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.
Brief Title
Boosting Primary Care Awareness and Treatment of Childhood Hypertension
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.)
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.)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pediatric Hypertension
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 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
Inclusion 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 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03783650
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-9287
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
BP-CATCH: Boosting Primary Care Awareness and Treatment of Childhood Hypertension
Primary Outcomes
Outcome Description
Number of patients without all correct diagnostic and management decisions per 100 patients with measured elevated BP
Outcome Measure
Number of patients without all correct diagnostic and management decisions
Outcome Time Frame
average 34 months
Secondary Ids
Secondary Id
R01HS026239
Secondary Outcomes
Outcome Description
Number of patients without re-measuring of BP twice in clinic via auscultation at specified points per 100 patients with measured elevated BP
Outcome Time Frame
average 34 months
Outcome Measure
Number of patients without re-measuring of BP twice in clinic via auscultation
Outcome Description
Number of patients without weight counseling at specified points per 100 patients with measured elevated BP
Outcome Time Frame
average 34 months
Outcome Measure
Number of patients without weight counseling management decisions
Outcome Description
Number of patients without lifestyle modification counseling management decisions at specified points per 100 patients with measured elevated BP
Outcome Time Frame
average 34 months
Outcome Measure
Number of patients without lifestyle modification counseling management decisions
Outcome Description
Number of patients without nutrition counseling management decisions at specified points per 100 patients with measured elevated BP
Outcome Time Frame
average 34 months
Outcome Measure
Number of patients without nutrition counseling management decisions
Outcome Description
Number of patients without repeat BP measurement visits appropriately timed at specified points per 100 patients with measured elevated BP
Outcome Time Frame
average 34 months
Outcome Measure
Number of patients without repeat BP measurement visits appropriately timed
Outcome Description
Number of patients without initial laboratory workup at specified points per 100 patients with measured elevated BP
Outcome Time Frame
average 34 months
Outcome Measure
Number of patients without initial laboratory workup diagnostic decisions
Outcome Description
Number of patients without Subspecialist referral at specified points per 100 patients with measured elevated BP
Outcome Time Frame
average 34 months
Outcome Measure
Number of patients without Subspecialist referral
Outcome Description
Number of patients without echocardiogram workup diagnostic decisions at specified points per 100 patients with measured elevated BP
Outcome Time Frame
average 34 months
Outcome Measure
Number of patients without echocardiogram workup diagnostic decisions
Outcome Description
Number of patients without echocardiogram diagnostic decisions at specified points per 100 patients with measured elevated BP
Outcome Time Frame
average 34 months
Outcome Measure
Number of patients without echocardiogram diagnostic decisions
Outcome Description
Number of patients without radiology diagnostic decisions at specified points per 100 patients with measured elevated BP
Outcome Time Frame
average 34 months
Outcome Measure
Number of patients without radiology diagnostic decisions
Outcome 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
Outcome Time Frame
average 34 months
Outcome Measure
BPs measured correctly that met specific criteria
Outcome 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.
Outcome Time Frame
average 33 months
Outcome Measure
Time to third new next available subspecialist appointment
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michael Rinke
Investigator Email
mrinke@montefiore.org
Investigator Phone
718-741-2524