A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy (FEED-PT)

Northwestern University

Status: Enrolling

Conditions: Low Back Pain

Treatments: Other: Usual Care; Other: Embedded Emergency Department Physical Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07224945

FEED-PT

R01AT012367 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Embedded Emergency Department Physical Therapy

Experimental group

Description:

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.

Treatment:

Other: Embedded Emergency Department Physical Therapy

Usual Care

Other group

Description:

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.

Treatment:

Other: Usual Care