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
About this trial
This is an interventional screening trial for Sexually Transmitted Diseases
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.
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
NCT ID
NCT04372875
First Posted
April 30, 2020
Last Updated
February 23, 2023
Sponsor
Children's National Research Institute
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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