BACKGROUND/RATIONALE:
Over half of Veterans report musculoskeletal pain, often with mental health comorbidities. Complementary and integrative health (CIH) therapies are important non-pharmacologic treatment options for these conditions. Practitioner-delivered therapies (i.e., acupuncture or chiropractic) are promising, but providers would like patients to be more active in their pain management by using self-care (i.e., meditation, tai chi, yoga) instead of relying on practitioner-delivered care. A critical question for the field is whether adding self-care CIH to practitioner-delivered CIH is a more effective approach than either strategy alone. However, we are unaware of anyone examining this. Also, to-date, studying CIH in large VA samples has been difficult because few facilities capture CIH use with codes in their electronic health records, and very few use the VA's standardized codes, preventing multi-site studies.

OBJECTIVE(S):
The APPROACH Trial is a large-scale (n=18,000) pragmatic comparative effectiveness clinical trial to assess the effectiveness of practitioner-delivered CIH (acupuncture, massage) combined with self-care (yoga, tai chi, mindfulness) CIH versus either practitioner-delivered or self-care alone among Veterans with chronic musculoskeletal pain. It aims to improve Veterans pain, several pain-related comorbid conditions, and opioid use. The study is being conducted in partnership with the VA Office of Patient Centered Care and Cultural Transformation

METHODS:
Planning Phase (UG3): The goals of this phase are to understand 1) the reliability of OPCC&CT's patient reported outcome measurement effort, 2) the natural variation in utilization of the five CIH therapies, 3) the predictors of utilization to help design the marketing "nudges", and 4) to determine from our expert panel and the literature how best to measure and assess the effects of CIH. Specifically, as the 18 sites begin implementing CIH, we will evaluate data collection instruments and processes that OPCC&CT is implementing to capture CIH use and patient reported outcomes (the intended outcomes for the trial) and record in the electronic medical records. OPCC&CT will be instructing sites to collect data on 1) pain and its intensity and interference, using the PEG measure, and, using the PROMISE10 measure, 2) global physical and mental health and 3) fatigue. We also will conduct preliminary descriptive analyses of the amount of CIH being used at each location. This information will be used to design a subsequent 4-year pragmatic trial of CIH building on OPCC&CT's initial implementation effort.

Trial/Implementation Phase (UH3): We will conduct a 3-arm pragmatic trial using an encouragement design to assess the longitudinal comparative effectiveness of: 1) practitioner-delivered care (acupuncture or chiropractic care) combined with self-care (Tai Chi, meditation/mindfulness or yoga) compared to 2) practitioner-delivered care alone or 3) self-care alone. We will examine outcomes at 3 and 6 months for OPCC&CT's target sample of 18,000 CIH users. We will use randomized "nudges" (e.g., educational brochures with class listings) tailored to each site to encourage Veterans who use one type of CIH to consider a combination of therapies.

FINDINGS/RESULTS:
There are no findings to report to date.

IMPACT:
This study will be the first large-scale examination of the effects of CIH use on pain and comorbid outcomes among Veterans and examines the question of the effectiveness of practitioner-delivered CIH in combination with or instead of CIH self-care, which is a priority question for VA and other healthcare systems with limited resources implementing CIH programs.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Zeliadt SB, Coggeshall S, Gelman H, Shin MH, Elwy AR, Bokhour BG, Taylor SL. Assessing the Relative Effectiveness of Combining Self-Care with Practitioner-Delivered Complementary and Integrative Health Therapies to Improve Pain in a Pragmatic Trial. Pain medicine (Malden, Mass.). 2020 Dec 12; 21(Suppl 2):S100-S109. [view]
2. Kerns RD, Davis AF, Fritz JM, Keefe FJ, Peduzzi P, Rhon DI, Taylor SL, Vining R, Yu Q, Zeliadt SB, George SZ. Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence. The journal of pain. 2023 Apr 1; 24(4):568-574. [view]
3. Ali J, Antonelli M, Bastian L, Becker W, Brandt CA, Burgess DJ, Burns A, Cohen SP, Davis AF, Dearth CL, Dziura J, Edwards R, Erdos J, Farrokhi S, Fritz J, Geda M, George SZ, Goertz C, Goodie J, Hastings SN, Heapy A, Ilfeld BM, Katsovich L, Kerns RD, Kyriakides TC, Lee A, Long CR, Luther SL, Martino S, Matheny ME, McGeary D, Midboe A, Pasquina P, Peduzzi P, Raffanello M, Rhon D, Rosen M, Esposito ER, Scarton D, Hastings SN, Seal K, Silliker N, Taylor S, Taylor SL, Tsui M, Wright FS, Zeliadt S. Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory. Military medicine. 2022 Jul 1; 187(7-8):179-185. [view]
4. Der-Martirosian C, Shin M, Upham ML, Douglas JH, Zeliadt SB, Taylor SL. Telehealth Complementary and Integrative Health Therapies During COVID-19 at the U.S. Department of Veterans Affairs. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2023 Apr 1; 29(4):576-583. [view]
5. Zeliadt SB, Coggeshall S, Thomas E, Gelman H, Taylor SL. The APPROACH trial: Assessing pain, patient-reported outcomes, and complementary and integrative health. Clinical trials (London, England). 2020 Aug 1; 17(4):351-359. [view]

Reports

1. Zeliadt SB. Department of Veteran Affairs VA Pilot Program on the Integration of Complementary and Integrative Health and Well-being Programs. In accordance with the requirements of section 933 of Public Law 114-198, enclosed is the 30-month progress report on implementation of Complementary and Integrative Health (CIH) and Whole Health at the 18 flagship sites after 2 years of the pilot program. The required cost analysis is also enclosed.. Washington, DC: Department of Veterans Affairs; 2020 Mar 31. 1-29 p. [view]

DRA: Musculoskeletal Disorders
DRE: TRL - Applied/Translational
Keywords: Complementary and Alternative Practices, Pain
MeSH Terms: none