NCT05097521

Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health

Complementary and Integrative Health for Pain in the VA: A National Demonstration Project (NIH-VA-DOD Joint Initiative)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,726 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Musculoskeletal Pain

Interventions

Type	Name	Description
OTHER	Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings	Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings
OTHER	Self-care CIH therapies (yoga, Tai Chi/Qigong , meditation) as received in VHA and community practice settings	Self-care CIH therapies (yoga, Tai Chi/Qigong , meditation) as received in VHA and community practice settings
OTHER	Combination of practitioner-delivered and self-care CIH therapies (described above) as received in VHA and community practice settings	Combination of practitioner-delivered and self-care CIH therapies (described above) as received in VHA and community practice settings

Timeline

• Start date: 2021-03-17
• Primary completion: 2023-09-17
• Completion: 2023-09-17
• First posted: 2021-10-28
• Last updated: 2024-04-22

Locations

2 sites across 1 country: United States