Back to resultsBlood Pressure (BP) Visit Intensification Study
Primary Purpose
Blood Pressure, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
JNC guideline training
Sponsored by
About this trial
This is an interventional health services research trial for Blood Pressure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
JNC guideline training
Control
Arm Description
Providers will receive current JNC guideline training for treating patients with uncontrolled hypertension.
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.
Outcomes
Primary Outcome Measures
Number of office visits
Increase patient visit intensification for patients with uncontrolled blood pressure (BP) until the BP is under control.
Secondary Outcome Measures
Reduction in Blood Pressure
Providers patient panels will be assessed to understand any changes in blood pressure from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02164331
Brief Title
Blood Pressure (BP) Visit Intensification Study
Official Title
A Multimodal Quality Improvement Intervention Using the JNC Guidelines to Promote Control of Patients' BP in Federally Qualified Health Centers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JNC guideline training
Arm Type
Experimental
Arm Description
Providers will receive current JNC guideline training for treating patients with uncontrolled hypertension.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
JNC guideline training
Intervention Description
Providers will receive a series of trainings on what the JNC guidelines for treating uncontrolled hypertensives are and strategies for meeting those guidelines.
Primary Outcome Measure Information:
Title
Number of office visits
Description
Increase patient visit intensification for patients with uncontrolled blood pressure (BP) until the BP is under control.
Time Frame
Baseline and aniticipated at 1 year
Secondary Outcome Measure Information:
Title
Reduction in Blood Pressure
Description
Providers patient panels will be assessed to understand any changes in blood pressure from baseline
Time Frame
Baseline and anticipated at year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin A Fiscella, MD MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Tobin, PhD
Organizational Affiliation
Clinical Directors Network
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34379277
Citation
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.
Results Reference
derived
PubMed Identifier
26678642
Citation
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.
Results Reference
derived
Learn more about this trial
Blood Pressure (BP) Visit Intensification Study
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