M2VA Pain Care Pathway

Официальное название

Implementation Facilitation of Screening, Brief Intervention, and Referral to Treatment for Pain Management for Veterans Separating From Military Service

Обзор

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?

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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 te

Первичные конечные точки

• Reach [Срок оценки: 21 months]
• Pain, Enjoyment of Life and General Activity scale [Срок оценки: 36 weeks]

Вторичные конечные точки (4)

• Adoption [Срок оценки: 21 months]
• Implementation [Срок оценки: 21 months]
• ASSIST-3 [Срок оценки: 36 weeks]
• Pain Treatments Used [Срок оценки: 36 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• VA Connecticut Healthcare System (VACHS) — West Haven

Идентификаторы

NCT: NCT06526143 · 2000035529 · UG3AT012262

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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