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Trial record 16 of 38 for:    Recruiting, Not yet recruiting, Available Studies | Chlamydia

Adolescent Sexually Transmitted Infection Screening in the Emergency Department (STI)

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ClinicalTrials.gov Identifier: NCT03715335
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
Medstar Health Research Institute
Nationwide Children's Hospital
Children's Research Institute
Children's Hospital of Philadelphia
Ann & Robert H Lurie Children's Hospital of Chicago
Children's Hospital and Health System Foundation, Wisconsin
Texas Children's Hospital
Children's Hospital Colorado
University of Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jennifer Reed, Children's Hospital Medical Center, Cincinnati

Brief Summary:
Sexually transmitted infections (STIs) are highly prevalent among adolescents. Despite established principles for STI control, clinical practices related to screening and diagnosis, treatment, and prevention of STIs among adolescents are suboptimal. There is an urgent need to expand our screening programs to nontraditional healthcare settings such as emergency departments (ED) to reach those adolescents who would otherwise not receive preventive healthcare, and to determine the most efficient and cost-effective method for providing this screening. The goal of this study is to leverage our recent insights obtained from single center ED-based adolescent gonorrhea and chlamydia screening research and apply them across a national pediatric ED research network to determine the most clinically effective and cost-effective screening approach for adolescents when implemented into a real-world clinical setting through a pragmatic trial. This will be accomplished through a network of children's hospital EDs with a track record of robust research collaboration (Pediatric Emergency Care Applied Research Network or PECARN). This intervention will rely on an innovative approach that electronically integrates patient-reported data to guide clinical decision support. The investigators will apply human factors modeling methods to perform ED workflow evaluations at each participating pediatric ED to determine the most efficient way to integrate the screening process into everyday clinical care. Following these analyses, the investigators will conduct a comparative effectiveness pragmatic trial of targeted STI screening (screening only those disclosing high risk sexual behavior) versus universally-offered STI screening (offered to all, regardless of risk) through electronic integration of patient reported data for provision of clinical decision support. The investigators will then develop decision analytic models to evaluate the cost-effectiveness of targeted screening compared to universally offered screening.

Condition or disease Intervention/treatment Phase
Gonorrhea Chlamydia Other: Targeted STI Screening Other: Universally Offered STI Screening Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70000 participants
Allocation: Randomized
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)
Primary Purpose: Screening
Official Title: Improving the Detection of STIs in the Pediatric Emergency Department: A Pragmatic Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. GC/CT Detection Rates [ Time Frame: Through study completion, an average of 2 years ]
    GC/CT detection rates per 1000 eligible patients.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 15-21 years of age

Exclusion Criteria

  • unable to understand English
  • critically ill
  • cognitive impairment or altered mental status
  • unable to provide consent for completion of the sexual health screen and STI screening.

Information from the National Library of Medicine

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


Contacts
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Contact: Jennifer L Reed, MD, MS 513-636-7966 jennifer.reed@cchmc.org
Contact: Monika K Goyal, MD, MSCE 202-476-2869 MGoyal@childrensnational.org

Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Medstar Health Research Institute
Nationwide Children's Hospital
Children's Research Institute
Children's Hospital of Philadelphia
Ann & Robert H Lurie Children's Hospital of Chicago
Children's Hospital and Health System Foundation, Wisconsin
Texas Children's Hospital
Children's Hospital Colorado
University of Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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Responsible Party: Jennifer Reed, Professor of Clinical Pediatrics, Attending Physician Division of Emergency Medicine, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03715335     History of Changes
Other Study ID Numbers: CIN001-STI Screening
1R01HD094213-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Reed, Children's Hospital Medical Center, Cincinnati:
Screening
Emergency Department
Adolescents
Sexually Transmitted Infections
Sexually Transmitted Diseases
Cost Effectiveness
Pragmatic Trial

Additional relevant MeSH terms:
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Emergencies
Gonorrhea
Sexually Transmitted Diseases
Disease Attributes
Pathologic Processes
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Genital Diseases, Female
Virus Diseases