M2VA Pain Care Pathway

NCT06526143 | Recruiting DMC

• 2 other identifiers: 2000035529UG3AT012262
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Pain; Substance Use; Opioid Misuse; Quality of Life

Keywords

case management; SBIRT

Outcome Measures

Primary Outcomes (2)

• Reach

  Proportion of participants who receive any M2VAPCP

  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.

  36 weeks

Secondary Outcomes (4)

• Adoption

  21 months

• Implementation

  21 months

• ASSIST-3

  36 weeks

• Pain Treatments Used

  36 weeks

Study Arms (2)

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

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.

Behavioral: M2VA Pain Care Pathway (M2VAPCP); Behavioral: Implementation Facilitation

Interventions

M2VA Pain Care Pathway (M2VAPCP) BEHAVIORAL

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 Facilitation + Training-As-Usual; Training-As-Usual

Implementation Facilitation BEHAVIORAL

Implementation 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.

Implementation Facilitation + Training-As-Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• VA Connecticut Healthcare System: collaborator

Study Sites (1)

VA Connecticut Healthcare System (VACHS)

West Haven, Connecticut, 06516, United States

RECRUITING

MeSH Terms

Conditions

Pain; Substance-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• Marc Rosen, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Lazar, MPH

CONTACT

203-932-5711; christina.lazar@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants collecting follow-up data will be blind to site's randomization group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sites will be assigned to receive (1) training-as-usual or (2) training plus implementation facilitation.

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)