Electronic Sexual Reproductive Health CDS Tool at the Children's Hospital of Philadelphia

NCT04974086 | Completed

• 2 other identifiers: 21-018609K23MH119976
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Many studies show early detection of sexual activity in adolescents can improve their health management and that primary care pediatricians would benefit from supports to address adolescent health, including sexual and reproductive health. The primary objective of this study is to develop and evaluate the feasibility, acceptability, and usability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool within the electronic health record (EHR) among clinicians, adolescent patients, and their parents. Secondary objectives include assessment of the CDS tool's impact on clinical measures. The STI Testing CDS tool will be embedded within clinical practice and evaluated through a single-armed prospective cohort study of primary care clinicians, adolescent patients, and parents. The STI Testing CDS tool that will support pediatric clinicians by providing evidence-based sexual health-related screening, treatment, and referrals, as needed.

Conditions

Sexual and Reproductive Health

Outcome Measures

Primary Outcomes (5)

• Usability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among clinicians as assessed by the SUS.

  The System Usability Scale (SUS) is a validated 10-item tool used for measuring subjective assessments of usability. This survey will be presented to pediatric clinicians using the sexual reproductive health (SRH) CDS tool and they will be asked to rate how much they agree/disagree with 10 statements related to the tool's usability.

  1 day

• Acceptability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among clinicians as assessed through qualitative interviews.

  Qualitative interviews will be conducted with pediatric clinicians who use the CDS tool. This interview will be one-on-one and ask questions that assess attitudes towards using the tool and feedback on how to improve the tool.

  1 day

• Feasibility of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among clinicians as assessed through qualitative interviews.

  Qualitative interviews will be conducted with pediatric clinicians who use the CDS tool. This interview will be one-on-one and ask questions that assess feasibility of consistently using the tool in practice and feedback on how to improve use of the tool within the adolescent encounter.

  1 day

• Acceptability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among adolescents

  This will be measured through a survey for adolescents who presented for a well child care visit and completed the Adolescent Health Questionnaire (a health screener used as standard care in all well child care visits). The survey consists of 36 potential questions about acceptability of a questionnaire part of standard well visits and of potential reproductive health services they received during their visit, attitudes towards privacy of their visit and discussions with their provider, \& feedback on discussions that occurred between them and a parent/guardian after their visit.

  1 day

• Acceptability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among parents of adolescents

  This will be measured through a survey for parents of adolescents who were present during their child's well child care visit. The survey consists of 22 potential questions about acceptability of a questionnaire that includes measuring perspectives on sexual healthcare for teens as part of standard well care, acceptability of their child receiving confidential services part of standard well care, \& feedback on discussions that occurred between them and their child after their visit.

  1 day

Secondary Outcomes (2)

• Assessment of the CDS tool's impact on the number of sexually transmitted infection/human immunodeficiency virus (STI/HIV) tests ordered.

  up to 2 years

• Assessment of the CDS tool's impact on the number of positive STI/HIV tests.

  up to 2 years

Study Arms (1)

CDS Tool Evaluation

EXPERIMENTAL

All participants will receive intervention and feasibility, acceptability, and usability of intervention will be assessed from each participant cohort group.

Other: Sexually transmitted infection (STI) testing clinical decision support (CDS) tool

Interventions

Sexually transmitted infection (STI) testing clinical decision support (CDS) tool OTHER

The intervention, called the STI Testing CDS tool, includes integrating STI testing guideline prompts into the electronic health record (EHR). The prompt guides clinicians to assess and broadly respond to adolescents' sexual health behaviors through EHR survey data. Through the CDS tool, clinicians will be prompted to provide comprehensive and evidence-based sexual health care for teens including, for example: providing patient-facing education about sexual preventative health topics and facilitating ordering of HIV and sexually transmitted infection (STI) laboratory tests to improve both risk-based and routine annual preventative screening.

CDS Tool Evaluation

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Coitus

Interventions

Compact Disks; Equipment and Supplies

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Videodisc Recording; Optical Storage Devices; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Brian P. Jenssen, MD

  Primary care pediatrician and researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm prospective cohort study

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: July 23, 2021
• Study Start: September 26, 2023
• Primary Completion: February 11, 2024
• Study Completion: February 11, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)