Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Musculoskeletal Pain

Intervention / Treatment
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* Other: 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
* Other: Combination of practitioner-delivered and self-care CIH therapies (described above) as received in VHA and community practice settings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Veterans using practitioner delivered CIH therapies only<br>Veterans using practitioner-delivered (acupuncture, chiropractic care, massage) CIH therapies only | Other: Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings<br>* Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings<br>|
| Veterans using self-care CIH therapies only<br>Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only | Other: Self-care CIH therapies (yoga, Tai Chi/Qigong , meditation) as received in VHA and community practice settings<br>* Self-care CIH therapies (yoga, Tai Chi/Qigong , meditation) as received in VHA and community practice settings<br>|
| Veterans using a combination of practitioner-delivered and self-care CIH therapies (dual-care)<br>Veterans using a combination of practitioner-delivered and self-care CIH therapies (dual-care) | Other: Combination of practitioner-delivered and self-care CIH therapies (described above) as received in VHA and community practice settings<br>* Combination of practitioner-delivered and self-care CIH therapies (described above) as received in VHA and community practice settings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Brief Pain Inventory Severity Scale | Measure of pain intensity. Scores range 0-10; higher score is worse. | Change from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Patient Global Impression of Change (PGIC) for improvement in mental health | Scores range 1-5; 1=much better, 5 = much worse. | 6 months | 
| Patient Global Impression of Change (PGIC) for improvement in physical health | Scores range 1-5; 1=much better, 5 = much worse. | 6 months | 
| Patient Global Impression of Change (PGIC) for improvement in fatigue | Scores range 1-5; 1=much better, 5 = much worse. | 6 months | 
| Patient Global Impression of Change (PGIC) for improvement in overall well-being | Scores range 1-5; 1=much better, 5 = much worse. | 6 months | 
| 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 | 
| 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 | 
| PROMIS10 assessment of fatigue | Items are rated on a five-point scale with higher scores indicating better health. | Change from baseline to 6 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complementary Therapies, Chronic Pain, Integrative Medicine, Chiropractic, Acupuncture, Yoga, Tai Chi, Meditation