Blood Pressure (BP) Visit Intensification Study

July 27, 2018 updated by: Kevin Fiscella, University of Rochester

A Multimodal Quality Improvement Intervention Using the JNC Guidelines to Promote Control of Patients' BP in Federally Qualified Health Centers

Aim 1: The purpose of the study is to implement the Seventh Joint National Committee on the Diagnosis, Prevention and Treatment of Hypertension (JNC VII) recommendation for monthly visits for hypertensive patients with uncontrolled blood pressure (BP) using a theoretically-informed, empirically grounded, multimodal quality improvement (QI) intervention.

Aim 2: To improve BP control and reduce disparity in BP through implementation of monthly visits.

Aim 3: To assess potential mediators and moderators of the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a stepped wedged cluster randomized trial designed to improve management of uncontrolled blood pressure among patients in federally qualified health centers through the auspices of the the Clinical Directors Network Practice-Based Research Network (CDN PBRN).

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Federally Qualified Health Center in the Clinic Directors Network, Practice Champion, Electronic Medical Record System

Exclusion Criteria:

  • Clinicians who have been at the practice less than 6 months, Practices planning to change Electronic Medical Record systems within the next 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JNC guideline training
Providers will receive current JNC guideline training for treating patients with uncontrolled hypertension.
Behavioral: JNC guideline training
Providers will receive a series of trainings on what the JNC guidelines for treating uncontrolled hypertensives are and strategies for meeting those guidelines.
No Intervention: Control
Provider patient panels will be assessed for number of uncontrolled hypertensives before receiving the JNC guidelines training. These baseline characteristics will serve as their control conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of office visits
Time Frame: Baseline and aniticipated at 1 year
Increase patient visit intensification for patients with uncontrolled blood pressure (BP) until the BP is under control.
Baseline and aniticipated at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Blood Pressure
Time Frame: Baseline and anticipated at year
Providers patient panels will be assessed to understand any changes in blood pressure from baseline
Baseline and anticipated at year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Kevin A Fiscella, MD MPH, University of Rochester
  • Principal Investigator: Jonathan Tobin, PhD, Clinical Directors Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R18HL117801 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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