Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health

Chronic Musculoskeletal Pain Clinical Trial

— APPROACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097521
• Other study ID #: SDR 17-306
• Status: Completed
• Start date: March 17, 2021
• Est. completion date: September 17, 2023

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3726
• Est. completion date: September 17, 2023
• Est. primary completion date: September 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Musculoskeletal Pain
• Musculoskeletal Pain

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington
United States	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Veterans Health Administration Office of Patient Centered Care & Cultural Transformation

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived Health Competency Scale (PHCS-2)	Items are rated on a five-point scale with higher scores indicating lower perceived health competency.	Change from baseline to 6 months
Other	Altarum Consumer Engagement (ACE)	Items are rated on a five-point scale with higher scores indicating lower patient engagement.	Change from baseline to 6 months
Other	Self-Efficacy for Managing Chronic Disease (SEMCD)	Items are rated on a ten-point scale with higher scores indicating higher self-efficacy. Only items 5 and 6 are included in the survey.	Change from baseline to 6 months
Primary	Brief Pain Inventory Interference Scale	Measure of pain-related functional interference. Scores range 0-10; higher score is worse.	Change from baseline to 6 months
Primary	Brief Pain Inventory Severity Scale	Measure of pain intensity. Scores range 0-10; higher score is worse.	Change from baseline to 6 months
Secondary	Patient Global Impression of Change (PGIC) for improvement in pain	Scores range 1-5; 1=much better, 5 = much worse.	baseline, 1 month, 3 months, and 6 months
Secondary	Patient Global Impression of Change (PGIC) for improvement in mental health	Scores range 1-5; 1=much better, 5 = much worse.	6 months
Secondary	Patient Global Impression of Change (PGIC) for improvement in physical health	Scores range 1-5; 1=much better, 5 = much worse.	6 months
Secondary	Patient Global Impression of Change (PGIC) for improvement in fatigue	Scores range 1-5; 1=much better, 5 = much worse.	6 months
Secondary	Patient Global Impression of Change (PGIC) for improvement in overall well-being	Scores range 1-5; 1=much better, 5 = much worse.	6 months
Secondary	PROMIS10 global assessment of physical health	Items are rated on a five-point scale with higher scores indicating better health.	Change from baseline to 6 months
Secondary	PROMIS10 global assessment of mental health	Items are rated on a five-point scale with higher scores indicating better health.	Change from baseline to 6 months
Secondary	PROMIS10 assessment of fatigue	Items are rated on a five-point scale with higher scores indicating better health.	Change from baseline to 6 months
Secondary	PROMIS10 assessment of general quality of life	Items are rated on a five-point scale with higher scores indicating better health.	Change from baseline to 6 months
Secondary	Life Engagement Test (LET)	Items are rated on a five-point scale with higher scores indicating better life engagement.	Change from baseline to 6 months
Secondary	Perceived Stress Scale (PSS-4)	Items are rated on a five-point scale with higher scores indicating more perceived stress.	Change from baseline to 6 months
Secondary	Patient Health Questionnaire (PHQ2)	Measure of depressed mood and anhedonia. Scores range from 0 to 6, with higher scores indicating more depressive symptoms.	Change from baseline to 6 months