A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy

Not Applicable

Not yet recruiting

• Conditions: Low Back Pain

• Registration Number: NCT07224945
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-10-10
• Status Verified: 2025-11
• Study First Submitted QC: 2025-11-03
• Last Update Submitted: 2025-11-03
• Study First Posted: 2025-11-05
• Last Update Posted: 2025-11-05
• Study Start: 2025-12-01
• Primary Completion: 2026-11-30
• Study Completion: 2027-09-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• 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

Exclusion Criteria

• "Red flag" symptoms indicating a life or limb-threatening process
• Currently in police custody
• Unable to consent
• Known pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Longitudinal participant surveys (effectiveness): missing data rate for the Patient-Reported Outcome Measurement Information System (PROMIS)-Pain Interference (PI) assessment.	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	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.	12 months.	Ratio of participants enrolled to the number who complete at least one follow-up survey.
Electronic Health Record (EHR) extraction (implementation): adoption of Emergency Department (ED) physical therapy	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Longitudinal participant surveys (effectiveness): a sum of the missing data rate for the remaining Participant Reported Outcomes (PROs) combined.	12 months	Missing data rate for each PRO will not be analyzed separately, but will be combined into one measurement as one outcome. PROs: modified Oswestry Disability Index (ODI), four-item Pain Catastrophizing Score, four item Pain Self-Efficacy Questionnaire, Global Rating of Change, Numeric Pain Rating Scale, additional healthcare utilization (e.g., physical therapy, ED, doctor's office), and a medication use survey.
Electronic Health Record (EHR) extraction (effectiveness): rate of subsequent health care encounters.	12 months	Variable type: count, may be considered binary / proportion
Electronic Health Record (EHR) extraction (effectiveness): rate of opioid prescribing	12 months	Variable type: count, may be considered binary / proportion
Electronic Health Record (EHR) extraction (effectiveness): rate of advanced diagnostic imaging	12 months	Variable type: count, may be considered binary / proportion
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.	1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome.
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.	1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome.
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.	1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome.

Trial Locations

Locations (2)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States