NCT05488080

Brief Summary

Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. The objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
22,032

participants targeted

Target at P75+ for not_applicable pain

Timeline
3mo left

Started Feb 2023

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
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

Study Progress92%
Feb 2023Aug 2026

First Submitted

Initial submission to the registry

July 15, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

February 27, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2026

Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

3.5 years

First QC Date

July 15, 2022

Last Update Submit

July 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain reduction

    Percentage of patients with pain reduction, pain is measured on a 0 to 10 scale, 0 is the minimum and 10 is the maximum, a lower score is a better outcome.

    Equity Report Cards provided monthly to clinicians over a 24-month period

  • Analgesia use

    Rate of analgesia use

    Equity Report Cards provided monthly to clinicians over a 24-month period

Study Arms (1)

Department-level audit and feedback and electronic health record-embedded clinical decision support

EXPERIMENTAL

Clinicians will receive monthly pooled, department-level 'Equity Report Cards' that will provide aggregate information on clinical data stratified by patient race/ethnicity. Subsequently, for all visits that may be related to appendicitis or long bone fracture, clinicians will then receive real-time, electronic health record-embedded clinical decision support regarding pain management.

Behavioral: Department-level audit and feedback and electronic health record-embedded clinical decision support

Interventions

This intervention will provide clinicians with Equity Report Cards and clinician decision support on mitigating disparities in quality of care.

Department-level audit and feedback and electronic health record-embedded clinical decision support

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All Children's National Hospital Emergency Department clinicians
  • Patients 0-21 years with symptoms suggestive of appendicitis or long bone fracture

You may not qualify if:

  • Emergency Severity Index (ESI 1)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20016-1838, United States

RECRUITING

MeSH Terms

Conditions

PainAppendicitisRacismFractures, Bone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsIntraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPrejudiceSocial BehaviorBehaviorSocial DiscriminationWounds and Injuries

Study Officials

  • Monika Goyal

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The study design is a pragmatic clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics and Emergency Medicine

Study Record Dates

First Submitted

July 15, 2022

First Posted

August 4, 2022

Study Start

February 27, 2023

Primary Completion (Estimated)

August 23, 2026

Study Completion (Estimated)

August 23, 2026

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations