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

NCT07224945 | Recruiting DMC

• 2 other identifiers: FEED-PTR01AT012367
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Keywords

Low back pain; Physical therapy; FEED-PT; Feasibility; Emergency department

Outcome Measures

Primary Outcomes (6)

• Longitudinal participant surveys (effectiveness): missing data rate for the Patient-Reported Outcome Measurement Information System (PROMIS)-Pain Interference (PI) assessment.

  Rate of missing data for assessments administered between baseline and 12 months. Variable type: binary / proportion.

  12 months

• Longitudinal participant surveys (effectiveness): screening-to-enrollment ratio

  Number of participants who enter screening compared to the number of participants who enroll in the study. Variable type: binary / proportion.

  Baseline

• Longitudinal participant surveys (effectiveness): participant retention rate defined as completion of at least one follow-up survey.

  Ratio of participants enrolled to the number who complete at least one follow-up survey.

  12 months.

• Electronic Health Record (EHR) extraction (implementation): adoption of Emergency Department (ED) physical therapy

  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.

  Baseline

• Electronic Health Record (EHR) extraction (implementation): fidelity of Emergency Department (ED) physical therapy

  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.

  Baseline

• 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. Variable type: continuous.

  1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.

Secondary Outcomes (7)

• 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.

Other Outcomes (1)

• Participant and clinician focus groups (implementation)

  1-6 months before the first participant enrolls and 1-6 months after the study closes to follow-up.

Study Arms (2)

Embedded Emergency Department Physical Therapy

EXPERIMENTAL

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.

Other: Embedded Emergency Department Physical Therapy

Usual Care

OTHER

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.

Other: Usual Care

Interventions

Usual Care OTHER

Standard-of-care treatment for low back pain presenting in the emergency department

Usual Care

Embedded Emergency Department Physical Therapy OTHER

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.

Embedded Emergency Department Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern Memorial Hospital: collaborator
• Northwestern University: lead
• University of Utah: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Northwestern Lake Forest Hospital: collaborator

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Emergencies

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Central Study Contacts

Howard Kim, MD, MS

CONTACT

312-926-0591; howard.kim@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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 electronic health record data to assist in feasibility assessments for a future full-scale trial.

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: November 5, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 4, 2028
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Scientific data will be made available at the end of the award period or at the time of the corresponding publication, in the case of any publications that pre-date the award end date. Datasets resulting from this work will remain available in the repository in perpetuity or until deaccessioned at the discretion of the repository.
• Access Criteria: Access to scientific data and metadata will not be controlled after archiving. Arch is an open access repository that is focused on digital data archiving and unmediated public access to research results.

Locations

US (2)