Clinical trial NCT06526143: M2VA Pain Care Pathway
Official title: Implementation Facilitation of Screening, Brief Intervention, and Referral to Treatment for Pain Management for Veterans Separating From Military Service
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Substance Use
Opioid Misuse
Quality of Life
Keywords: case management
SBIRT
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: VA Connecticut Healthcare System
First posted: 2024-07-29
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sites will be assigned to receive (1) training-as-usual or (2) training plus implementation facilitation.
Primary purpose: PREVENTION

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?

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reach
timeFrame: 21 months
measure: Pain, Enjoyment of Life and General Activity scale
timeFrame: 36 weeks
Secondary outcomes:
measure: Adoption
timeFrame: 21 months
measure: Implementation
timeFrame: 21 months
measure: ASSIST-3
timeFrame: 36 weeks
measure: Pain Treatments Used
timeFrame: 36 weeks
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System (VACHS)
state: Connecticut
Study officials:
affiliation: Yale University
name: Marc Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References: