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Active, not recruitingNCT05488080PAINEDUpdated Oct 22, 2026

PAINED: Project Addressing INequities in the Emergency Department

An interventional study of Department-level audit and feedback and electronic health record-embedded clinical decision support in Pain, Appendicitis and Bias, Racial, sponsored by Children's National Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Children's National Research Institute · Not applicable, Interventional, and Health services research

Updated Oct 22, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
22,032
Allocation
Not applicable
Ages
0 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain
  • Appendicitis
  • Bias, Racial
  • Fractures, Bone
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 22,032 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Emergency Severity Index (ESI 1)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22,032 participants (estimated)

Study arms

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

    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

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

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. Analgesia use

    Rate of analgesia use

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 22, 2026
Primary completion
Aug 23, 2026→Aug 31, 2026 (actual)
Oct 22, 2026
Study completion
Aug 23, 2026→Aug 31, 2027
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Recruiting→Active, not recruiting
    Primary completion Aug 23, 2026→Aug 31, 2026 (now actual)
    Study completion Aug 23, 2026→Aug 31, 2027
    + 4 other changes: verification date, oversight details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05488080
Responsible party
Monika Goyal (Associate Professor of Pediatrics and Emergency Medicine, Children's National Research Institute) — Principal investigator
First posted
Aug 4, 2022
Start date
Feb 27, 2023
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Monika Goyal
principal investigator · Children's National Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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