Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1800 participants
INTERVENTIONAL
2024-09-18
2028-07-31
Brief Summary
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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?
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Training-As-Usual
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
M2VA Pain Care Pathway (M2VAPCP)
M2VAPCP 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 + Training-As-Usual
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.
M2VA Pain Care Pathway (M2VAPCP)
M2VAPCP 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
Implementation 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.
Interventions
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M2VA Pain Care Pathway (M2VAPCP)
M2VAPCP 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
Implementation 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Does not have a landline or cell phone to complete study assessments
* Is unable to provide informed consent
* Still on active duty
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
VA Connecticut Healthcare System
FED
Yale University
OTHER
Responsible Party
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Principal Investigators
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Marc Rosen, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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VA Connecticut Healthcare System (VACHS)
West Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2000035529
Identifier Type: -
Identifier Source: org_study_id
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