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Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)
NCT02798354 · View on ClinicalTrials.gov ↗
Study Summary
The proposal will focus on 3 specific, high-risk, pediatric ambulatory diagnostic errors each representing a unique dimension of diagnostic assessment: evaluation of symptoms, evaluation of signs and follow-up of diagnostic tests. Adolescent depression (i.e. symptoms) affects nearly 10% of teenagers, is misdiagnosed in almost 75% of adolescents and causes significant morbidity. Pediatric elevated blood pressure (signs) is misdiagnosed in 74-87% of patients, often due to inaccurate application of blood pressure parameters that change based on age, gender and height. Actionable pediatric laboratory values (diagnostic tests) are potentially delayed up to 26% of the time in preliminary investigations and 7-65% in adults, leading to harm and malpractice claims. The investigators propose to conduct a multisite, prospective, stepped wedge cluster randomized trial testing a quality improvement collaborative (QIC) intervention within the American Academy of Pediatrics' Quality Improvement Innovation Networks (QuIIN) to reduce the incidence of pediatric primary care diagnostic errors. QuIIN is a national network of over 300 primary care practices, ranging from tertiary care academic medical centers to single practitioner private practices, interested in and experienced with QICs. Because many processes are likely to be common across diagnostic errors in outpatient settings, a multifaceted intervention, such as a QIC, has a high likelihood of success and broad applicability across populations. Preparatory inquiries to QuIIN primary care providers suggest high interest in reducing these 3 diagnostic errors and provider agreement with randomization to evaluate diagnostic error interventions. Practices will be randomized to one of three groups, with each group collecting retrospective baseline data on one error above, and then intervening to reduce that error during the first eight months. Each group will concurrently collect control data on an error they are not intervening on
Conditions Studied
Interventions
- BEHAVIORAL Quality Improvement Collaborative
Study Locations (1)
Illinois
- American Academy of Pediatrics — Elk Grove Village
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13,853 participants |
| Start Date | 2015-06-01 |
| Est. Completion | 2017-10-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02798354
The ClinicalTrials.gov registry entry for NCT02798354 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 13,853 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diagnostic Errors appearing as the primary indexed condition, and to 1 intervention — of which Quality Improvement Collaborative is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02798354 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02798354 about?
NCT02798354 is a clinical study titled "Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)". The proposal will focus on 3 specific, high-risk, pediatric ambulatory diagnostic errors each representing a unique dimension of diagnostic assessment: evaluation of symptoms, evaluation of signs and follow-up of diagnostic tests. Adolescent depression (i.e. symptoms) affects nearly 10% of teenagers...
What is the current status of trial NCT02798354?
This trial is currently completed. It is a NA study. The enrollment target is 13,853 participants. The study started on 2015-06-01. Estimated completion is 2017-10-31.
What conditions does trial NCT02798354 study?
This clinical trial studies the following conditions: Diagnostic Errors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02798354?
The interventions under investigation include: Quality Improvement Collaborative (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02798354?
This trial is sponsored by Montefiore Medical Center, which has 280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02798354 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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