N/A
N=4,350
Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)
Diagnostic Errors
Bottom Line
View on ClinicalTrials.gov: NCT02798354 ↗Enrolled (actual)
4,350
Serious AEs
—
Results posted
Dec 2019
Primary outcome: Primary: Number of Adolescents Diagnosed With Depression Seen in Well Child Visits — 233; 443 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Quality Improvement Collaborative (Behavioral)
- Age
- Adult, Older Adult · 26+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adolescents Diagnosed With Depression Seen in Well Child Visits |
233; 443 | <0.0001 sig |
| PRIMARY Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers |
969; 1378 | <0.0001 sig |
| PRIMARY Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay |
1273; 1329 | 0.302 |
| SECONDARY Number of Adolescents With Mental Health Addressed During Their Well Child Visit |
1782; 3075 | <0.0001 sig |
| SECONDARY Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart |
1233; 1681 | <0.0001 sig |
| SECONDARY Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider |
1013; 1394 | <0.0001 sig |
| SECONDARY Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider |
1292; 1339 | 0.922 |
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 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.
Eligibility Criteria
Inclusion Criteria
- The investigators will include 30 primary care pediatric practices that are part of the American Academy of Pediatrics' QuIIN (Quality Improvement Innovation Networks) organization. The second wave will recruit 15 additional practices.
- Practices must have sufficient volumes of adolescent well child visits (17 per month) and all well child visits (30 per month), and be able to query their EHR systems in order to be included in the study
Data sourced from ClinicalTrials.gov (NCT02798354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.