Boosting Primary Care Awareness and Treatment of Childhood Hypertension

NCT03783650 | Terminated

• 2 other identifiers: 2018-9287R01HS026239
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  average 34 months

Secondary Outcomes (12)

• Number of patients without re-measuring of BP twice in clinic via auscultation

  average 34 months

• Number of patients without weight counseling management decisions

  average 34 months

• Number of patients without lifestyle modification counseling management decisions

  average 34 months

• Number of patients without nutrition counseling management decisions

  average 34 months

• Number of patients without repeat BP measurement visits appropriately timed

  average 34 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Behavioral: QIC with PCP and without subspecialist; Behavioral: QIC with Subspecialist; Behavioral: Hub and Spoke co-management; Behavioral: Sustainability of changes

Cohort 2

ACTIVE COMPARATOR

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

Behavioral: Control condition; Behavioral: QIC with PCP and without subspecialist; Behavioral: QIC with Subspecialist; Behavioral: Hub and Spoke co-management

Interventions

Control condition 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.

Cohort 2

QIC with PCP and without subspecialist 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).

Cohort 1; Cohort 2

QIC with Subspecialist 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).

Cohort 1; Cohort 2

Hub and Spoke co-management 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.

Cohort 1; Cohort 2

Sustainability of changes 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 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Non-pediatric practices

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (2)

• 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.

  PMID: 39878982 DERIVED

• 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.

  PMID: 34774574 DERIVED

Study Officials

• Michael L Rinke, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: September 1, 2018
• Primary Completion: July 14, 2020
• Study Completion: July 14, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)