-as-usual alone? Will implementation facilitation improve Veterans' clinical outcomes (pain, risky substance use) and increase the number of non-pharmacological pain treatments used compared to training-as-usual alone?
Detailed description
Investigators will conduct a type 2 hybrid cluster randomized trial to test the effectiveness, cost-effectiveness, and patient-level effects of an implementation facilitation strategy to train case managers in the Post-9/11 Military2VA (M2VA) program in a pain and substance use-focused Military2VA Pain Care Pathway (M2VAPCP) intervention.
Aim 1: Determine if implementation facilitation (IF) of training case managers in M2VAPCP more effectively fosters M2VAPCP's use than training-as-usual. The primary implementation outcome will be the proportion of participants who receive any M2VAPCP (Reach). Other implementation outcomes will be the proportion of case managers who receive training in M2VAPCP and proportion of those trained who used M2VAPCP with at least three participants (Adoption), and the integrity of case managers' use of Motivational Interviewing in M2VAPCP sessions (Implementation). Factors affecting case managers' ongoing use of M2VAPCP as part of their practice (Maintenance) and experience with implementation facilitation, M2VAPCP and navigating VA pain care services will be explored qualitatively for each cohort in a formative evaluation.
Aim 2: Determine if implementation facilitation of M2VAPCP improves participants' clinical outcomes. The primary clinical outcome is the PEG measure of pain. Secondary outcomes will be the ASSIST-3 measure of substance use (with biochemical verification of alcohol report using fingernails), and EHR-derived number of nonpharmacologic pain management services used.
Aim 3: Determine the cost-effectiveness and budget impact of implementation facilitation relative to training-as-usual to reach Veterans with M2VAPCP and improve their clinical outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Sites will be assigned to receive (1) training-as-usual or (2) training plus implementation facilitation.
| Arm | Type | Receives |
|---|---|---|
| Training-As-Usual | Active comparator | Behavioral: M2VA Pain Care Pathway (M2VAPCP)M2VA case managers at sites randomized to TAU will receive an initial 8-hour virtual didactic and experiential workshop conducted by an experienced Motivational Interviewing and M2VAPCP trainer, Dr. Martino, who is a longstanding member of the Motivational Interviewing Network of Trainers. The first four hours of the workshop will focus on principles and practices of Motivational Interviewing. The last four hours will be a review the M2VAPCP protocol, with demonstration and practice of its elements. Following the workshop, case managers will have up to seven opportunities to practice M2VAPCP with simulated patients over a 21-month period |
| Implementation Facilitation + Training-As-Usual | Experimental | Behavioral: M2VA Pain Care Pathway (M2VAPCP), Behavioral: Implementation FacilitationM2VA case managers at sites randomized to IF+TAU will receive the M2VAPCP training workshop described above and IF delivered virtually for 21 months after receiving the M2VAPCP training workshop. IF for this trial will be organized around three major components: 1) an external facilitation team consisting of clinical and implementation experts who will work with internal facilitators at each site; 2) multifaceted activities to support the use of M2VAPCP; and 3) ongoing formative evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Study enrollment is within one year of ending military service
- Has filed a service-connection claim for an MSD (back, neck, knee, or shoulder condition)
- Lives within the catchment area of a participating site
Key exclusion criteria (4 listed)
- Reports being unable to complete planned study assessments because of anticipated incapacity, incarceration, or other reason
- Does not have a landline or cell phone to complete study assessments
- Is unable to provide informed consent
- Still on active duty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M2VA Pain Care Pathway (M2VAPCP)M2VAPCP is a manualized Motivational Interviewing-based intervention, designed to motivate Veterans to engage in multimodal nonpharmacological pain care and reduce substance misuse when present. The first session includes empathic exploration of the Veteran's MSD, pain experiences, and motivations for pain care; psychoeducation about the benefits of multimodal pain care and judicious use of non-opioid medications; information about available pain management services and treatments for conditions that might exacerbate chronic pain; screening for substance misuse, including prescription medications, and motivational enhancement to change behaviors related to positive screens; and for those interested, making plans to achieve these goals. Over 12 weeks, case managers will hold up to two additional sessions with participants to check on their goal achievement and continue motivational enhancement for multimodal pain treatment and reduced substance misuse. | Behavioural | Implementation Facilitation + Training-As-Usual, Training-As-Usual |
| Implementation FacilitationImplementation facilitation teams consisting of internal and external facilitators will conduct activities for two purposes: 1. to build working relationships within the pain and addiction care pathways to achieve the shared goal of implementing high-quality M2VAPCP; and 2. to promote constructive, problem-solving oriented communication based on indicators of M2VAPCP implementation progress. Activities will include Virtual Site Visits, all-side facilitation team meetings, local facilitation team meetings, M2VAPCP consultation groups, learning collaboratives, case identification reports and audit and feedback. | Behavioural | Implementation Facilitation + Training-As-Usual |
Primary outcome
Reach
Time frame: 21 months
Proportion of participants who receive any M2VAPCP
Pain, Enjoyment of Life and General Activity scale
Time frame: 36 weeks
Three questions about the past week's pain. One question asks about pain severity and two questions ask about pain interference. Each item is rated on a 0-10 Likert scale. Responses are added together and divided by three to get a final score out of 10. A higher score indicates more severe pain and pain-related interference with life and activities.
4 secondary outcomes
Adoption
Time frame: 21 months
Implementation
Time frame: 21 months
ASSIST-3
Time frame: 36 weeks
Pain Treatments Used
Time frame: 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Rosen, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M2VA Pain Care Pathway (M2VAPCP) and Implementation Facilitation in people with Pain and Substance Use, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Lazar, MPH (203-932-5711 ext. 4833, christina.lazar@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: 21 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.