Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04974086 |
| Other study ID # |
21-018609 |
| Secondary ID |
K23MH119976 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 26, 2023 |
| Est. completion date |
February 11, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Children's Hospital of Philadelphia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
