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

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.).

• Coaching (Behavioral): 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 outcomes

• Recruitment (number enrolled out of all eligible and asked to participate) [Baseline]: 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.
• Retention (number who complete intervention and outcomes at post-intervention out of all enrolled) [3 Months (primary) and 6 Months]: 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)

Secondary outcomes

• Feasibility of Intervention Measure (scale) [3 Months]: 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).
• Acceptability of Intervention Measure (scale) [3 Months]: 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).
• Intervention Appropriateness Measure (scale) [3 Months]: 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).
• Pain intensity and interference [Baseline, 3 Months, 6 Months]: 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.

Sex: All, ages: 18 Years to any

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

• Michelle R Rauzi, DPT, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO