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

ConditionDizziness

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNorthwestern University

About this trial

This is a multi-site feasibility trial of an embedded emergency department (ED) physical therapy care model for dizziness 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 dizziness; we previously evaluated this intervention in a single center randomized trial for low back pain. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Emergency Department (ED) visit with primary diagnosis related to dizziness

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

Age greater than or equal to 18 years; there is no age maximum

Disqualifiers

Severe neurologic deficit concerning for ischemic or hemorrhagic stroke (i.e., that would necessitate activating a stroke code)

Currently in police custody

Unable to consent

Known pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

Embedded Emergency Department Physical Therapy
Other intervention
We place a physical therapist directly in the emergency department to initiate timely care for patients with dizziness 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.
Usual Care
Other intervention
Standard-of-care treatment for dizziness presenting in the emergency department

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Embedded Emergency Department Physical TherapyExperimental treatment 1 intervention

Group B: Usual CareOther 1 intervention

Trial outcomes

Primary outcomes

Longitudinal participant surveys (effectiveness): missing data rate for the Dizziness Handicap Inventory

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

Time frame

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.

Time frame

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.

Time frame

12 months

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

Adoption is defined as the number of potentially eligible dizziness 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.

Time frame

Baseline

Secondary outcomes

Longitudinal participant surveys (effectiveness): a sum of the missing data rate for the remaining Participant Reported Outcomes (PROs) combined.

Missing data rate for each PRO will not be analyzed separately, but will be combined into one measurement as one outcome. PROs: nine-item Vestibular Activities Avoidance Instrument (VAAI), Global Rating of Change, Numeric Pain Rating Scale, additional healthcare utilization (e.g., physical therapy, ED, doctor's office), and a medication use survey.

Time frame

12 months

Electronic Health Record (EHR) extraction (effectiveness): rate of subsequent health care encounters.

Variable type: count, may be considered binary / proportion

Time frame

12 months

Electronic Health Record (EHR) extraction (effectiveness): rate of prescribing sedating medications (including antihistamines and benzodiazepines)

Variable type: count, may be considered binary / proportion

Time frame

12 months

Electronic Health Record (EHR) extraction (effectiveness): rate of advanced diagnostic imaging

Variable type: count, may be considered binary / proportion

Time frame

12 months

Other outcomes

Participant and clinician focus groups (implementation)

These data will be collected and analyzed qualitatively.

Time frame

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

Sponsors and contacts

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Northwestern University

Lead sponsor

University of Utah

Collaborator

Northwestern Lake Forest Hospital

Collaborator

Northwestern Memorial Hospital

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov

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