Pilot Study of an Innovative Model to Provide Evidence-Based Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Number of ED patients eligible for recruitment as measured by patient log
研究概览
简要总结
The purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) in the ED in a pilot study of ED patients with neck or back pain. We will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. Primary outcomes will focus on feasibility based on recruitment and retention rates, and acceptability based on a 5-point patient satisfaction scale, while secondary outcomes will include pain severity, pain interference, anxiety, physical function, opioid use, repeat ED visits, and hospitalizations at 1 hour and at 24 hours, 1 month and 3 months after ED discharge.
We will use pilot study results to develop a protocol for a larger pragmatic randomized clinical trial designed to rigorously evaluate PIPT in the ED combined with Spine Health follow up for ED patients with neck or back pain. We will perform a process evaluation of our proposed clinical trial study design, including characterizing and quantifying the degree of CBT and PT components used by treating PTs while in the ED and during Spine Health follow up, number of Spine Health visits attended in the first month, and integration into usual ED care. Qualitative interviews will be used to identify facilitators, barriers and potential solutions to intervention and research study procedures based on the patients' experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, 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
- 是
入选标准
- •Adults (age 18 years or older),
- •Presented to the ED with pain in the neck and/or back,
- •A diagnosis of musculoskeletal pain as determined by an ED provider,
- •Able to read and understand the consent form in English.
排除标准
- •Suspected to have a non-musculoskeletal cause of pain;
- •Unable to provide informed consent or to comprehend or complete study measures or procedures due to cognitive impairment, including evidence of drug, medication or alcohol intoxication, or due to severe hearing or speech impairment;
- •Unable to safely participate due to critical illness, emergent surgical need, other serious medical condition (including active COVID-19 infection),
- •ED provider judgment.
研究组 & 干预措施
Psychologically-Informed Physical Therapy (PIPT)
CBT-trained physical therapist evaluation and treatment with recommendation for Spine Health follow up after ED discharge
干预措施: Psychologically-Informed Physical Therapy (PIPT) (Behavioral)
Control
Usual care only
结局指标
主要结局
Number of ED patients eligible for recruitment as measured by patient log
时间窗: Post implementation, up to 6 weeks
Number of patients retained in study as measured by patient log
时间窗: Post implementation, up to 6 weeks
Number of patients enrolled as measured by patient log
时间窗: Post implementation, up to 6 weeks
Number of patients that found treatment satisfactory via satisfactory questionnaire
时间窗: Post implementation, up to 6 weeks
5 point Likert-scale satisfaction scale
次要结局
- Change in pain related distress(ED pre-treatment (baseline); 1 and 3 months post discharge)
- Change in Anxiety Level(ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge)
- Change in Function(ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge)
- Number of repeat ED visits(up to 3 months post discharge)
- Change in Pain Score(ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge)
- Change in self efficacy(ED pre-treatment (baseline); 1 and 3 months post discharge)
- Number of pain medications prescribed(up to 3 months post discharge)
- Number of Spine Health visits for follow up PT(up to 3 months post discharge)
- Change in Quality of Life (QoL)(ED pre-treatment (baseline); ED post-treatment (1 hour); 24 hours post discharge)
- Change in severity of chronic pain(ED pre-treatment (baseline); 1 and 3 months post discharge)
- Number of Spine Health referrals for follow up PT(At ED discharge (up to 48 hours))
- Number of patient hospitalizations(up to 3 months post discharge)