The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System

Chronic pain is a ubiquitous problem and growing concern for the Military Health System (MHS). Chronic musculoskeletal (MSK) pain conditions are the most common chronic pain conditions in the MHS. Numerous recommendations have been made to improve care for chronic MSK pain in the MHS. First, the Office of the Army Surgeon General is promoting the transition of the MHS to a holistic health system that seeks to maintain, restore, and improve health through team-based care supporting self-management and recognizing the complex, biopsychosocial nature of chronic pain. Second, a stepped care approach to pain management is advocated to make less intense but effective, first-line care broadly available and to base subsequent care on response to first-line options. While the MHS has articulated its vision for holistic pain care delivered within a stepped care framework, there is a need for research addressing key questions of which interventions are most effective and how to operationalize the stepped care model. In addition, pragmatic, sustainable strategies to implement holistic pain care in the MHS are needed. Electronic health records (EHR) are increasingly used to implement evidence-based interventions, but have not been widely tested in the MHS. The MHS has deployed a new system-wide EHR with standards-based capabilities for decision-support, making EHR-based implementation a timely option with high potential for future scalability.

Design: Pragmatic, individually-randomized, type I hybrid effectiveness-implementation trial Methods: The investigators will use the EMR to help facilitate recruitment. The investigators plan to recruit a total of 608 persons with chronic MSK pain receiving care in the MHS. Participants providing consent will be randomized in 1 : 2.3 : 2.3 ratio to Usual Care (UC), Empowered Relief (ER), or Move to Health (M2H) for phase I treatment. All participants will be re-evaluated after 14 weeks. Participants initially assigned to the ER, determined to be non-responders to treatment, will receive M2H as a Phase II intervention to evaluate a stepped care process. All participants will also complete assessments at 26 and 52 weeks after randomization. The primary outcome will be a self-reported measure of pain impact. Secondary outcomes will include additional effectiveness measures. The research team will also evaluate implementation outcomes grounded in a Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Summary: The goal of the promoting pain self-management (PROs) study is to improve pain care in the MHS by identifying effective, whole-person, non-pharmacologic interventions for persons with chronic MSK pain. The investigators plan to evaluate two promising, evidence-based interventions, ER and M2H, and also compare these to UC.

• PROMIS Physical Function [Срок оценки: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)]
• PROMIS Sleep Disturbance [Срок оценки: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)]
• 3-PEG Scale [Срок оценки: From enrollment to the end of the surveillance period (26 and 52 weeks)]
• PROMIS Depression [Срок оценки: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)]
• PROMIS Fatigue [Срок оценки: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)]
• PROMIS Prescription Medication Misuse [Срок оценки: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)]
• Sleep Duration [Срок оценки: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)]
• Pain Catastrophizing Scale (PCS) [Срок оценки: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)]
• Pain Self-Efficacy Scale (PSEQ) [Срок оценки: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)]