Clinical trial NCT04974086: Electronic Sexual Reproductive Health CDS Tool at the Children's Hospital of Philadelphia
Official title: Feasibility and Acceptability of an Electronic Clinical Decision Support Tool for Adolescent Sexual and Reproductive Health Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual and Reproductive Health
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-07-23
Enrollment: 190
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm prospective cohort study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Usability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among clinicians as assessed by the SUS.
timeFrame: 1 day
measure: Acceptability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among clinicians as assessed through qualitative interviews.
timeFrame: 1 day
measure: Feasibility of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among clinicians as assessed through qualitative interviews.
timeFrame: 1 day
measure: Acceptability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among adolescents
timeFrame: 1 day
measure: Acceptability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among parents of adolescents
timeFrame: 1 day
Secondary outcomes:
measure: Assessment of the CDS tool's impact on the number of sexually transmitted infection/human immunodeficiency virus (STI/HIV) tests ordered.
timeFrame: up to 2 years
measure: Assessment of the CDS tool's impact on the number of positive STI/HIV tests.
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Primary care pediatrician and researcher
name: Brian P. Jenssen, MD
role: PRINCIPAL_INVESTIGATOR
References: