The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 608
- 试验地点
- 10
- 主要终点
- 3-PEG Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Empowered Relief
Empowered Relief uses a single, 2-hour session to accomplish several key tasks including; pain education; experiential exercises; didactic content on pain responses, stress, and tension; techniques to affect the relaxation response; basic unhelpful thought restructuring; self-soothing actions; and completion of a per-sonalized self-management plan for empowered relief. Similar to CBT relaxation, ER participants receive a calming tool in the form of a binaural app. Unlike CBT, ER is mainly didactic, omits content such as activity planning and pacing, and is provided in a single session, eliminating ongoing therapeutic alliance and peer support.
干预措施: Empowered Relief (Behavioral)
Move to Health
Move to Health (M2H) is part of an initiative in the Military Health System to transform healthcare delivery with emphasis on the power of holistic care and self-management. M2H is operationalized using a health coaching model based on collaborative part-nership between patient and a trained coach to facilitate healthy behavior change. Health coaching is an evidence-based intervention for persons with chronic pain with improvements in physical activity, pain intensity and interference.
干预措施: Move to Health (Behavioral)
Usual Care
Usual care (UC) pain management will be provided at the discretion of the participant's primary care provider, consistent with a pragmatic clinical trial.
Persons assigned to UC will be advised to follow the recommendations from their primary care provider and will be provided information about local resources at their respective Military Treatment Facility. The study team will not take additional steps to standardize or compel adherence to practice guidelines and will collect health care utilization outcomes through the the Millitary Health System Data Repository at the conclusion of the trial.
干预措施: Usual Care as determined by primary care provider (Other)
结局指标
主要结局
3-PEG Scale
时间窗: From enrollment to the end of treatment at 14 weeks
The three items include 1 pain intensity item (Pain intensity during the past week) and 2 pain interference items (Pain interference with Enjoyment of life, and pain interference with General activity). The total score is the average of the three items (range, 0-10; higher scores indicate worse pain impact)
次要结局
- PROMIS Physical Function(From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments))
- PROMIS Sleep Disturbance(From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments))
- 3-PEG Scale(From enrollment to the end of the surveillance period (26 and 52 weeks))
- PROMIS Depression(From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments))
- PROMIS Fatigue(From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments))
- PROMIS Prescription Medication Misuse(From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments))
- Sleep Duration(From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments))
- Pain Catastrophizing Scale (PCS)(From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments))
- Pain Self-Efficacy Scale (PSEQ)(From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments))
研究者
Dan Rhon
Primary Investigator
Brooke Army Medical Center