Clinical trial NCT05097521: Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health
Official title: Complementary and Integrative Health for Pain in the VA: A National Demonstration Project (NIH-VA-DOD Joint Initiative)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Musculoskeletal Pain
Keywords: Complementary Therapies
Chronic Pain
Integrative Medicine
Chiropractic
Acupuncture
Yoga
Tai Chi
Meditation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Veterans Health Administration Office of Patient Centered Care & Cultural Transformation
First posted: 2021-10-28
Enrollment: 3726
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe chronic musculoskeletal pain who initiate at least one of the six CIH therapies at the 18 VA Whole Health flagship study sites during the study period who also participate in the VA Office of Patient Centered Care and Cultural Transformations CIH Experience Survey.

Brief summary: The APPROACH Study (Assessing Pain, Patient-Reported Outcomes and Complementary and Integrative Health) assesses the effects of use of practitioner-delivered CIH therapies alone compared to the combination of self-care and practitioner-delivered CIH therapies among Veterans with chronic musculoskeletal pain. The APPROACH study is predominately conducting a secondary analysis of patient-reported data being collected by the Veterans Health Administration's (VA) Office of Patient Centered Care and Cultural Transformation among Veterans using 18 VA medical centers. Those facilities received funding as part of the Comprehensive Addiction and Recovery Act to expand availability of CIH therapies. That patient-reported data is being supplemented with VA electronic health record data and data on the 18 medical centers' business practices (nudges, the instrumental variable). Practitioner-delivered therapies under study include chiropractic care, acupuncture and therapeutic massage, and self-care therapies include Tai Chi/qigong, yoga and meditation. The primary outcomes are improvement in pain severity and pain interference, using the Brief Pain Inventory (BPI), 6 months after initiating CIH therapies compared to baseline. Patients will enter treatment groups based on the CIH therapies they use, as randomizing patients to specific therapies would require withholding therapies routinely offered at VA. The investigators will address selection bias and confounding by using sites' variations in business practices and other encouragements (nudges) to receiving different CIH therapies as a surrogate for direct randomization using instrumental variables econometric methods.

Detailed description: Design: The investigators are employing a quasi-experimental encouragement study design in which subjects are able to choose their own CIH therapies, but some are offered extra encouragements (nudges) to choose specific CIH therapies. Instead of being randomized to a CIH therapy, individuals will enter one of the two study groups based on what CIH therapies they used six months after they initiate any CIH therapy. Although accrual to study group is not random, some sites have strong business practices/nudges that lead to considerable variation in which CIH therapies patients use. The variation induced by these business practices/nudges provides a quasi-experimental natural experiment that can be assessed through an instrumental variables analytic approach. The purpose of using business practices as an instrument for accruing patients to treatment group, similar to the use of randomization, is to reduce potential selection and confounding bias. The 6-month treatment window will allow for patients to initiate one type of CIH therapy and add additional CIH therapies based on business practices/nudges at their site within the evaluation period. The CIH therapies that patients receive will be as they are delivered by the 18 VHA Whole Health flagship study sites and community care practices.

Sites: The study sites are the VA's 18 Whole Health Flagship sites: VA Boston Health Care System, VA New Jersey Health Care System, Erie VAMC, Beckley VAMC, W. G. (Bill) Hefner VAMC, Atlanta VAMC, Tampa VAMC, Tennessee Valley Health Care System, Aleda E. Lutz VAMC, Tomah VAMC, St. Louis VA Health Care System, Central Arkansas Veterans Healthcare System, South Texas Veterans Health Care System, Salt Lake City VAMC, VA Portland Health Care System, Palo Alto VAMC, Tucson VAMC, VA Nebraska-Western Iowa Health Care System).

Secondary Data from the CIH Experience Survey/ VA Office of Patient Centered Care and Cultural Transformation's Survey: The APPROACH study is predominately conducting a secondary analysis of patient-reported data being collected by VA OPCC\&CT's survey. That is a 4-time point survey (baseline and months 1, 3, 6). Almost all of the outcomes listed below are from that survey.

Eligibility criteria: Inclusion Criteria:

* Veteran
* History of (chronic) musculoskeletal-related pain conditions recorded in the EHR in the year prior to the index visit, and self-report pain present every day or nearly every day for 3 months from the CIH index visit using an eligibility screener
* 18-89 on index CIH visit date

Exclusion Criteria:

* diagnoses of serious mental illness in the year prior to initiating CIH
* history of spinal cord injury
* hospitalization 30 days prior to initiating CIH
* recorded CIH use in the EHR in the 6 months prior to the index CIH visit and reported CIH use in the 8 weeks prior to index CIH visit

Primary outcomes:
measure: Brief Pain Inventory Interference Scale
timeFrame: Change from baseline to 6 months
measure: Brief Pain Inventory Severity Scale
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC) for improvement in pain
timeFrame: baseline, 1 month, 3 months, and 6 months
measure: Patient Global Impression of Change (PGIC) for improvement in mental health
timeFrame: 6 months
measure: Patient Global Impression of Change (PGIC) for improvement in physical health
timeFrame: 6 months
measure: Patient Global Impression of Change (PGIC) for improvement in fatigue
timeFrame: 6 months
measure: Patient Global Impression of Change (PGIC) for improvement in overall well-being
timeFrame: 6 months
measure: PROMIS10 global assessment of physical health
timeFrame: Change from baseline to 6 months
measure: PROMIS10 global assessment of mental health
timeFrame: Change from baseline to 6 months
measure: PROMIS10 assessment of fatigue
timeFrame: Change from baseline to 6 months
measure: PROMIS10 assessment of general quality of life
timeFrame: Change from baseline to 6 months
measure: Life Engagement Test (LET)
timeFrame: Change from baseline to 6 months
measure: Perceived Stress Scale (PSS-4)
timeFrame: Change from baseline to 6 months
measure: Patient Health Questionnaire (PHQ2)
timeFrame: Change from baseline to 6 months
Other outcomes:
measure: Perceived Health Competency Scale (PHCS-2)
timeFrame: Change from baseline to 6 months
measure: Altarum Consumer Engagement (ACE)
timeFrame: Change from baseline to 6 months
measure: Self-Efficacy for Managing Chronic Disease (SEMCD)
timeFrame: Change from baseline to 6 months
Locations:
city: Sepulveda
country: United States
facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA
state: California
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, Sepulveda, CA
name: Stephanie L Taylor, PhD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Steven B. Zeliadt, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeliadt SB, Coggeshall S, Thomas E, Gelman H, Taylor SL. The APPROACH trial: Assessing pain, patient-reported outcomes, and complementary and integrative health. Clin Trials. 2020 Aug;17(4):351-359. doi: 10.1177/1740774520928399. Epub 2020 Jun 10.
citation: 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 Med. 2020 Dec 12;21(Suppl 2):S100-S109. doi: 10.1093/pm/pnaa349.
citation: 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. Mil Med. 2022 Jul 1;187(7-8):179-185. doi: 10.1093/milmed/usab458.
citation: 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. Telemed J E Health. 2023 Apr;29(4):576-583. doi: 10.1089/tmj.2022.0209. Epub 2022 Jul 22.
citation: 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. J Pain. 2023 Apr;24(4):568-574. doi: 10.1016/j.jpain.2022.12.008. Epub 2022 Dec 24.