Clinical trial NCT06940986: The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System
Official title: The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Musculoskeletal Pain Disorder
Keywords: Empowered Relief
Move to Health
Holistic Pain Care
stepped care
chronic musculoskeletal pain
self-management
pain management
military
holistic health
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: 59th Medical Wing
name: Desmond Doss Health Clinic, Schofield Barracks
name: University of Utah
name: Madigan Army Medical Center
name: Bassett Army Community Hospital
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-04-23
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to improve pain care in the MHS by identifying effective, whole-person, non-pharmacologic interventions for persons with chronic musculoskeletal pain. The investigators will evaluate two promising, evidence-based holistic health interventions and compare them to usual care.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* TRICARE Beneficiary
* Meets the case definition of chronic MSK pain requiring 2 or more medical encounters within the past year and at least 90 days apart for the same MSK condition indicated by medical encounter data or MSK pain ICD-10 codes in the electronic medical record

Exclusion Criteria:

* Actively receiving cancer treatment
* Currently known to be pregnant
* Receiving advanced chronic pain management, including multi-disciplinary or behavioral pain management or mental health or substance use programs (beyond the initial step of the VA/DoD stepped care model for pain management)
* Suicidal Ideation determined by a higher than lower risk score on the P4 Screener
* Currently undergoing post-surgical rehabilitation

Primary outcomes:
measure: 3-PEG Scale
timeFrame: From enrollment to the end of treatment at 14 weeks
Secondary outcomes:
measure: PROMIS Physical Function
timeFrame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
measure: PROMIS Sleep Disturbance
timeFrame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
measure: 3-PEG Scale
timeFrame: From enrollment to the end of the surveillance period (26 and 52 weeks)
measure: PROMIS Depression
timeFrame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
measure: PROMIS Fatigue
timeFrame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
measure: PROMIS Prescription Medication Misuse
timeFrame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
measure: Sleep Duration
timeFrame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
measure: Pain Self-Efficacy Scale (PSEQ)
timeFrame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
Other outcomes:
Locations:
city: Fairbanks
country: United States
facility: Bassett Army Community Hospital
state: Alaska
city: Schofield Barracks
country: United States
facility: Desmond Doss Health Clinic
state: Hawaii
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: University of Utah
name: Julie M Fritz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brooke Army Medical Center
name: Daniel I Rhon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abiero B, Gliner M, Beamer S, Sackett A, Marshall-Aiyelawo K, Ellison J, McDavid T, de Geus J. Military Medical Readiness and Patient Experience with Access to Care. Med J (Ft Sam Houst Tex). 2022 Jan-Mar;(Per 22-01/02/03):3-10.
citation: Adams RS, Thomas CP, Ritter GA, Lee S, Saadoun M, Williams TV, Larson MJ. Predictors of Postdeployment Prescription Opioid Receipt and Long-term Prescription Opioid Utilization Among Army Active Duty Soldiers. Mil Med. 2019 Jan 1;184(1-2):e101-e109. doi: 10.1093/milmed/usy162.
citation: Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/
citation: Department of Veterans Affairs. Veterans' Health Administration. Pain Management, VHA Directive 2009-053. October 28, 2009. Published 2009. Accessed August 25, 2023.
citation: Toblin RL, Quartana PJ, Riviere LA, Walper KC, Hoge CW. Chronic pain and opioid use in US soldiers after combat deployment. JAMA Intern Med. 2014 Aug;174(8):1400-1. doi: 10.1001/jamainternmed.2014.2726. No abstract available.