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Completed Not applicable Interventional Results available

Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)

ClinicalTrials.gov ID: NCT02798354

Public ClinicalTrials.gov record NCT02798354. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 3:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Reducing Diagnostic Errors in Primary Care Pediatrics

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 during those eight months. Following those eight months, the groups will continue intervening on their first error, begin intervening on the error they were a control site for, and begin collecting data on the third error for which they will be a control site for. Finally, in the final eight months, all groups will intervene on all three errors. A second wave of practices will be recruited to join the groups after eight months and will only intervene on two of the three errors.

Study identification

NCT ID
NCT02798354
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Montefiore Medical Center
Other
Enrollment
13,853 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
26 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2015
Primary completion
Oct 30, 2017
Completion
Oct 30, 2017
Last update posted
Dec 15, 2019

2015 – 2017

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
American Academy of Pediatrics Elk Grove Village Illinois 60007

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02798354, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 15, 2019 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02798354 live on ClinicalTrials.gov.

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