M2VA Pain Care Pathway

Phase

N/A

Condition

Pain

Stimulant Use Disorder

Opioid Use Disorder

Treatment

Implementation Facilitation

M2VA Pain Care Pathway (M2VAPCP)

Clinical Study ID

NCT06526143

2000035529

UG3AT012262

Ages > 18
All Genders

Study 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?

Eligibility Criteria

Inclusion

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 shouldercondition)
Lives within the catchment area of a participating site

Exclusion

Exclusion Criteria:

Reports being unable to complete planned study assessments because of anticipatedincapacity, 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

Implementation Facilitation

September 18, 2024

July 31, 2028

Study 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.

Connect with a study center

VA Connecticut Healthcare System (VACHS)
West Haven, Connecticut 06516
United States
Site Not Available
VA Connecticut Healthcare System (VACHS)
West Haven 4845419, Connecticut 4831725 06516
United States
Active - Recruiting

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