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| Name | Class |
|---|---|
| 59th Medical Wing | FED |
| Desmond Doss Health Clinic, Schofield Barracks | UNKNOWN |
| University of Utah | OTHER |
| Madigan Army Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empowered Relief | Active Comparator | 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. |
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| Move to Health | Active Comparator | 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. |
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| Usual Care | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empowered Relief | Behavioral | ER is provided in a single, 2-hour session delivered remotely by trained instructors. ER has two main components: didactics and skills acquisition as outlined below. The ER class is administered virtually. The class includes the didactic and skill acquisition content. At the end of the class participants receive tangible items including the self-crafted, personalized catastrophizing cessation plan, a guided relaxation response audio file, and an electronic copy of the didactic class content. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-PEG Scale | 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) | From enrollment to the end of treatment at 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Physical Function | The PROMIS short form 6b for physical function uses fixed items from the PROMIS physical function item bank to provide a T-score with population mean = 50 (sd=10).96 | From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments) |
| PROMIS Sleep Disturbance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tina Greenlee, PhD | Contact | 210-808-2575 | tina.a.greenlee.ctr@health.mil | |
| Rachel Mayhew, DPT | Contact | rachel.J.mayhew.ctr@health.mil |
| Name | Affiliation | Role |
|---|---|---|
| Julie M Fritz, PhD | University of Utah | Principal Investigator |
| Daniel I Rhon, PhD | Brooke Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bassett Army Community Hospital | Not yet recruiting | Fairbanks | Alaska | 99703 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34940962 | Background | 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. | |
| 30007291 | Background | 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. |
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De-identified demographic data (e.g., sex, age), and participant-reported outcomes data.
Data will be stored in a repository as required by the sponsor/funder (NCCIH).
The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution. Access to data is sometimes restricted and users are expected to adhere to norms for responsible use. Restricted data files are not available for direct download from the website. Users interested in obtaining these data must complete a Restricted Data Use Agreement, specify the reason for the request, and obtain IRB approval or notice of exemption for their research.
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| FED |
| Bassett Army Community Hospital | UNKNOWN |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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| Move to Health | Behavioral | The M2H intervention is delivered virtually by trained health coaches using a 6-step process. The administration of M2H begins with an initial session with follow-up sessions scheduled every 1-2 weeks for up to 8 weeks or until the participant is ready to transition to self-management. |
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| Usual Care as determined by primary care provider | Other | Patients will receive care as determined by their primary care provider, with no input or control by the research team. |
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The PROMIS short form 6a for sleep disturbance uses fixed items from the PROMIS sleep disturbance item bank to provide a T-score with population mean = 50 (sd=10). |
| From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments) |
| 3-PEG Scale | 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) | From enrollment to the end of the surveillance period (26 and 52 weeks) |
| PROMIS Depression | The PROMIS short form 6a for depression uses fixed items from the PROMIS depression item bank to provide a T-score with population mean = 50 (sd=10). | From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments) |
| PROMIS Fatigue | The PROMIS short form 6a for fatigue uses fixed items from the PROMIS fatigue item bank to provide a T-score with population mean = 50 (sd=10). | From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments) |
| PROMIS Prescription Medication Misuse | The PROMIS short form 7a assesses the abuse of prescription pain medication over a 3-month period. The short form uses fixed items from the PROMIS item bank to provide a T-score with population mean = 50 (sd=10). | From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments) |
| Sleep Duration | Sleep duration is assessed through a single item question that comes from the Pittsburgh Sleep Quality Index (PSQI): "During the past month, how many hours and minutes of actual sleep did you get at night? (This may be different than the number of hours and minutes you spent in bed)." | From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments) |
| Pain Catastrophizing Scale (PCS) | The PCS is a 13-item scale assessing the extent to which people catastro-phize in response to pain. Each item is scored from 0-4 providing an overall score from 0-52. | From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments) |
| Pain Self-Efficacy Scale (PSEQ) | The PSEQ is a 4-item scale assessing a person's confidence to achieve goals and perform activities even with pain. Each item is scored from 0-6 for an overall score ranging from 0-60. | From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments) |
| Desmond Doss Health Clinic | Recruiting | Schofield Barracks | Hawaii | 96786 | United States |
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| Brooke Army Medical Center | Recruiting | San Antonio | Texas | 78219 | United States |
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| Wilford Hall Ambulatory Surgical Center | Not yet recruiting | San Antonio | Texas | 78236 | United States |
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| Madigan Army Medical Center | Not yet recruiting | Tacoma | Washington | 98391 | United States |
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| 22553896 | Background | 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/ |
| Background | Department of Veterans Affairs. Veterans' Health Administration. Pain Management, VHA Directive 2009-053. October 28, 2009. Published 2009. Accessed August 25, 2023. |
| 24978399 | Background | 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. |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D059352 | Musculoskeletal Pain |
| D003095 | Collagen Diseases |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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