M2VA Pain Care Pathway

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• VA Connecticut Healthcare System

  collaborator FED

• Yale University

  lead OTHER

Principal Investigators

• Marc Rosen, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-18

Primary Completion

2028-07-31

Completion

2028-07-31

Countries

• United States

Study Locations