Dizziness
Conditions
Keywords
dizziness, Physical therapy, FEED-PT, Feasibility, Emergency Department
Brief summary
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.
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
OTHERUsual Care
Standard-of-care treatment for dizziness presenting in the emergency department
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.
Sponsors
Northwestern University
University of Utah
Northwestern Lake Forest Hospital
Northwestern Memorial Hospital
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * English or Spanish-speaking
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal participant surveys (effectiveness): missing data rate for the Dizziness Handicap Inventory | 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 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. |
| Electronic Health Record (EHR) extraction (implementation): fidelity of Emergency Department (ED) physical therapy | Baseline | Fidelity is defined as the number of dizziness 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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. |
| 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 prescribing sedating medications (including antihistamines and benzodiazepines) | 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. |
Countries
United States
Contacts
CONTACTHoward Kim, MD, MS
Outcome results
None listed