<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03783650</url>
  </required_header>
  <id_info>
    <org_study_id>2018-9287</org_study_id>
    <secondary_id>R01HS026239</secondary_id>
    <nct_id>NCT03783650</nct_id>
  </id_info>
  <brief_title>Boosting Primary Care Awareness and Treatment of Childhood Hypertension</brief_title>
  <acronym>BP-CATCH</acronym>
  <official_title>BP-CATCH: Boosting Primary Care Awareness and Treatment of Childhood Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed research, building on an ongoing AHRQ-funded research project to prevent&#xD;
      pediatric diagnostic errors in primary care (R01HS023608) and using a prospective,&#xD;
      cluster-randomized, stepped wedge design, will investigate whether 1) a quality improvement&#xD;
      collaborative (QIC) intervention without subspecialist involvement, 2) a QIC with&#xD;
      subspecialists and primary care physicians (PCPs) mutually engaged, and/or 3) a hub and spoke&#xD;
      co-diagnosis, co-management model where PCPs diagnose and manage pediatric hypertension (HTN)&#xD;
      with a supporting subspecialist advisor, reduce errors in pediatric HTN diagnosis and&#xD;
      management compared to each other and usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pediatric HTN causes appreciable morbidity in pediatric patients and errors in diagnosis and&#xD;
      management are frequent and understudied, jeopardizing pediatric safety in ambulatory&#xD;
      settings. Additionally, the gap between the number of pediatric subspecialist providers and&#xD;
      the number needed for patient care continues to widen, and it is unclear how to best reduce&#xD;
      burden on subspecialists, improve PCP and subspecialist communication, and improve patient&#xD;
      outcomes. This research team, with significant experience researching ambulatory pediatric&#xD;
      safety, conducting QICs and HTN interventions, identified six large pediatric practice groups&#xD;
      in rural, suburban and urban locations that are committed to reducing preventable HTN patient&#xD;
      harm, to testing the effectiveness of a QIC to improve PCP HTN diagnosis and management, and&#xD;
      to a hub and spoke HTN co-diagnosis and co-management model. The effect demonstrated by this&#xD;
      project using a rigorous research design and the new 2017 pediatric HTN guidelines, will&#xD;
      motivate pediatric clinics across the country to adopt these newly-identified best practices&#xD;
      to improve pediatric HTN care. Primary care pediatricians have an imperative to diagnose and&#xD;
      manage HTN and elevated BP (EBP) more accurately and earlier, and to improve interactions&#xD;
      with subspecialists to reduce the lifelong preventable harm that results from these chronic&#xD;
      conditions. This proposal, will identify a clear implementation strategy for rigorous,&#xD;
      evidenced-based pediatric HTN diagnosis and management, and highlight a model to increase&#xD;
      primary and subspecialty care integration that can be reproduced across other chronic&#xD;
      conditions.&#xD;
&#xD;
      The primary human subjects of this work are the physicians and staff within the primary care&#xD;
      pediatric practices and their associated pediatric hypertension subspecialists whose behavior&#xD;
      the QIC is attempting to change. In order to know if these practices and subspecialists have&#xD;
      changed their behaviors, we will look at patient data. To be included in the data cohort,&#xD;
      patients must have a blood pressure (BP) measurement that is elevated (&gt;= 90th percentile for&#xD;
      patient's sex, age, and height, or &gt;=120/80 (regardless of sex/age/ height) at a healthcare&#xD;
      maintenance visit or non-acute care visit (e.g. chronic disease follow-up visit). The&#xD;
      following patients would be excluded from the data cohort:&#xD;
&#xD;
        -  Prior hypertension or elevated BP diagnosis. Patient can have prior elevated BP&#xD;
           measurements as long as no diagnosis has been made&#xD;
&#xD;
        -  BP&gt;95th percentile + 30mm or &gt;180/120 or symptomatic patient&#xD;
&#xD;
        -  Prior diagnosis of congenital heart disease, chronic kidney disease, urologic disease&#xD;
           (e.g. posterior urethral valve, vesicoureteral reflux) or organ transplant,&#xD;
&#xD;
        -  Previously included in BP-CATCH data entry&#xD;
&#xD;
        -  Acute care visit (e.g., fever, viral illness, asthma attack, pain in any body part,&#xD;
           etc.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study halted prematurely and will not resume due to the COVID-19 pandemic.&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">July 14, 2020</completion_date>
  <primary_completion_date type="Actual">July 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients without all correct diagnostic and management decisions</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without all correct diagnostic and management decisions per 100 patients with measured elevated BP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients without re-measuring of BP twice in clinic via auscultation</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without re-measuring of BP twice in clinic via auscultation at specified points per 100 patients with measured elevated BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients without weight counseling management decisions</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without weight counseling at specified points per 100 patients with measured elevated BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients without lifestyle modification counseling management decisions</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without lifestyle modification counseling management decisions at specified points per 100 patients with measured elevated BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients without nutrition counseling management decisions</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without nutrition counseling management decisions at specified points per 100 patients with measured elevated BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients without repeat BP measurement visits appropriately timed</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without repeat BP measurement visits appropriately timed at specified points per 100 patients with measured elevated BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients without initial laboratory workup diagnostic decisions</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without initial laboratory workup at specified points per 100 patients with measured elevated BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients without Subspecialist referral</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without Subspecialist referral at specified points per 100 patients with measured elevated BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients without echocardiogram workup diagnostic decisions</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without echocardiogram workup diagnostic decisions at specified points per 100 patients with measured elevated BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients without echocardiogram diagnostic decisions</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without echocardiogram diagnostic decisions at specified points per 100 patients with measured elevated BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients without radiology diagnostic decisions</measure>
    <time_frame>average 34 months</time_frame>
    <description>Number of patients without radiology diagnostic decisions at specified points per 100 patients with measured elevated BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BPs measured correctly that met specific criteria</measure>
    <time_frame>average 34 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to third new next available subspecialist appointment</measure>
    <time_frame>average 33 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Pediatric Hypertension</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0-6 months: Quality Improvement Collaborative (QIC) with PCP and without subspecialist, Registry &amp; 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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0-6 months: Control condition Usual Care and Registry &amp; 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</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control condition</intervention_name>
    <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.</description>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>QIC with PCP and without subspecialist</intervention_name>
    <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).</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>QIC with Subspecialist</intervention_name>
    <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).</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hub and Spoke co-management</intervention_name>
    <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.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sustainability of changes</intervention_name>
    <description>Practices will sustain their changes, illustrating the durability of these system changes even after QIC completion and without central feedback and regular meetings.</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Primary care pediatric practices who see children ages 3-22 years old.&#xD;
&#xD;
          -  Practice must be able to field a 3-person core improvement team who can participate in&#xD;
             the quality improvement collaborative.&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
        - Non-pediatric practices&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael L Rinke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College of Medicine and The Children's Hospital at Montefiore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Albert Einstein College of Medicine</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Michael Rinke</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 29, 2022</submitted>
    <returned>May 10, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03783650
org study id: 2018-9287
secondary id: R01HS026239
nct id: NCT03783650
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients without all correct diagnostic and management decisions
time frame: average 34 months
description: Number of patients without all correct diagnostic and management decisions per 100 patients with measured elevated BP
measure: Number of patients without re-measuring of BP twice in clinic via auscultation
time frame: average 34 months
description: Number of patients without re-measuring of BP twice in clinic via auscultation at specified points per 100 patients with measured elevated BP
measure: Number of patients without weight counseling management decisions
time frame: average 34 months
description: Number of patients without weight counseling at specified points per 100 patients with measured elevated BP
measure: Number of patients without lifestyle modification counseling management decisions
time frame: average 34 months
description: Number of patients without lifestyle modification counseling management decisions at specified points per 100 patients with measured elevated BP
measure: Number of patients without nutrition counseling management decisions
time frame: average 34 months
description: Number of patients without nutrition counseling management decisions at specified points per 100 patients with measured elevated BP
measure: Number of patients without repeat BP measurement visits appropriately timed
time frame: average 34 months
description: Number of patients without repeat BP measurement visits appropriately timed at specified points per 100 patients with measured elevated BP
measure: Number of patients without initial laboratory workup diagnostic decisions
time frame: average 34 months
description: Number of patients without initial laboratory workup at specified points per 100 patients with measured elevated BP
measure: Number of patients without Subspecialist referral
time frame: average 34 months
description: Number of patients without Subspecialist referral at specified points per 100 patients with measured elevated BP
measure: Number of patients without echocardiogram workup diagnostic decisions
time frame: average 34 months
description: Number of patients without echocardiogram workup diagnostic decisions at specified points per 100 patients with measured elevated BP
measure: Number of patients without echocardiogram diagnostic decisions
time frame: average 34 months
description: Number of patients without echocardiogram diagnostic decisions at specified points per 100 patients with measured elevated BP
measure: Number of patients without radiology diagnostic decisions
time frame: average 34 months
description: Number of patients without radiology diagnostic decisions at specified points per 100 patients with measured elevated BP
measure: BPs measured correctly that met specific criteria
time frame: average 34 months
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
measure: Time to third new next available subspecialist appointment
time frame: average 33 months
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.
arm group label: Cohort 1
arm group type: Experimental
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 group label: Cohort 2
arm group type: Active Comparator
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: Control condition
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.
arm group label: Cohort 2
intervention type: Behavioral
intervention name: QIC with PCP and without subspecialist
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).
arm group label: Cohort 1
arm group label: Cohort 2
intervention type: Behavioral
intervention name: QIC with Subspecialist
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).
arm group label: Cohort 1
arm group label: Cohort 2
intervention type: Behavioral
intervention name: Hub and Spoke co-management
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.
arm group label: Cohort 1
arm group label: Cohort 2
intervention type: Behavioral
intervention name: Sustainability of changes
description: Practices will sustain their changes, illustrating the durability of these system changes even after QIC completion and without central feedback and regular meetings.
arm group label: Cohort 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael L Rinke, MD
role: Principal Investigator
affiliation: Albert Einstein College of Medicine and The Children's Hospital at Montefiore
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Michael Rinke
investigator title: Associate Professor of Pediatrics
mesh term: Hypertension
sharing ipd: No
submitted: June 29, 2022
returned: May 10, 2023