- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05488080
PAINED: Project Addressing INequities in the Emergency Department (PAINED)
December 11, 2023 updated by: Monika Goyal, Children's National Research Institute
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Monika Goyal, MD
- Phone Number: 2024762869
- Email: mgoyal@cnmc.org
Study Contact Backup
- Name: Meleah Boyle
- Phone Number: 2024765388
- Email: mdboyle@childrensnational.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- All Children's National Hospital Emergency Department clinicians
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
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.
|
This intervention will provide clinicians with Equity Report Cards and clinician decision support on mitigating disparities in quality of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain reduction
Time Frame: Equity Report Cards provided monthly to clinicians over a 24-month period
|
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
Time Frame: Equity Report Cards provided monthly to clinicians over a 24-month period
|
Rate of analgesia use
|
Equity Report Cards provided monthly to clinicians over a 24-month period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2024
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
July 15, 2022
First Submitted That Met QC Criteria
August 3, 2022
First Posted (Actual)
August 4, 2022
Study Record Updates
Last Update Posted (Actual)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 11, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP00005944 / 1R61DK135406 - 01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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