Comparing Strategies to Improve Non-Pharmacologic Pain Relief for Adults With Back Pain (The ENCompaSS Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score
研究概览
简要总结
The goal of this clinical trial is to help veterans manage high-impact chronic pain (HICP) in the lower back. The trial will use a program, ENCompaSS (Education, Navigated Care, and Supported Self-Management) designed to reduce pain more than usual care alone. Researchers will assess a) the impact of ENCompaSS, b) identify which veterans benefit the most, and c) how this program can be delivered more broadly in other clinics and health systems.
What Will Happen:
Veterans in this clinical trial will be randomly placed into one of two groups.
ENCompaSS group (intervention):
- Have at least three phone calls with a trained clinician over about 12 weeks
- Watch short online videos about managing pain
- Complete surveys before the study and again at 2, 4, 6, and 12 months
Usual Stepped Care group:
- Will continue with regular care
- Complete the same surveys at the same time points
详细描述
ENCompaSS (Education, Navigated Care, and Supported Self-Management), is a type 1 hybrid effectiveness-implementation trial conducted within three Veterans Heath Administration (VHA) systems. The intervention is a patient-centered, navigator-assisted program designed to inform and guide Veterans on non-pharmacologic treatment options.
The total study duration, including enrollment and follow-up, is approximately 30 months. A total of 530 veterans with high-impact chronic pain (HICP) due to low back pain (LBP) will be enrolled and randomized in a 1:1 ratio to receive either the ENCompaSS intervention or usual stepped care within the VA health system. In keeping with the pragmatic design, participating VHA sites will receive standardized training and implementation support but will deliver the intervention using their existing clinical staff and resources.
Patient-reported outcomes will be collected via telephone-administered Research Electronic Data Capture (REDCap) surveys at baseline and at 2, 4, 6, and 12 months post-randomization. The primary outcome will be assessed at 6 months, with additional follow-up to evaluate longer-term effects 12 months post randomization.
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
- Single (Outcomes Assessor)
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
- •Be age 18 years old or older
- •Have a VA outpatient clinic visit for low back pain within the previous 30 days
- •Be enrolled in a participating primary care clinic
- •Have high impact chronic pain per Graded Chronic Pain Scale (most days or every day on first 2 items)
- •Valid telephone access
- •Ability to provide informed consent
排除标准
- •Are currently hospitalized or residing in a nursing home
- •Have cognitive impairment or lack of decision-making capacity
- •Have a serious mental illness (e.g., schizophrenia, bipolar disorder, recent psychiatric hospitalization, high risk suicide flag)
- •Are unable to communicate by telephone or have no telephone access
结局指标
主要结局
Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score
时间窗: From enrollment to 6 Months
The validated PROMIS Pain Interference instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical, and recreational activities. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates greater pain interference.
次要结局
- Sleep quality assessed by the PROMIS 4-item short form(Baseline to 6 Months)
- Physical function assessed by the PROMIS 4-item short form(Baseline to 6 Months)
- Pain intensity assessed by the PROMIS short form(Baseline to 6 Months)
- Depression assessed by the PROMIS 4-item short form(Baseline to 6 Months)
- Anxiety assessed by the PROMIS 4-item short form(Baseline to 6 Months)
- Pain-related ED visits by the VA electronic health record (EHR)(12 Months post randomization)
- Non-pharmacologic pain care visits by the VA EHR(6 Months and 12 Months post randomization)
- Average Self-Reported Endorsement of Depression Symptoms(Baseline to 6 Months)
- Average Self-Reported Pain Intensity Ratings(Baseline to 6 Months)
- Average Ratings of Self-Reported Sleep Quality(Baseline to 6 Months)
- Average Ratings of Self-Reported Physical Function(Baseline to 6 Months)
- Average Self-Reported Endorsement of Anxiety Symptoms(Baseline to 6 Months)
- Number of Pain-Related Emergency Department (ED) Visits(12 Months post randomization)
- Number of Non-Pharmacologic Pain Care Visits(6 Months and 12 Months post randomization)