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

Overview

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.

Interventions

• Other 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.
• Other Usual Care
  Standard-of-care treatment for low back pain presenting in the emergency department

Primary outcome measures

• Longitudinal participant surveys (effectiveness): missing data rate for the Patient-Reported Outcome Measurement Information System (PROMIS)-Pain Interference (PI) assessment. [Time frame: 12 months]
• Longitudinal participant surveys (effectiveness): screening-to-enrollment ratio [Time frame: Baseline]
• Longitudinal participant surveys (effectiveness): participant retention rate defined as completion of at least one follow-up survey. [Time frame: 12 months.]
• Electronic Health Record (EHR) extraction (implementation): adoption of Emergency Department (ED) physical therapy [Time frame: Baseline]
• Electronic Health Record (EHR) extraction (implementation): fidelity of Emergency Department (ED) physical therapy [Time frame: Baseline]
• Clinician surveys before and after implementation of the intervention (implementation): Normalisation Measure Development Questionnaire (NoMAD) questionnaire scores [Time frame: 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.]

Secondary outcome measures (7)

• Longitudinal participant surveys (effectiveness): a sum of the missing data rate for the remaining Participant Reported Outcomes (PROs) combined. [Time frame: 12 months]
• Electronic Health Record (EHR) extraction (effectiveness): rate of subsequent health care encounters. [Time frame: 12 months]
• Electronic Health Record (EHR) extraction (effectiveness): rate of opioid prescribing [Time frame: 12 months]
• Electronic Health Record (EHR) extraction (effectiveness): rate of advanced diagnostic imaging [Time frame: 12 months]
• Clinician surveys before and after implementation of the intervention (implementation): Acceptability of Intervention Measure (AIM) [Time frame: 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) [Time frame: 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). [Time frame: 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Northwestern Memorial Hospital — Chicago
• University of Utah — Salt Lake City

Identifiers

NCT: NCT07224945 · FEED-PT · R01AT012367

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗