Clinical trial NCT03783650: Boosting Primary Care Awareness and Treatment of Childhood Hypertension
Official title: BP-CATCH: Boosting Primary Care Awareness and Treatment of Childhood Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pediatric Hypertension
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2018-12-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.)

Eligibility criteria: Inclusion:

* Primary care pediatric practices who see children ages 3-22 years old.
* Practice must be able to field a 3-person core improvement team who can participate in the quality improvement collaborative.

Exclusion:

- Non-pediatric practices

Primary outcomes:
measure: Number of patients without all correct diagnostic and management decisions
timeFrame: average 34 months
Secondary outcomes:
measure: Number of patients without re-measuring of BP twice in clinic via auscultation
timeFrame: average 34 months
measure: Number of patients without weight counseling management decisions
timeFrame: average 34 months
measure: Number of patients without lifestyle modification counseling management decisions
timeFrame: average 34 months
measure: Number of patients without nutrition counseling management decisions
timeFrame: average 34 months
measure: Number of patients without repeat BP measurement visits appropriately timed
timeFrame: average 34 months
measure: Number of patients without initial laboratory workup diagnostic decisions
timeFrame: average 34 months
measure: Number of patients without Subspecialist referral
timeFrame: average 34 months
measure: Number of patients without echocardiogram workup diagnostic decisions
timeFrame: average 34 months
measure: Number of patients without echocardiogram diagnostic decisions
timeFrame: average 34 months
measure: Number of patients without radiology diagnostic decisions
timeFrame: average 34 months
measure: BPs measured correctly that met specific criteria
timeFrame: average 34 months
measure: Time to third new next available subspecialist appointment
timeFrame: average 33 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine and The Children's Hospital at Montefiore
name: Michael L Rinke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rea CJ, Brady TM, Bundy DG, Heo M, Faro E, Giuliano K, Goilav B, Kelly P, Orringer K, Tarini BA, Twombley K, Rinke ML. Pediatrician Adherence to Guidelines for Diagnosis and Management of High Blood Pressure. J Pediatr. 2022 Mar;242:12-17.e1. doi: 10.1016/j.jpeds.2021.11.008. Epub 2021 Nov 10.