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

NCT ID: NCT04974086

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-26
• Study Completion Date: 2024-02-11

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.

Detailed Description

The STI Testing CDS tool will be embedded within the electronic health record (EHR) and will be evaluated to include feasibility (through medical record review for EHR utilization data), pediatric clinician acceptability and usability of the intervention (using surveys and semi-structured interviews), and adolescent and parent acceptability of the approach (using surveys). The secondary outcomes include measures of clinical impact, including ordering (and the results) of gonorrhea, chlamydia, and HIV screening labs.

Three cohorts of participants will be involved in the study: 1) Clinicians (attending physicians, nurse practitioners, and pediatric residents), 2) their English-speaking adolescent patients, and 3) their parents at included primary care sites.

The first 100 adolescent patients for whom the CDS tool is used will be approached in-person or remotely via text message or phone call after the clinical visit to complete a brief survey on the acceptability of the treatment provided at the visit, acceptability of that treatment, satisfaction with potential treatment outcomes, and if they engaged in any conversations with their parent(s) about any treatment provided at the visit.

Similarly, parents of those first 100 adolescent patients will be approached in-person or remotely via text message or phone call after the clinical visit to complete a brief survey on the acceptability of the approach to adolescent care workflow (not any specifics about the actual care provided) as well as any conversations about the visit that occurred between the parent and adolescent after the visit. Contact information, including phone number, for potential adolescent and parent participants will be retrieved from the adolescent's medical record. Additionally, Investigators will approach 50 pediatric clinicians in-person or remotely via email to complete a brief survey and semi-structured interview on the feasibility, acceptability, and usability of the CDS tool. Pediatric clinicians are eligible if they care for adolescent patients and have used the STI Testing CDS tool in practice.

Results from clinician surveys and semi-structured interviews will ensure that the CDS tool design meets clinicians' needs - ensuring a level of usability, functionality, and usefulness that supports pediatric clinicians' delivery of sexual and reproductive health care services to adolescents.

Secondary outcome measures aimed at assessing the clinical impact of the STI Testing CDS tool will include:

• Number of gonorrhea, chlamydia, and HIV tests ordered as a result of the CDS tool,
• And, the number of positive gonorrhea, chlamydia, and HIV tests ordered as a result of the CDS tool.

This study presents no more than minimal risk to study participants, as this is a study aimed to assess the creation of a tool that helps to improve upon the current delivery of sexual and reproductive health services provided through pediatric primary care.

Conditions

Sexual and Reproductive Health

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

CDS Tool Evaluation

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

• Adolescent patients who meet the following inclusion criteria will be eligible: Sexually transmitted infection (STI) testing clinical decision support (CDS) tool is used at the preventive care visit, age 13 years or older, English-speaking
• Parents who meet the following inclusion criteria will be eligible: Attend a preventive care visit with their adolescent child, are 18 years of age or older, English-speaking, have a smartphone, personal contact information is available in their child's electronic health record (EHR)
• Clinicians who meet the following inclusion criteria will be eligible: Use the STI Testing CDS tool at a preventative care visit with an adolescent patient

Exclusion Criteria:

• Subjects who do not meet the above inclusion criteria will be excluded.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian P. Jenssen, MD

Role: PRINCIPAL_INVESTIGATOR

Primary care pediatrician and researcher

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

K23MH119976

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-018609

Identifier Type: -

Identifier Source: org_study_id