Recruiting

Pain Care Pathway

Sponsor:

Yale University

Code:

NCT06526143

Conditions

Pain

Substance Use

Opioid Misuse

Quality of Life

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

M2VA Pain Care Pathway (M2VAPCP)

Implementation Facilitation

Study Details

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

Study ID

NCT06526143

Start date

Sep 18, 2024

Status verified date

Nov, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

1800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Training-As-Usual

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

experimental: Implementation Facilitation + Training-As-Usual

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.

Interventions

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.

Implementation Facilitation

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.

Primary outcome measure

  • Reach [ Time Frame: 21 months ]
  • Pain, Enjoyment of Life and General Activity scale [ Time Frame: 36 weeks ]

Central Contacts and Locations

Central contacts

Locations

VA Connecticut Healthcare System (VACHS)

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Principal Investigator:

Marc I Rosen, MD

More Information

Sponsor

Yale University

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Keywords

  • case management
  • SBIRT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-11-05.