Integrative Health Coaching for Back Pain: An Emergency Department-to-Home Recovery Model
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Feasibility - study enrollment
研究概览
简要总结
The goal of this two-group randomized trial is to determine the feasibility and acceptability of a remotely-delivered health coaching intervention offered in conjunction with usual care for patients with an acute exacerbation of chronic low back pain who present to the emergency department (ED).
The main questions this feasibility trial aims to answer are:
- Is our health coaching intervention and randomized trial methodology feasible to conduct?
- Is our health coaching intervention acceptable to participants and ED providers?
Participants will be randomized to one of two groups (usual ED care plus health coaching or usual ED care plus education) and complete outcome assessments at 3 and 6 months after ED discharge. Participants and ED providers will also complete an interview.
详细描述
This study is a two-group randomized feasibility trial of usual ED care plus either remote health coaching or remote education in patients with acute exacerbation of chronic low back pain presenting to the ED. We hypothesize that our health coaching intervention and randomized trial methodology will be feasible and that our health coaching intervention will be acceptable to participants and ED providers.
Forty participants will be randomized (20 per group), with 36 (90%) retained in the trial up to 6 months follow-up. Eligible patients presenting to the ED with a chief complaint of acute exacerbation of chronic low back pain will be randomized. Patients will be enrolled during or shortly after their ED visit, asked to complete a baseline questionnaire, and then randomized. Randomized participants will receive 8 calls from either a health coach or education provider, and be asked to complete assessments at 3 and 6 months after ED discharge. Interviews will be conducted with randomized participants and 15 ED providers asking about their experience with the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Chief complaint of musculoskeletal LBP
- •Meets NIH-supported chronic LBP criterion (e.g., pain greater than 3 months that has resulted in pain on at least half the days in the past 6 months)
- •Age 18 years of age or older
- •English-speaking
排除标准
- •Requires hospitalization for an acute medical condition or active comorbidity
- •In the opinion of the investigator has a severe psychiatric or behavioral diagnosis or substance use disorder that would interfere with the ability to perform the intervention and complete follow-up
- •Involved in litigation related to the LBP condition
研究组 & 干预措施
Usual ED Care plus Health Coaching
干预措施: Usual ED Care plus Health Coaching (Behavioral)
Usual ED Care plus Education
干预措施: Usual ED Care plus Education (Behavioral)
结局指标
主要结局
Feasibility - study enrollment
时间窗: Baseline
Percentage of eligible patients enrolled into study
Acceptability - Intervention Appropriateness Measure (IAM)
时间窗: 3 months after ED discharge
4-item questionnaire assessing appropriateness of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater appropriateness.
Perceptions of intervention
时间窗: 3 months after ED discharge
Perceptions of intervention as assessed through an interview
Feasibility - study retention
时间窗: 3 and 6 months after ED discharge
Percentage of enrolled participants who complete assessments
Feasibility - session attendance
时间窗: 3 months after ED discharge
Median and range of sessions attended
Feasibility - Feasibility of Intervention Measure (FIM)
时间窗: 3 months after ED discharge
4-item questionnaire assessing feasibility of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater feasibility.
Acceptability - Acceptability of Intervention Measure (AIM)
时间窗: 3 months after ED discharge
4-item questionnaire assessing acceptability of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater acceptability.
次要结局
- Disability - Oswestry Disability Index(Baseline, 3 months after ED discharge, 6 months after ED discharge)
- Pain Interference - Patient-Reported Outcomes Measurement Information System(Baseline, 3 months after ED discharge, 6 months after ED discharge)
- Pain Intensity - Patient-Reported Outcomes Measurement Information System(Baseline, 3 months after ED discharge, 6 months after ED discharge)
- Physical Function - Patient-Reported Outcomes Measurement Information System (PROMIS)(Baseline, 3 months after ED discharge, 6 months after ED discharge)
研究者
Rogelio Coronado
Research Associate Professor
Vanderbilt University Medical Center