Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment (number enrolled out of all eligible and asked to participate)
研究概览
简要总结
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).
详细描述
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.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Coaching (Behavioral)
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).
结局指标
主要结局
Recruitment (number enrolled out of all eligible and asked to participate)
时间窗: 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)
时间窗: 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)
次要结局
- Feasibility of Intervention Measure (scale)(3 Months)
- Acceptability of Intervention Measure (scale)(3 Months)
- Intervention Appropriateness Measure (scale)(3 Months)
- Pain intensity and interference(Baseline, 3 Months, 6 Months)