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Health Information Technology to Reduce Disparities in Adolescent Health Outcomes: A Pragmatic Trial

Primary Purpose

Sexually Transmitted Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SHS-derived CDS
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sexually Transmitted Diseases

Eligibility Criteria

15 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adolescents aged 15-21 years seeking care in the emergency department

Exclusion Criteria:

  • Patients will be excluded if unable to understand English, are critically ill, cognitively impaired, or otherwise unable to provide consent for completion of the sexual health survey (SHS) and STI screening.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SHS-derived CDS

    Usual care

    Arm Description

    All adolescents seen in the emergency department that meet eligibility criteria will be offered the sexual health survey (SHS) during the pragmatic trial.

    All adolescents seen in the emergency department that meet eligibility criteria prior to implementation of SHS-derived CDS.

    Outcomes

    Primary Outcome Measures

    Chlamydia trachomatis (CT) / Neisseria gonorrhoeae (GC) detection rates
    Proportion of encounters during which patients test positive for CT/GC; measured by urine-based nucleic acid amplification tests.

    Secondary Outcome Measures

    STI rates by race/ethnicity
    Change in STI rates by race/ethnicity

    Full Information

    First Posted
    April 30, 2020
    Last Updated
    February 23, 2023
    Sponsor
    Children's National Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04372875
    Brief Title
    Health Information Technology to Reduce Disparities in Adolescent Health Outcomes: A Pragmatic Trial
    Official Title
    Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    June 2027 (Anticipated)
    Study Completion Date
    June 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
    We will compare differences in sexually transmitted infection (STI) detection rates between sexual health survey (SHS)-derived electronic clinical decision support (CDS) versus usual care (e.g. no provision of CDS) using an interrupted time series design. We hypothesize that population-based STI detection rates will be higher when SHS-derived electronic CDS is provided compared to usual care. Secondary analysis will include a comparison of STI detection rates by sexual risk strata (high risk vs. at risk) and race/ethnicity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sexually Transmitted Diseases

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    37500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SHS-derived CDS
    Arm Type
    Experimental
    Arm Description
    All adolescents seen in the emergency department that meet eligibility criteria will be offered the sexual health survey (SHS) during the pragmatic trial.
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    All adolescents seen in the emergency department that meet eligibility criteria prior to implementation of SHS-derived CDS.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SHS-derived CDS
    Intervention Description
    This intervention will provide electronic clinical decision support for adolescents who screen at risk or at high risk of an STI.
    Primary Outcome Measure Information:
    Title
    Chlamydia trachomatis (CT) / Neisseria gonorrhoeae (GC) detection rates
    Description
    Proportion of encounters during which patients test positive for CT/GC; measured by urine-based nucleic acid amplification tests.
    Time Frame
    3-7 days after emergency department (ED) visit
    Secondary Outcome Measure Information:
    Title
    STI rates by race/ethnicity
    Description
    Change in STI rates by race/ethnicity
    Time Frame
    3-7 days after ED visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adolescents aged 15-21 years seeking care in the emergency department Exclusion Criteria: Patients will be excluded if unable to understand English, are critically ill, cognitively impaired, or otherwise unable to provide consent for completion of the sexual health survey (SHS) and STI screening.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Monika Lemke, MPH
    Phone
    202-476-5388
    Email
    mlemke2@cnmc.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Monika Goyal, MD
    Phone
    12024762869
    Email
    mgoyal@cnmc.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Health Information Technology to Reduce Disparities in Adolescent Health Outcomes: A Pragmatic Trial

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