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PAINED: Project Addressing INequities in the Emergency Department (PAINED)

Primary Purpose

Pain, Appendicitis, Bias, Racial

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Department-level audit and feedback and electronic health record-embedded clinical decision support
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All Children's National Hospital Emergency Department clinicians

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

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

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    Analgesia use
    Rate of analgesia use

    Secondary Outcome Measures

    Full Information

    First Posted
    July 15, 2022
    Last Updated
    August 3, 2022
    Sponsor
    Children's National Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05488080
    Brief Title
    PAINED: Project Addressing INequities in the Emergency Department
    Acronym
    PAINED
    Official Title
    PAINED: Project Addressing INequities in the Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2024 (Anticipated)
    Primary Completion Date
    July 31, 2027 (Anticipated)
    Study Completion Date
    July 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Children's National Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Appendicitis, Bias, Racial, Fractures, Bone

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    The study design is a pragmatic clinical trial.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Department-level audit and feedback and electronic health record-embedded clinical decision support
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Department-level audit and feedback and electronic health record-embedded clinical decision support
    Intervention Description
    This intervention will provide clinicians with Equity Report Cards and clinician decision support on mitigating disparities in quality of care.
    Primary Outcome Measure Information:
    Title
    Pain reduction
    Description
    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
    Title
    Analgesia use
    Description
    Rate of analgesia use
    Time Frame
    Equity Report Cards provided monthly to clinicians over a 24-month period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All Children's National Hospital Emergency Department clinicians Exclusion Criteria: None
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Monika Lemke, MSN, MPH
    Phone
    202-476-6005
    Email
    mlemke2@childrensnational.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    PAINED: Project Addressing INequities in the Emergency Department

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