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Behavioral Intervention

M2VA Pain Care Pathway for Pain (M2VAPCP Trial)

N/A

Recruiting

Led By Marc Rosen, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has filed a service-connection claim for an MSD (back, neck, knee, or shoulder condition)

Be older than 18 years old

Must not have

Is unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if providing additional support to M2VA case managers will help them better implement the Military2VA Pain Care Pathway intervention. They want to know if this extra support will lead

Who is the study for?

This trial is for veterans dealing with pain and at risk of or currently facing substance use issues, specifically opioid abuse. It's designed to help case managers better adopt a special care pathway to improve these veterans' quality of life.

What is being tested?

The study tests if adding extra support (implementation facilitation) helps case managers more effectively use the M2VA Pain Care Pathway compared to just standard training. The goal is to see if this leads to better care and outcomes for veterans.

What are the potential side effects?

Since this trial focuses on implementing a care pathway rather than testing a drug, it doesn't have typical medication side effects. However, there may be indirect effects on patients' experiences based on how well the intervention works.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have filed a claim for a service-connected musculoskeletal disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain, Enjoyment of Life and General Activity scale

Reach

Secondary study objectives

ASSIST-3

Adoption

Implementation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Implementation Facilitation + Training-As-UsualExperimental Treatment2 Interventions

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.

Group II: Training-As-UsualActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Implementation Facilitation

2019

N/A

~8690

0 / 2Eligibility criteria met