Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health (APPROACH)

April 13, 2026 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 three study groups - Veterans Using Practitioner Delivered CIH Therapies Only, Veterans Using Self-Care CIH Therapies Only, or Veterans Using a Combination of Practitioner-Delivered and Self-Care CIH Therapies (Dual-Care) - 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 groups, similar to the use of randomization, is to reduce potential selection and confounding bias. The six-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.

The APPROACH study was initially envisioned to examine primary and secondary outcomes for the above-named three study groups. Due to the study's pragmatic design and sampling approach, the sample size of the Veterans Using Self-Care CIH Therapies Only group did not meet the minimum threshold necessary to detect between-group differences of interest. It was therefore determined that study revisions would be necessary.

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 VA Office of Patient Centered Care and Cultural Transformation's Complementary and Integrative Health Therapy Patient Experience Survey: The APPROACH study is predominately conducting a secondary analysis of patient-reported data being collected by VA OPCC&CT's four timepoint survey (baseline and months 1, 3, 6). Almost all of the outcomes listed below are from that survey.

Study Type

Observational

Enrollment (Actual)

3603

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sepulveda, California, United States, 91343
        • VA Greater Los Angeles Healthcare System, Sepulveda, CA
    • Washington
      • Seattle, Washington, United States, 98108-1532
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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
  • Aged 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Veterans using self-care CIH therapies only
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only
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
Veterans using a combination of practitioner-delivered and self-care CIH therapies (dual-care)
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
Veterans using practitioner-delivered CIH therapies only
Other: Practitioner-delivered CIH therapies
Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory (BPI) Severity Scale
Time Frame: Change from baseline to 6 months
Measure of pain severity. Scores range from 0-10, with higher scores indicating more severe pain.
Change from baseline to 6 months
Brief Pain Inventory (BPI) Interference Scale
Time Frame: Change from baseline to 6 months
Measure of pain-related functional interference. Scores range from 0-10, with higher scores indicating greater pain-related functional interference.
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
Time Frame: 6 months
Single-item scale which assesses how much a patient perceives their pain has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse pain outcomes following the specified intervention.
6 months
Patient Global Impression of Change (PGIC) for Improvement in Mental Health
Time Frame: 6 months
Single-item scale which assesses how much a patient perceives their mental health has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse mental health outcomes following the specified intervention.
6 months
Patient Global Impression of Change (PGIC) for Improvement in Fatigue
Time Frame: 6 months
Single-item scale which assesses how much a patient perceives their fatigue has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse fatigue outcomes following the specified intervention.
6 months
Patient Global Impression of Change (PGIC) for Improvement in Overall Well-being
Time Frame: 6 months
Single-item scale which assesses how much a patient perceives their overall well-being has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse overall well-being outcomes following the specified intervention.
6 months
PROMIS10 Global Assessment of Physical Health
Time Frame: Change from baseline to 6 months

Assesses physical function, fatigue, pain, and social health; score derived from the PROMIS10 Global Health measure which assesses physical and mental health and generates two summary scores: Global Physical Health and Global Mental Health.

Scores are reported on a T-score metric wherein the mean score of the general population is standardized to 50 with a standard deviation of 10. A score of 50 indicates average physical health, as compared to the general population. Higher scores indicate better physical health.
Change from baseline to 6 months
PROMIS10 Global Assessment of Mental Health
Time Frame: Change from baseline to 6 months

Assesses emotional distress and mental health; score derived from the PROMIS10 Global Health measure which assesses physical and mental health and generates two summary scores: Global Physical Health and Global Mental Health.

Scores are reported on a T-score metric wherein the mean score of the general population is standardized to 50 with a standard deviation of 10. A score of 50 indicates average mental health, as compared to the general population. Higher scores indicate better mental health.
Change from baseline to 6 months
Life Engagement Test (LET)
Time Frame: Change from baseline to 6 months
6 items are rated on a 5-point Likert scale ranging from 1 to 5. Scores range from 6 to 30, with higher scores indicating better life engagement/purpose in life.
Change from baseline to 6 months
Perceived Stress Scale (PSS-4)
Time Frame: Change from baseline to 6 months
Measure of perceived stress consisting of 4 items which are each rated on a 5-point scale ranging from 0 to 4. Scores range from 0 to 16, with higher scores indicating greater perceived stress.
Change from baseline to 6 months
Patient Health Questionnaire (PHQ2)
Time Frame: Change from baseline to 6 months
Measure of depressed mood and anhedonia consisting of 2 items which are each rated on a 7-point scale ranging from 0 to 6. Scores range from 0 to 12, with higher scores indicating more depressive symptoms.
Change from baseline to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Health Competency Scale (PHCS-2)
Time Frame: Change from baseline to 6 months
2-item measure of perceived health competency with each item rated on a 5-point scale from 1 to 5. Scores range from 2 to 10, with higher scores indicating greater perceived health competency.
Change from baseline to 6 months
Altarum Consumer Engagement (ACE)
Time Frame: Change from baseline to 6 months
Altarum Consumer Engagement/Ownership Subscale measures perceived role in and responsibility for one's health. Scores range from 5-25, with higher scores indicating greater responsibility and ownership.
Change from baseline to 6 months
Self-Efficacy for Managing Chronic Disease (SEMCD)
Time Frame: Change from baseline to 6 months
Items 5 and 6 from the 6-item Self-Efficacy for Managing Chronic Disease (SEMCD) scale with each item rated on a scale of 1 to 10. Scored as the 2-item mean, with higher scores indicating greater self-efficacy.
Change from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Veterans Health Administration Office of Patient Centered Care & Cultural Transformation

Investigators

  • Principal Investigator: Steven B. Zeliadt, PhD MPH, VA Puget Sound Health Care System Seattle Division, Seattle, WA
  • Principal Investigator: Stephanie L Taylor, PhD MPH, VA Greater Los Angeles Healthcare System, Sepulveda, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

September 17, 2023

Study Completion (Actual)

September 17, 2023

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR 17-306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The United States Department of Veterans Affairs (VA) places legal restrictions on access to Veteran's health care data, which includes both identifiable and de-identified data, and sensitive patient information. The datasets generated and analyzed in this study are derived from two primary data sources: The Veterans Health Administration (VHA) Corporate Data Warehouse and the VHA Office of Patient Centered Care and Cultural Transformation's Complementary and Integrative Health Therapy Patient Experience Survey. As they are secondary analyses, study data will not be made available to others. However, programming code generated by this study is available by author request to facilitate reproducibility of study findings by supporting the extraction and transformation of identical data from VA data sources.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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