M2VA Pain Care Pathway
NCT Number: NCT06526143
Acronym: M2VAPCP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Substance Use|Opioid Misuse|Quality of Life
Interventions: BEHAVIORAL: M2VA Pain Care Pathway (M2VAPCP)|BEHAVIORAL: Implementation Facilitation
Sponsor: Yale University
Collaborators: National Center for Complementary and Integrative Health (NCCIH)|VA Connecticut Healthcare System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1800
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2028-07
Locations: VA Connecticut Healthcare System (VACHS), West Haven, Connecticut, 06516, United States

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?

Primary Outcome Measures: Reach, Proportion of participants who receive any M2VAPCP, 21 months|Pain, Enjoyment of Life and General Activity scale, Three questions about the past week's pain. One question asks about pain severity and two questions ask about pain interference. Each item is rated on a 0-10 Likert scale. Responses are added together and divided by three to get a final score out of 10. A higher score indicates more severe pain and pain-related interference with life and activities., 36 weeks
Secondary Outcome Measures: Adoption, Proportion of case managers who receive training in M2VAPCP and proportion of those trained who used M2VAPCP with at least three participants, 21 months|Implementation, Integrity of case managers' use of Motivational Interviewing (MI) in M2VAPCP sessions. Measured with LYSSN-generated overall quality score. The score ranges from 0-12 and summarizes MI proficiency across 6 MI fidelity metrics: empathy, collaboration, % reflections, % questions, % MI adherence, and ratio of reflections to questions. Each of the 6 metrics is scored 0,1, or 2 on whether the score met criteria for basic or advanced competency, using cutoffs from the MITI v3.1.1 manual. This score summarizes the quality of MI delivered, with higher scores indicating better MI performance., 21 months|ASSIST-3, Substance use will be measured over the last 3 months using Version 3.1 of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). After a screening question focusing on substances ever used, the ASSIST consists of seven questions about use of and consequences of use of each of ten classes of substances over the preceding three months (including nicotine). For each substance category, the score of seven questions are summed to produce a risk score, and risk scores are grouped into 'low risk', 'moderate risk' or 'high risk' which determines the level of intervention recommendation (no intervention, brief intervention or brief intervention plus referral to specialist treatment)., 36 weeks|Pain Treatments Used, The number of nonpharmacological pain treatment services used, derived from the VA electronic health system records., 36 weeks