Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care

Half of all Veterans who seek care from the Veterans Health Administration (VHA) experience chronic musculoskeletal pain. First-line treatment for chronic pain should include nonpharmacological interventions. Although Veterans have access to these interventions, there is no standardized process to personalize them to meet the needs of individual Veterans despite the fact that personalization and self-care are key components of the VHA's Stepped Care Model for pain management. This proposal seeks to adapt and evaluate a coaching intervention that will be a personalized approach to help Veterans develop and maintain pain self-care plans. The proposed research responds to VHA's strategic objectives to tailor service delivery (obj. 2.2) and develop or adapt interventions that improve Veteran outcomes (obj. 2.4).

Study Overview

• Status: Not yet recruiting
• Conditions: Musculoskeletal Pain; Chronic Pain
• Intervention / Treatment: Behavioral: Coaching

Detailed Description

The overall purpose of this research is to design and test an intervention that will support Veterans in developing and maintaining a self-care plan for chronic pain. This study will use a multi-stage mixed methods intervention development and optimization design. The first stage (Aim 1) is a convergent mixed methods design that incorporates traditional qualitative, human-centered design, and quantitative methods to discover Veteran and clinician preferences and recommendations for an intervention to support personalization and maintenance of pain self-care plans. The second stage (Aim 2) uses human-centered design methods to engage with multiple key partners (Veterans, clinicians, leadership, etc.) to iterative design the intervention. The final stage (Aim 3) is a convergent mixed-methods design that will test the intervention among Veterans with chronic pain. Aim 3 will evaluate the feasibility and acceptability of the intervention using a randomized feasibility study with 2 parallel arms (n=15/arm). The primary feasibility outcomes are recruitment and retention; secondary outcomes will evaluate willingness of participants to be randomized, acceptability of the intervention, and changes in Veteran-level outcomes (pain interference, quality of life, etc.).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michelle R Rauzi, DPT; Phone Number: (208) 630-4002; Email: michelle.rauzi@va.gov
• Study Contact Backup: Name: Joseph W Frank, MD MPH; Phone Number: (720) 857-2784; Email: joseph.frank2@va.gov

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045-7211
      • Rocky Mountain Regional VA Medical Center, Aurora, CO
      • Contact: Michelle R Rauzi, DPT; Phone Number: 208-630-4002; Email: michelle.rauzi@va.gov
      • Principal Investigator: Michelle R Rauzi, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• U.S. military Veteran
• Chronic musculoskeletal pain defined by the National Health Interview Survey (pain that has been present on most days for the past 3 months)

Exclusion Criteria:

• Moderate to Severe cognitive impairment
• Severe or untreated substance use disorder
• Severe or untreated mental health condition
• Enrolled in hospice or palliative care with life expectancy <12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants randomized to the Intervention arm will receive the intervention for developing and maintaining a personalized pain self-care plan. The intervention is anticipated to be a coaching program that will last for about 3 months; specific details of the intervention will be updated prior to enrollment.	Behavioral: Coaching; The intervention will likely incorporate health coaching to support participants in developing and maintaining their pain self-care plans. Details of the intervention will be updated prior to enrollment because the core components may changed based on findings from stages 1 and 2 (aims 1 and 2).
No Intervention: Control; Participants randomized to the Control arm will receive advise to continue with their planned medical care and daily activities. Specific details and the type of comparator arm will be updated prior to enrollment because these may changed based on key partner findings in stages 1 and 2 (aims 1 and 2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment (number enrolled out of all eligible and asked to participate)	Recruitment rate is defined as the proportion of Veterans who enroll in the feasibility study out of all those eligible who were asked to participate.	Baseline
Retention (number who complete intervention and outcomes at post-intervention out of all enrolled)	Retention is defined as the proportion of Veterans who complete the intervention (anticipated timeframe of 3 months) and the proportion who complete the post-intervention outcomes (anticipated 3 months) and follow-up outcomes (anticipated 6 months)	3 Months (primary) and 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intervention Measure (scale)	The Feasibility of Intervention Measure consists of 4 items rated on a 5-point Likert scale from (1) complete disagree to (5) completely agree. Mean scores are reported and can range from 1 to 5. Higher scores indicate greater feasibility of the program. Feasibility will be evaluated post-program (anticipated 3 months).	3 Months
Acceptability of Intervention Measure (scale)	The Acceptability of Intervention Measure consists of 4 items rated on a 5-point Likert scale from (1) complete disagree to (5) completely agree. Mean scores are reported and can range from 1 to 5. Higher scores indicate greater acceptability of the program. Feasibility will be evaluated post-program (anticipated 3 months).	3 Months
Intervention Appropriateness Measure (scale)	The Intervention Appropriateness Measure consists of 4 items rated on a 5-point Likert scale from (1) complete disagree to (5) completely agree. Mean scores are reported and can range from 1 to 5. Higher scores indicate greater appropriateness of the program. Feasibility will be evaluated post-program (anticipated 3 months).	3 Months
Pain intensity and interference	Pain intensity and interference will be measured by the PEG-3 (Pain intensity, interference with Enjoyment of life, and interference with General activity) scale. The PEG-3 is a 3-item measure that is valid for individuals with chronic pain and is sensitive to change. Mean of the three individual item scores are reported and can range from 0 to 10. Lower scores indicated less pain intensity and interference.	Baseline, 3 Months, 6 Months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Michelle R Rauzi, DPT, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2029
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Veterans; Coaching; Self Care; Human-centered Design
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Musculoskeletal Pain; Chronic Pain
• Other Study ID Numbers: RRD9-011-25M; 25-2658 (Other Grant/Funding Number: COMIRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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