Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coaching.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Musculoskeletal Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
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.).
Interventions
- 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).
Primary outcome measures
- Recruitment (number enrolled out of all eligible and asked to participate) [Time frame: Baseline]
- Retention (number who complete intervention and outcomes at post-intervention out of all enrolled) [Time frame: 3 Months (primary) and 6 Months]
Secondary outcome measures (4)
- Feasibility of Intervention Measure (scale) [Time frame: 3 Months]
- Acceptability of Intervention Measure (scale) [Time frame: 3 Months]
- Intervention Appropriateness Measure (scale) [Time frame: 3 Months]
- Pain intensity and interference [Time frame: Baseline, 3 Months, 6 Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
Identifiers
NCT: NCT07456150 · RRD9-011-25M · 25-2658