Sexual and Reproductive HealthNCT04974086
Electronic Sexual Reproductive Health CDS Tool at the Children's Hospital of Philadelphia
A study testing Sexually transmitted infection (STI) testing clinical decision support (CDS) tool in people with Sexual and Reproductive Health, run by Children's Hospital of Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual and Reproductive Health
- What is being tested?
- Sexually transmitted infection (STI) testing clinical decision support (CDS) tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2023to 11 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects who do not meet the above inclusion criteria will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
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.
Read the 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
- Being tested
- Sexually transmitted infection (STI) testing clinical decision support (CDS) tool
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexually transmitted infection (STI) testing clinical decision support (CDS) toolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CDS Tool Evaluation | Experimental | All participants will receive intervention and feasibility, acceptability, and usability of intervention will be assessed from each participant cohort group. Receives: Other: Sexually transmitted infection (STI) testing clinical decision support (CDS) tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
This will be measured by the difference in pre- and post-intervention metrics for the number of gonorrhea, chlamydia, and HIV tests ordered as a result of the CDS tool. These metrics will be measured by pre- and post-intervention data analytics provided by the Children's Hospital of Philadelphia (CHOP) Department of Biomedical and Health Informatics (DBHI).
Measured: up to 2 years
Assessment of the CDS tool's impact on the number of positive STI/HIV tests.
This will be measured by the difference in pre- and post-intervention metrics for the number of positive STI/HIV tests as a result of the CDS tool. These metrics will be measured by pre- and post-intervention data analytics provided by the Children's Hospital of Philadelphia (CHOP) Department of Biomedical and Health Informatics (DBHI).
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start26 Sep 2023
- Primary completion11 Feb 2024
- Study completion11 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual and Reproductive HealthStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm prospective cohort study
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Brian P. Jenssen, MD, Principal investigator, Primary care pediatrician and researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974086
- Sponsor's protocol ID
- 21-018609
- Other IDs
- K23MH119976
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2021
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Electronic Clinical Decision Support Tool for Adolescent Sexual and Reproductive Health Services
- ClinicalTrials.gov ID
- NCT04974086
- Acronym / sponsor ID
- 21-018609
- Conditions
- Sexual and Reproductive Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 11 Feb 2024 (actual)
- Study completion
- 11 Feb 2024 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| CDS Tool Evaluation | Experimental | Other: Sexually transmitted infection (STI) testing clinical decision support (CDS) toolAll participants will receive intervention and feasibility, acceptability, and usability of intervention will be assessed from each participant cohort group. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects who do not meet the above inclusion criteria will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexually transmitted infection (STI) testing clinical decision support (CDS) toolThe 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. | Other | CDS Tool Evaluation |
Primary outcome
Usability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among clinicians as assessed by the SUS.
Time frame: 1 day
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.
Acceptability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among clinicians as assessed through qualitative interviews.
Time frame: 1 day
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.
Feasibility of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among clinicians as assessed through qualitative interviews.
Time frame: 1 day
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.
Acceptability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among adolescents
Time frame: 1 day
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.
Acceptability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among parents of adolescents
Time frame: 1 day
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.
2 secondary outcomes
Assessment of the CDS tool's impact on the number of sexually transmitted infection/human immunodeficiency virus (STI/HIV) tests ordered.
Time frame: up to 2 years
Assessment of the CDS tool's impact on the number of positive STI/HIV tests.
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian P. Jenssen, MD principal investigator
Primary care pediatrician and researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexually transmitted infection (STI) testing clinical decision support (CDS) tool in people with Sexual and Reproductive Health, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool among clinicians as assessed by the SUS. (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.