A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Electronic Health Record (EHR) extraction (implementation): adoption of Emergency Department (ED) physical therapy
研究概览
简要总结
This is a multi-site feasibility trial of an embedded emergency department (ED) physical therapy care model for low back pain at two EDs in the Northwestern Medicine and University of Utah Health systems. The study intervention (embedded ED physical therapy) is a reconceptualization of the traditional outpatient physical therapy care model in which we place a physical therapist directly in the ED to initiate timely care for patients with low back pain; we previously evaluated this intervention in a single center randomized trial. This multi-site feasibility trial will be comprised of 9 months of active intervention and 12 months of longitudinal data collection. The two sites will be parallel randomized 1:1 to receive either the embedded ED physical therapy condition (intervention, n=1) or usual care (control, n=1) via simple randomization. This trial focuses on feasibility outcomes - such as our ability to enroll participants, deliver the intervention with fidelity, and collect longitudinal patient-reported outcome data and electronic health record data - but a future multi-site full-scale trial will focus on the outcomes of pain-interference and opioid use.
详细描述
After a 12-month milestone-driven planning and preparation phase, we will conduct a 21-month randomized feasibility clinical trial of the embedded ED physical therapy intervention at the Northwestern Medicine and University of Utah health systems, comprised of 9 months of active intervention and 12 months of longitudinal data collection. Two hospital EDs (Northwestern Memorial Hospital, University of Utah Hospital) will be randomized to receive either the embedded ED physical therapist intervention (treatment, n=1) or usual care (control, n=1). Following completion of the feasibility trial, the control site will receive the intervention as per standard waitlist procedures for randomized trials. A third hospital ED (Northwestern Lake Forest Hospital) will not participate in randomization or participant enrollment but will contribute baseline electronic health record data to assist in feasibility assessments for a future full-scale trial.
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
- •Emergency Department (ED) visit with primary diagnosis related to low back pain
- •ED visit occurring at an ED site participating in randomization (Northwestern Memorial Hospital, University of Utah Hospital)
- •ED visit check-in time during the hours of 8am-8pm
- •Current episode of low back pain less than or equal to 30 days, defined as pain between the 12th rib and buttocks
- •Age greater than or equal to 18 years; there is no age maximum
- •English or Spanish-speaking
排除标准
- •"Red flag" symptoms indicating a life or limb-threatening process
- •Currently in police custody
- •Unable to consent
- •Known pregnancy
研究组 & 干预措施
Embedded Emergency Department Physical Therapy
We place a physical therapist directly in the emergency department to initiate timely care for patients with low back pain rather than waiting on an outpatient referral to physical therapy, which can often take weeks to accomplish, if ever at all. The actual techniques and approaches used by the embedded ED physical therapist in this study (e.g., exercises, maneuvers, coaching) are standard-of-care and do not involve investigational interventions, devices, or drugs.
干预措施: Embedded Emergency Department Physical Therapy (Other)
Usual Care
Usual care treatment for low back pain presenting in the emergency department (ED). Usual care consists of any ED testing or treatment not involving an ED physical therapist in accordance with the treating physician's usual and customary practice. This could include diagnostic imaging, patient education and resources, and administration and/or prescribing of analgesic medications.
干预措施: Usual Care (Other)
结局指标
主要结局
Electronic Health Record (EHR) extraction (implementation): adoption of Emergency Department (ED) physical therapy
时间窗: Baseline
Adoption is defined as the number of potentially eligible low back pain ED visits have a documented order for a physical therapy evaluation. Cross-sectional at the level of site/Emergency Department during the trial. Variable type: Proportion.
Electronic Health Record (EHR) extraction (implementation): fidelity of Emergency Department (ED) physical therapy
时间窗: Baseline
Fidelity is defined as the number of low back pain ED visits that have a structured research note documenting use of the protocol. Cross-sectional at the level of site/Emergency Department (ED) during the trial. Variable type: proportion.
Clinician surveys before and after implementation of the intervention (implementation): Normalisation Measure Development Questionnaire (NoMAD) questionnaire scores
时间窗: 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous.
Longitudinal participant surveys (effectiveness): missing data rate for the Patient-Reported Outcome Measurement Information System (PROMIS)-Pain Interference (PI) assessment.
时间窗: 12 months
Rate of missing data for assessments administered between baseline and 12 months. Variable type: binary / proportion.
Longitudinal participant surveys (effectiveness): screening-to-enrollment ratio
时间窗: Baseline
Number of participants who enter screening compared to the number of participants who enroll in the study. Variable type: binary / proportion.
Longitudinal participant surveys (effectiveness): participant retention rate defined as completion of at least one follow-up survey.
时间窗: 12 months.
Ratio of participants enrolled to the number who complete at least one follow-up survey.
次要结局
- Longitudinal participant surveys (effectiveness): a sum of the missing data rate for the remaining Participant Reported Outcomes (PROs) combined.(12 months)
- Electronic Health Record (EHR) extraction (effectiveness): rate of subsequent health care encounters.(12 months)
- Electronic Health Record (EHR) extraction (effectiveness): rate of opioid prescribing(12 months)
- Electronic Health Record (EHR) extraction (effectiveness): rate of advanced diagnostic imaging(12 months)
- Clinician surveys before and after implementation of the intervention (implementation): Acceptability of Intervention Measure (AIM)(1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.)
- Clinician surveys before and after implementation of the intervention (implementation): Intervention Appropriateness Measure (IAM)(1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.)
- Clinician surveys before and after implementation of the intervention (implementation): Feasibility of Intervention measure (FIM).(1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.)
研究者
Howard Kim
Associate Professor
Northwestern University