Clincosm LogoSign in Get a demo

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

Sponsor
Children's National Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04372875
Collaborator
(none)
37,500
Enrollment
2
Arms
59
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SHS-derived CDS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
37500 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2027
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHS-derived CDS

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

Behavioral: SHS-derived CDS
This intervention will provide electronic clinical decision support for adolescents who screen at risk or at high risk of an STI.
No Intervention: Usual care

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

Outcome Measures

Primary Outcome Measures

  1. Chlamydia trachomatis (CT) / Neisseria gonorrhoeae (GC) detection rates [3-7 days after emergency department (ED) visit]

    Proportion of encounters during which patients test positive for CT/GC; measured by urine-based nucleic acid amplification tests.

Secondary Outcome Measures

  1. STI rates by race/ethnicity [3-7 days after ED visit]

    Change in STI rates by race/ethnicity

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Children's National Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Monika Goyal, Associate Professor of Pediatrics and Emergency Medicine, Children's National Research Institute
ClinicalTrials.gov Identifier:
NCT04372875
Other Study ID Numbers:
  • Pro00014276
First Posted:
May 4, 2020
Last Update Posted:
Oct 4, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sexually Transmitted Diseases

Study Results

No Results Posted as of Oct 4, 2021