NCT06531421

Brief Summary

This trial will assess whether development and sharing of 'Equity Report Cards' focussed on the recognition and treatment of pain for injured children by Emergency Medical Services (EMS) can help decrease disparities by race and ethnicity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

July 29, 2024

Last Update Submit

December 17, 2024

Conditions

Keywords

Racial Groups

Outcome Measures

Primary Outcomes (1)

  • Reduction in pain

    Proportion of children who have a reduction in pain score

    1 year

Secondary Outcomes (3)

  • Pain score documented

    1 year

  • Any analgesia administered

    1 year

  • Opiate analgesia administered

    1 year

Study Arms (1)

Intervention

OTHER

Distribution of Equity Report Cards

Other: Equity Report Cards

Interventions

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.

Intervention

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20002, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Caleb E Ward, MD, MPH

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caleb E Ward, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This is a pragmatic single-arm trial using an interrupted time-series design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 1, 2024

Study Start

January 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations