Guidelines for Drug Therapy of Hypertension: Closing the Loop

April 6, 2015 updated by: US Department of Veterans Affairs
Hypertension is a major risk factor for heart disease and stroke. Evidence-based guidelines support the use of specific drugs for patients with specific comorbidities to maximize the decrease in cardiovascular risk; yet, many physicians do not follow these guidelines in choosing drug therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Hypertension is a major risk factor for heart disease and stroke. Evidence-based guidelines support the use of specific drugs for patients with specific comorbidities to maximize the decrease in cardiovascular risk; yet, many physicians do not follow these guidelines in choosing drug therapy.

Objectives:

The goal of this project was to evaluate methods of implementing clinical practice guidelines, using hypertension as a model. We hypothesized that providing patient-specific recommendations to clinicians at the time of clinic contact with hypertensive patients would substantially improve guideline concordance of drug therapy without adversely affecting (possibly improving) blood pressure control. Our long-term goal is to develop and evaluate methods of implementing clinical practice guidelines that build on current knowledge about the most effective approaches to changing clinician behavior, and to extend those methods to other cardiovascular diseases.

Methods:

This project, known as ATHENA, included two major components: (1) We conducted a randomized controlled trial of patient-specific recommendations about drug therapy for hypertension, delivered to primary care clinicians at the time of primary care clinic visits. The recommendations were based on VA Hypertension Guidelines. The trial included 36 clinicians and 4500 hypertensive patients enrolled in primary care clinics at VA Palo Alto Health Care System. We compared a general intervention to an individualized intervention. Both the general and the intervention groups of clinicians received extensive guideline education, as part of a VISN-mandated hypertension guideline implementation. Clinicians randomized to the individualized intervention received, in addition, computer-generated patient-specific recommendations about drug therapy of hypertension, delivered to the clinics with the encounter forms for each visit. (2) In the 2nd major component of the study, we collaborated with Stanford Medical Informatics to develop a hypertension decision support system (ATHENA DSS). ATHENA DSS combines detailed patient information from the VA electronic medical record (VistA) with hypertension guideline knowledge based on the VA and JNC 6 hypertension guidelines. A special feature of ATHENA DSS is that the knowledge in the system can be easily browsed and updated by clinician-managers, so that knowledge can be kept up to date with emerging clinical trial findings about best treatments. We developed an infrastructure to implement the system in a pop-up window in the CPRS-GUI in the primary care clinics at VA Palo Alto. We also conducted an offline test of the program logic by comparing the ATHENA DSS recommendations with those made by a physician for 100 randomly selected VA patients.

Status:

In the past year, we have completed the data collection and data analysis for the randomized trial, and testing for ATHENA DSS, and we are preparing manuscripts. A new project evaluating implementation of guidelines with ATHENA DSS at 3 VA medical centers began in October, 2000.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304-1290
        • VA Palo Alto Health Care System, Palo Alto, CA

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects were primary care clinicians, both physicians and nurse practitioners, at a large VA medical center. Patients were not subjects in this study.

Exclusion Criteria:

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Procedure: Computer generated statements about guideline concordance of drug therapy deliver to clinicians

Collaborators and Investigators

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

Sponsor

US Department of Veterans Affairs

Collaborators

Stanford University

Investigators

  • Principal Investigator: Mary K. Goldstein, MD MS, VA Palo Alto Health Care System, Palo Alto, CA

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 Completion (Actual)

September 1, 2000

Study Registration Dates

First Submitted

March 14, 2001

First Submitted That Met QC Criteria

March 15, 2001

First Posted (Estimate)

March 16, 2001

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPG 97-006

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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