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Boosting Primary Care Awareness and Treatment of Childhood Hypertension

Not Applicable
Terminated
Conditions
Pediatric Hypertension
Interventions
Behavioral: QIC with PCP and without subspecialist
Behavioral: Control condition
Behavioral: QIC with Subspecialist
Behavioral: Hub and Spoke co-management
Behavioral: Sustainability of changes
Registration Number
NCT03783650
Lead Sponsor
Montefiore Medical Center
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.)

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
64
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cohort 1QIC with Subspecialist0-6 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist, Registry \& BP measurement 7-12 months: QIC with Subspecialist to improve communication and standardize, 13-18 months: Hub and Spoke co-management QIC with Primary care and Subspecialist 19-24 months: Sustainability of changes
Cohort 1Sustainability of changes0-6 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist, Registry \& BP measurement 7-12 months: QIC with Subspecialist to improve communication and standardize, 13-18 months: Hub and Spoke co-management QIC with Primary care and Subspecialist 19-24 months: Sustainability of changes
Cohort 1QIC with PCP and without subspecialist0-6 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist, Registry \& BP measurement 7-12 months: QIC with Subspecialist to improve communication and standardize, 13-18 months: Hub and Spoke co-management QIC with Primary care and Subspecialist 19-24 months: Sustainability of changes
Cohort 1Hub and Spoke co-management0-6 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist, Registry \& BP measurement 7-12 months: QIC with Subspecialist to improve communication and standardize, 13-18 months: Hub and Spoke co-management QIC with Primary care and Subspecialist 19-24 months: Sustainability of changes
Cohort 2Hub and Spoke co-management0-6 months: Control condition Usual Care and Registry \& BP measurement, 7-12 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist 13-18 months: QIC with Subspecialist to improve communication and standardize 19-24 months: Hub and Spoke co-management QIC with Primary care and Subspecialist
Cohort 2Control condition0-6 months: Control condition Usual Care and Registry \& BP measurement, 7-12 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist 13-18 months: QIC with Subspecialist to improve communication and standardize 19-24 months: Hub and Spoke co-management QIC with Primary care and Subspecialist
Cohort 2QIC with PCP and without subspecialist0-6 months: Control condition Usual Care and Registry \& BP measurement, 7-12 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist 13-18 months: QIC with Subspecialist to improve communication and standardize 19-24 months: Hub and Spoke co-management QIC with Primary care and Subspecialist
Cohort 2QIC with Subspecialist0-6 months: Control condition Usual Care and Registry \& BP measurement, 7-12 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist 13-18 months: QIC with Subspecialist to improve communication and standardize 19-24 months: Hub and Spoke co-management QIC with Primary care and Subspecialist
Primary Outcome Measures
NameTimeMethod
Number of patients without all correct diagnostic and management decisionsaverage 34 months

Number of patients without all correct diagnostic and management decisions per 100 patients with measured elevated BP

Secondary Outcome Measures
NameTimeMethod
Number of patients without re-measuring of BP twice in clinic via auscultationaverage 34 months

Number of patients without re-measuring of BP twice in clinic via auscultation at specified points per 100 patients with measured elevated BP

Number of patients without nutrition counseling management decisionsaverage 34 months

Number of patients without nutrition counseling management decisions at specified points per 100 patients with measured elevated BP

Number of patients without weight counseling management decisionsaverage 34 months

Number of patients without weight counseling at specified points per 100 patients with measured elevated BP

Number of patients without lifestyle modification counseling management decisionsaverage 34 months

Number of patients without lifestyle modification counseling management decisions at specified points per 100 patients with measured elevated BP

Number of patients without repeat BP measurement visits appropriately timedaverage 34 months

Number of patients without repeat BP measurement visits appropriately timed at specified points per 100 patients with measured elevated BP

Number of patients without initial laboratory workup diagnostic decisionsaverage 34 months

Number of patients without initial laboratory workup at specified points per 100 patients with measured elevated BP

Number of patients without Subspecialist referralaverage 34 months

Number of patients without Subspecialist referral at specified points per 100 patients with measured elevated BP

Number of patients without echocardiogram workup diagnostic decisionsaverage 34 months

Number of patients without echocardiogram workup diagnostic decisions at specified points per 100 patients with measured elevated BP

Number of patients without echocardiogram diagnostic decisionsaverage 34 months

Number of patients without echocardiogram diagnostic decisions at specified points per 100 patients with measured elevated BP

Number of patients without radiology diagnostic decisionsaverage 34 months

Number of patients without radiology diagnostic decisions at specified points per 100 patients with measured elevated BP

BPs measured correctly that met specific criteriaaverage 34 months

Number of measured BPs correctly per 100 patients with BP measured with appropriately screened patient, patient position, cuff size, inflation, BP percentiles correctly documented and interpreted

Time to third new next available subspecialist appointmentaverage 33 months

Third new next available appointment for pediatric patients to subspecialist clinics in order to assess the effects of pediatric primary care providers referring and managing different types of patients with hypertension.

Trial Locations

Locations (1)

Albert Einstein College of Medicine

🇺🇸

Bronx, New York, United States

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