- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06531421
Use of Equity Report Cards to Mitigate Disparities in Emergency Medical Services (EMS) Care for Injured Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a pragmatic trial using an interrupted time-series design. The investigators will collect two years of retrospective data to establish a baseline. At month 2 the investigators will distribute EMS Agency-level 'Equity Report Cards' to both agency leadership and all frontline EMS providers. This 'Equity Report Card' will contain monthly pooled, agency-level information summarizing clinical data for injured children stratified by race/ethnicity. At month 7 the investigators will also distribute Battalion-level 'Equity Report Cards' to agency leadership and all frontline EMS providers. The 'Equity Report Card' will include baseline historical data and a 3-month rolling average for each of the study outcomes. The 'Equity Report Card' will also include an action plan with evidenced based recommendations specifically targeted to improve care.
The outcomes for this study include both process measures (including documentation of pain scores, administration of any analgesia and administration of opiate analgesia) and also patient-centered clinical outcomes (reduction of pain as reported by the patient). These key study outcomes align with performance measures developed by the National EMS Quality Alliance (NEMSQA).
Patient race and ethnicity will be abstracted from the EMS medical record. The investigators will also collect data regarding potential confounding variables including patient age, sex, geographic location of encounter and other dispatch details.
The investigators will conduct an interrupted time series analysis (ITSA) to evaluate the magnitude and statistical significance of the average difference (intercept) and difference between trajectories (slopes) for our 24 month control (T0) and each of the two intervention 5 month time periods (T1 and T2). This will allow the investigators to measure the impact of each additional intervention (EMS agency-level followed by the addition of Battalion-level 'Equity Report Cards').
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caleb E Ward, MD, MPH
- Phone Number: 202-476-5000
- Email: caward@childrensnational.org
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20002
- Children's National Medical Center
-
Contact:
- Caleb E Ward, MD, MPH
- Phone Number: 202-476-5000
- Email: caward@childrensnational.org
-
Principal Investigator:
- Caleb E Ward, MD, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children less than 18 years old
- Assessed by District of Columbia Fire and Emergency Medical Services (DC FEMS)
- Injury related chief complaint, primary or secondary impression
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention
Distribution of Equity Report Cards
|
At month 2 the investigators will distribute EMS Agency-level 'Equity Report Cards' to both agency leadership and all frontline EMS providers.
This 'Equity Report Card' will contain monthly pooled, agency-level information summarizing clinical data for injured children stratified by race/ethnicity.
At month 7 the investigators will also distribute Battalion-level 'Equity Report Cards' to agency leadership and all frontline EMS providers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in pain
Time Frame: 1 year
|
Proportion of children who have a reduction in pain score
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score documented
Time Frame: 1 year
|
Proportion of children who have a pain score documented by EMS
|
1 year
|
|
Any analgesia administered
Time Frame: 1 year
|
Proportion of children who have any analgesia administered by EMS
|
1 year
|
|
Opiate analgesia administered
Time Frame: 1 year
|
Proportion of children who have opiate analgesia administered by EMS
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Caleb E Ward, MD, MPH, Children's National Research Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00001103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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