Boosting Primary Care Awareness and Treatment of Childhood Hypertension

NCT ID: NCT03783650

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-07-14

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.)

Conditions

Pediatric Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

QIC with PCP and without subspecialist

Intervention Type: BEHAVIORAL

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).

QIC with Subspecialist

Intervention Type: BEHAVIORAL

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).

Hub and Spoke co-management

Intervention Type: BEHAVIORAL

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.

Sustainability of changes

Intervention Type: BEHAVIORAL

Practices will sustain their changes, illustrating the durability of these system changes even after QIC completion and without central feedback and regular meetings.

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

Group Type: ACTIVE_COMPARATOR

Control condition

Intervention Type: BEHAVIORAL

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.

QIC with PCP and without subspecialist

Intervention Type: BEHAVIORAL

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).

QIC with Subspecialist

Intervention Type: BEHAVIORAL

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).

Hub and Spoke co-management

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Rinke

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael L Rinke, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine and The Children's Hospital at Montefiore

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

References

Heo M, Rea CJ, Brady TM, Bundy DG, Melikam ES, Orringer K, Tarini BA, Giuliano K, Twombley K, Goilav B, Kelly P, Faith MS, Pietrobelli A, Rinke ML. Racial and Ethnic Disparities in Pediatric Counseling on Nutrition, Lifestyle, and Weight: A Secondary Analysis of the BP-CATCH Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2456238. doi: 10.1001/jamanetworkopen.2024.56238.

Reference Type: DERIVED

PMID: 39878982 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34774574 (View on PubMed)

Other Identifiers

R01HS026239

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

2018-9287

Identifier Type: -

Identifier Source: org_study_id