M2VA Pain Care Pathway (M2VAPCP)

Yale University

Status: Enrolling

Conditions: Substance Use; Quality of Life; Pain; Opioid Misuse

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT06526143

2000035529

UG3AT012262 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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?

Full 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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,800 participants in 2 patient groups

Training-As-Usual

Active Comparator group

Description:

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

Treatment:

Behavioral: M2VA Pain Care Pathway (M2VAPCP)

Implementation Facilitation + Training-As-Usual

Experimental group

Description:

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.

Treatment:

Behavioral: M2VA Pain Care Pathway (M2VAPCP)

Behavioral: Implementation Facilitation