Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health

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 receiving care at one of 18 VA medical centers. Those 18 facilities received funding to expand availability of CIH therapies as part of the Comprehensive Addiction and Recovery Act of 2016. 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; self-care therapies include Tai Chi/Qigong, yoga, and meditation. The primary outcomes are improvement in pain severity and pain interference, assessed using the Brief Pain Inventory (BPI), six 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.

Conditions

• Chronic Musculoskeletal Pain

Interventions

OTHER

Combination of practitioner-delivered and self-care CIH therapies

Combination of practitioner-delivered (acupuncture, therapeutic massage, chiropractic care) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies as received in VHA and community practice settings

OTHER

Self-care CIH therapies

Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings

OTHER

Practitioner-delivered CIH therapies

Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings

Sponsors & Collaborators

• Veterans Health Administration Office of Patient Centered Care & Cultural Transformation

  collaborator UNKNOWN

• VA Office of Research and Development

  lead FED

Principal Investigators

• Stephanie L Taylor, PhD MPH · VA Greater Los Angeles Healthcare System, Sepulveda, CA

• Steven B. Zeliadt, PhD MPH · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-17

Primary Completion

2023-09-17

Completion

2023-09-17

Countries

• United States

Study Locations