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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783650
Recruitment Status : Terminated (Study halted prematurely and will not resume due to the COVID-19 pandemic.)
First Posted : December 21, 2018
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Michael Rinke, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE December 19, 2018
First Posted Date  ICMJE December 21, 2018
Last Update Posted Date September 3, 2020
Actual Study Start Date  ICMJE September 1, 2018
Actual Primary Completion Date July 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
Number of patients without all correct diagnostic and management decisions [ Time Frame: average 34 months ]
Number of patients without all correct diagnostic and management decisions per 100 patients with measured elevated BP
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • Number of patients without re-measuring of BP twice in clinic via auscultation [ Time Frame: average 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 weight counseling management decisions [ Time Frame: average 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 decisions [ Time Frame: average 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 nutrition counseling management decisions [ Time Frame: average 34 months ]
    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 [ Time Frame: average 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 decisions [ Time Frame: average 34 months ]
    Number of patients without initial laboratory workup at specified points per 100 patients with measured elevated BP
  • Number of patients without Subspecialist referral [ Time Frame: average 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 decisions [ Time Frame: average 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 decisions [ Time Frame: average 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 decisions [ Time Frame: average 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 criteria [ Time Frame: average 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 appointment [ Time Frame: average 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Boosting Primary Care Awareness and Treatment of Childhood Hypertension
Official Title  ICMJE BP-CATCH: Boosting Primary Care Awareness and Treatment of Childhood Hypertension
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Hypertension
Intervention  ICMJE
  • Behavioral: Control condition
    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.
  • Behavioral: QIC with PCP and without subspecialist
    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).
  • Behavioral: QIC with Subspecialist
    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).
  • Behavioral: Hub and Spoke co-management
    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.
  • Behavioral: Sustainability of changes
    Practices will sustain their changes, illustrating the durability of these system changes even after QIC completion and without central feedback and regular meetings.
Study Arms  ICMJE
  • Experimental: Cohort 1
    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
    Interventions:
    • Behavioral: QIC with PCP and without subspecialist
    • Behavioral: QIC with Subspecialist
    • Behavioral: Hub and Spoke co-management
    • Behavioral: Sustainability of changes
  • Active Comparator: Cohort 2
    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
    Interventions:
    • Behavioral: Control condition
    • Behavioral: QIC with PCP and without subspecialist
    • Behavioral: QIC with Subspecialist
    • Behavioral: Hub and Spoke co-management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 20, 2018)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 14, 2020
Actual Primary Completion Date July 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03783650
Other Study ID Numbers  ICMJE 2018-9287
R01HS026239 ( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Rinke, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Michael L Rinke, MD Albert Einstein College of Medicine and The Children's Hospital at Montefiore
PRS Account Montefiore Medical Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP