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Boosting Primary Care Awareness and Treatment of Childhood Hypertension (BP-CATCH)

Primary Purpose

Pediatric Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control condition
QIC with PCP and without subspecialist
QIC with Subspecialist
Hub and Spoke co-management
Sustainability of changes
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cohort 1

Cohort 2

Arm Description

0-6 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

0-6 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients without re-measuring of BP twice in clinic via auscultation
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 weight counseling management decisions
Number of patients without weight counseling at specified points per 100 patients with measured elevated BP
Number of patients without lifestyle modification counseling management decisions
Number of patients without lifestyle modification counseling management decisions at specified points per 100 patients with measured elevated BP
Number of patients without nutrition counseling management decisions
Number of patients without nutrition counseling management decisions at specified points per 100 patients with measured elevated BP
Number of patients without repeat BP measurement visits appropriately timed
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 decisions
Number of patients without initial laboratory workup at specified points per 100 patients with measured elevated BP
Number of patients without Subspecialist referral
Number of patients without Subspecialist referral at specified points per 100 patients with measured elevated BP
Number of patients without echocardiogram workup diagnostic decisions
Number of patients without echocardiogram workup diagnostic decisions at specified points per 100 patients with measured elevated BP
Number of patients without echocardiogram diagnostic decisions
Number of patients without echocardiogram diagnostic decisions at specified points per 100 patients with measured elevated BP
Number of patients without radiology diagnostic decisions
Number of patients without radiology diagnostic decisions at specified points per 100 patients with measured elevated BP
BPs measured correctly that met specific criteria
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 appointment
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.

Full Information

First Posted
December 19, 2018
Last Updated
September 1, 2020
Sponsor
Montefiore Medical Center
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT03783650
Brief Title
Boosting Primary Care Awareness and Treatment of Childhood Hypertension
Acronym
BP-CATCH
Official Title
BP-CATCH: Boosting Primary Care Awareness and Treatment of Childhood Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Study halted prematurely and will not resume due to the COVID-19 pandemic.
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
July 14, 2020 (Actual)
Study Completion Date
July 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
0-6 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
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
0-6 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
Intervention Type
Behavioral
Intervention Name(s)
Control condition
Intervention Description
Practices will submit control data and not receive centralized data feedback. They will also begin tracking data on a HTN registry and learn how to ensure accurate BP measurement is completed in their clinic.
Intervention Type
Behavioral
Intervention Name(s)
QIC with PCP and without subspecialist
Intervention Description
During this phase, practice will begin working on improving HTN practices within their clinic via a QIC, while the other cohort will act as a control (usual care) with data collection. They will attend an initial 1-day interactive video webinar learning session where they will learn QI methodology, enhance and practice QI skills, identify local 30-60 day aims to improve local HTN practices and increase their understanding of pediatric HTN. They will also begin tracking data on a HTN registry and learn how to ensure accurate BP measurement is completed in their clinic. They will participate in QI coaching, monthly video conferences, and monthly mini-root cause analyses (Mini-RCAs).
Intervention Type
Behavioral
Intervention Name(s)
QIC with Subspecialist
Intervention Description
Practices will integrate their HTN subspecialist into the QIC and focus on issues at the boundary of PCP and subspecialty care (e.g. pre-referral work-up, communication across providers, and time for next available appointment).
Intervention Type
Behavioral
Intervention Name(s)
Hub and Spoke co-management
Intervention Description
Practices will continue QIC components and implement a hub and spoke model, where the PCP diagnoses and provides definitive management for pediatric HTN with subspecialist support.
Intervention Type
Behavioral
Intervention Name(s)
Sustainability of changes
Intervention Description
Practices will sustain their changes, illustrating the durability of these system changes even after QIC completion and without central feedback and regular meetings.
Primary Outcome Measure Information:
Title
Number of patients without all correct diagnostic and management decisions
Description
Number of patients without all correct diagnostic and management decisions per 100 patients with measured elevated BP
Time Frame
average 34 months
Secondary Outcome Measure Information:
Title
Number of patients without re-measuring of BP twice in clinic via auscultation
Description
Number of patients without re-measuring of BP twice in clinic via auscultation at specified points per 100 patients with measured elevated BP
Time Frame
average 34 months
Title
Number of patients without weight counseling management decisions
Description
Number of patients without weight counseling at specified points per 100 patients with measured elevated BP
Time Frame
average 34 months
Title
Number of patients without lifestyle modification counseling management decisions
Description
Number of patients without lifestyle modification counseling management decisions at specified points per 100 patients with measured elevated BP
Time Frame
average 34 months
Title
Number of patients without nutrition counseling management decisions
Description
Number of patients without nutrition counseling management decisions at specified points per 100 patients with measured elevated BP
Time Frame
average 34 months
Title
Number of patients without repeat BP measurement visits appropriately timed
Description
Number of patients without repeat BP measurement visits appropriately timed at specified points per 100 patients with measured elevated BP
Time Frame
average 34 months
Title
Number of patients without initial laboratory workup diagnostic decisions
Description
Number of patients without initial laboratory workup at specified points per 100 patients with measured elevated BP
Time Frame
average 34 months
Title
Number of patients without Subspecialist referral
Description
Number of patients without Subspecialist referral at specified points per 100 patients with measured elevated BP
Time Frame
average 34 months
Title
Number of patients without echocardiogram workup diagnostic decisions
Description
Number of patients without echocardiogram workup diagnostic decisions at specified points per 100 patients with measured elevated BP
Time Frame
average 34 months
Title
Number of patients without echocardiogram diagnostic decisions
Description
Number of patients without echocardiogram diagnostic decisions at specified points per 100 patients with measured elevated BP
Time Frame
average 34 months
Title
Number of patients without radiology diagnostic decisions
Description
Number of patients without radiology diagnostic decisions at specified points per 100 patients with measured elevated BP
Time Frame
average 34 months
Title
BPs measured correctly that met specific criteria
Description
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 Frame
average 34 months
Title
Time to third new next available subspecialist appointment
Description
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.
Time Frame
average 33 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Rinke, MD
Organizational Affiliation
Albert Einstein College of Medicine and The Children's Hospital at Montefiore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34774574
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.
Results Reference
derived

Learn more about this trial

Boosting Primary Care Awareness and Treatment of Childhood Hypertension

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