NCT02164331

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

4.2 years

First QC Date

April 7, 2014

Last Update Submit

July 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of office visits

    Increase patient visit intensification for patients with uncontrolled blood pressure (BP) until the BP is under control.

    Baseline and aniticipated at 1 year

Secondary Outcomes (1)

  • Reduction in Blood Pressure

    Baseline and anticipated at year

Study Arms (2)

JNC guideline training

EXPERIMENTAL

Providers will receive current JNC guideline training for treating patients with uncontrolled hypertension.

Behavioral: JNC guideline training

Control

NO INTERVENTION

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.

Interventions

Providers will receive a series of trainings on what the JNC guidelines for treating uncontrolled hypertensives are and strategies for meeting those guidelines.

JNC guideline training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Fiscella K, He H, Sanders M, Cassells A, Carroll JK, Williams SK, Cornell J, Holder T, Khalida C, Tobin JN. Blood Pressure Visit Intensification in Treatment (BP-Visit) Findings: a Pragmatic Stepped Wedge Cluster Randomized Trial. J Gen Intern Med. 2022 Jan;37(1):32-39. doi: 10.1007/s11606-021-07016-9. Epub 2021 Aug 11.

  • Fiscella K, Ogedegbe G, He H, Carroll J, Cassells A, Sanders M, Khalida C, D'Orazio B, Tobin JN. Blood Pressure Visit Intensification Study in Treatment: Trial design. Am Heart J. 2015 Dec;170(6):1202-10. doi: 10.1016/j.ahj.2015.08.022. Epub 2015 Sep 12.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kevin A Fiscella, MD MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR
  • Jonathan Tobin, PhD

    Clinical Directors Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MPH

Study Record Dates

First Submitted

April 7, 2014

First Posted

June 16, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 31, 2018

Record last verified: 2018-07