Adolescent Sexually Transmitted Infection Screening in the Emergency Department (STI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03715335|
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : December 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Gonorrhea Chlamydia||Other: Targeted STI Screening Other: Universally Offered STI Screening||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70000 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||A comparative effectiveness pragmatic trial using a stepped wedge crossover design will be conducted. A stepped wedge design involves the sequential roll-out of an intervention or a sequence of interventions to individuals or sites over multiple time periods. At the end of the study, all sites will have received all interventions, but the order in which sites are enrolled is randomly assigned. Once the final intervention is implemented, that intervention will continue until the end of the study.|
|Masking:||None (Open Label)|
|Official Title:||Improving the Detection of STIs in the Pediatric Emergency Department: A Pragmatic Trial|
|Actual Study Start Date :||July 20, 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
No Intervention: Baseline
Current STI screening rates.
Active Comparator: Targeted STI Screening
Data from the Sexual Health Screen (SHS) will be integrated into the Electronic Health Record (EHR) and will provide Clinical Decision Support (CDS) for GC/CT testing based on SHS-calculated STI risk. Patients will be classified as at high risk for STIs, at risk or low risk if they deny any history of sexual activity. When patients classify as at high risk, clinicians will receive CDS that STI testing is "highly recommended"; when they care for patients who classify as at risk, they will receive CDS that STI testing is "recommended"; when caring for patients who classify as at low risk, they will receive CDS that STI testing "is not necessary at this time." If the clinician chooses to follow the recommendation for screening based on patient's risk assessment, and the patient consents to testing on the tablet device, urine GC/CT testing will be performed.
Other: Targeted STI Screening
GC/CT screening will be offered to those who screen at risk or at high risk for STIs.
Active Comparator: Universally Offered STI Screening
During the universally offered screening intervention, STI screening will be offered to all eligible adolescents, regardless of risk. All eligible patients will also complete the SHS, will be informed of the CDC GC/CT testing recommendations and then be given the option to decline STI testing using the tablet device. During this phase, the SHS results will not be available to the clinician. STI testing recommendations will be based only on the patient's decision to undergo GC/CT testing. Like the process followed in the targeted screening phase, if the clinician follows the CDS that informs the clinician that the patient agreed to GC/CT screening and consequently orders testing, urine GC/CT testing will be performed.
Other: Universally Offered STI Screening
GC/CT screening will be offered to all patients who meet the age eligibility criteria.
- GC/CT testing rates [ Time Frame: Through study completion, an average of 2 years ]Our primary outcome measure will be GC/CT testing rates per 1000 eligible patients.
- Positive GC/CT Rates by Risk Strata [ Time Frame: Through study completion, an average of 2 years ]Comparison of GC/CT positive rates between patients in the high and low risk sexual strata (determined by the patient entered SHS)
- Appropriate Treatment of Positive GC/CT Infections [ Time Frame: Through study completion, an average of 2 years ]The proportion of positive GC/CT cases successfully treated within 14 days.
- GC/CT Detection Rates [ Time Frame: Through study completion, an average of 2 years ]GC/CT detection rates per 1000 eligible patients.
- Patients agreeing to testing [ Time Frame: Through study completion, an average of 2 years ]The proportion of patients who agreed to be tested for GC/CT
- CDS recommendations followed [ Time Frame: Through study completion, an average of 2 years ]The proportion of visits during which the clinician followed the CDS recommendations
- ED Length of Stay [ Time Frame: Through study completion, an average of 2 years ]The length of ED stay for each eligible patient during each phase
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715335
|Contact: Jennifer L Reed, MD, MSfirstname.lastname@example.org|
|Contact: Monika K Goyal, MD, MSCE||202-476-2869||MGoyal@childrensnational.org|
|United States, Colorado|
|Colorado Children's Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Sarah Schmidt, MD email@example.com|
|Principal Investigator: Sarah Schmidt, MD|