Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT03783650
Brief Summary:
The proposed research, building on an ongoing AHRQ-funded research project to prevent pediatric diagnostic errors in primary care (R01HS023608) and using a prospective, cluster-randomized, stepped wedge design, will investigate whether 1) a quality improvement collaborative (QIC) intervention without subspecialist involvement, 2) a QIC with subspecialists and primary care physicians (PCPs) mutually engaged, and/or 3) a hub and spoke co-diagnosis, co-management model where PCPs diagnose and manage pediatric hypertension (HTN) with a supporting subspecialist advisor, reduce errors in pediatric HTN diagnosis and management compared to each other and usual care.
Detailed Description:
Pediatric HTN causes appreciable morbidity in pediatric patients and errors in diagnosis and management are frequent and understudied, jeopardizing pediatric safety in ambulatory settings. Additionally, the gap between the number of pediatric subspecialist providers and the number needed for patient care continues to widen, and it is unclear how to best reduce burden on subspecialists, improve PCP and subspecialist communication, and improve patient outcomes. This research team, with significant experience researching ambulatory pediatric safety, conducting QICs and HTN interventions, identified six large pediatric practice groups in rural, suburban and urban locations that are committed to reducing preventable HTN patient harm, to testing the effectiveness of a QIC to improve PCP HTN diagnosis and management, and to a hub and spoke HTN co-diagnosis and co-management model. The effect demonstrated by this project using a rigorous research design and the new 2017 pediatric HTN guidelines, will motivate pediatric clinics across the country to adopt these newly-identified best practices to improve pediatric HTN care. Primary care pediatricians have an imperative to diagnose and manage HTN and elevated BP (EBP) more accurately and earlier, and to improve interactions with subspecialists to reduce the lifelong preventable harm that results from these chronic conditions. This proposal, will identify a clear implementation strategy for rigorous, evidenced-based pediatric HTN diagnosis and management, and highlight a model to increase primary and subspecialty care integration that can be reproduced across other chronic conditions.
The primary human subjects of this work are the physicians and staff within the primary care pediatric practices and their associated pediatric hypertension subspecialists whose behavior the QIC is attempting to change. In order to know if these practices and subspecialists have changed their behaviors, we will look at patient data. To be included in the data cohort, patients must have a blood pressure (BP) measurement that is elevated (\>= 90th percentile for patient's sex, age, and height, or \>=120/80 (regardless of sex/age/ height) at a healthcare maintenance visit or non-acute care visit (e.g. chronic disease follow-up visit). The following patients would be excluded from the data cohort:
* Prior hypertension or elevated BP diagnosis. Patient can have prior elevated BP measurements as long as no diagnosis has been made
* BP\>95th percentile + 30mm or \>180/120 or symptomatic patient
* Prior diagnosis of congenital heart disease, chronic kidney disease, urologic disease (e.g. posterior urethral valve, vesicoureteral reflux) or organ transplant,
* Previously included in BP-CATCH data entry
* Acute care visit (e.g., fever, viral illness, asthma attack, pain in any body part, etc.)
Study:
NCT03783650
Study Brief:
Protocol Section:
NCT03783650