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

Sexually Transmitted Diseases Clinical Trial

Official title:

Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04372875
• Other study ID #: Pro00014276
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2023
• Est. completion date: June 2027

Study information

• Verified date: December 2023
• Source: Children's National Research Institute
• Contact: Meleah Boyle
• Phone: 2024765388
• Email: mdboyle[@]childrensnational.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37500
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-7 days after emergency department (ED) visit
Secondary	STI rates by race/ethnicity	Change in STI rates by race/ethnicity	3-7 days after ED visit