Sexual and Reproductive Health Clinical Trial
Official title:
Feasibility and Acceptability of an Electronic Clinical Decision Support Tool for Adolescent Sexual and Reproductive Health Services
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.
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. ;
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