M2VA Pain Care Pathway
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
M2VA Pain Care Pathway (M2VAPCP)
BehavioralM2VAPCP is a manualized Motivational Interviewing-based intervention, designed to motivate Veterans to engage in multimodal nonpharmacological pain care and reduce substance misuse when present. The first session includes empathic exploration of the Veteran's MSD, pain experiences, and motivations for pain care; psychoeducation about the benefits of multimodal pain care and judicious use of non-opioid medications; information about available pain management services and treatments for conditions that might exacerbate chronic pain; screening for substance misuse, including prescription medications, and motivational enhancement to change behaviors related to positive screens; and for those interested, making plans to achieve these goals. Over 12 weeks, case managers will hold up to two additional sessions with participants to check on their goal achievement and continue motivational enhancement for multimodal pain treatment and reduced substance misuse.
Implementation Facilitation
BehavioralImplementation facilitation teams consisting of internal and external facilitators will conduct activities for two purposes: 1. to build working relationships within the pain and addiction care pathways to achieve the shared goal of implementing high-quality M2VAPCP; and 2. to promote constructive, problem-solving oriented communication based on indicators of M2VAPCP implementation progress. Activities will include Virtual Site Visits, all-side facilitation team meetings, local facilitation team meetings, M2VAPCP consultation groups, learning collaboratives, case identification reports and audit and feedback.
Treatment groups
1,800 Participants
are divided into 2 treatment groupsGroup A: Training-As-UsualActive comparator 1 intervention
Group B: Implementation Facilitation + Training-As-UsualExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Reach
Proportion of participants who receive any M2VAPCP
Time frame
21 months2
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.
Time frame
36 weeksSecondary outcomes
1
Adoption
Proportion of case managers who receive training in M2VAPCP and proportion of those trained who used M2VAPCP with at least three participants
Time frame
21 months2
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.
Time frame
21 months3
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).
Time frame
36 weeks4
Pain Treatments Used
The number of nonpharmacological pain treatment services used, derived from the VA electronic health system records.
Time frame
36 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
VA Connecticut Healthcare System
Collaborator
Source ClinicalTrials.gov