Guidelines for Drug Therapy of Hypertension: Closing the Loop

This study has been completed.
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012636
First received: March 14, 2001
Last updated: October 25, 2013
Last verified: February 2007
  Purpose

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.


Condition Intervention
Hypertension
Procedure: Computer generated statements about guideline concordance of drug therapy deliver to clinicians

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Guidelines for Drug Therapy of Hypertension: Closing the Loop

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 36
Study Completion Date: September 2000
Arms Assigned Interventions
Arm 1 Procedure: Computer generated statements about guideline concordance of drug therapy deliver to clinicians

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.

  Eligibility

Genders Eligible for Study:   Both
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012636

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Mary K. Goldstein, MD MS VA Palo Alto Health Care System
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012636     History of Changes
Other Study ID Numbers: CPG 97-006
Study First Received: March 14, 2001
Last Updated: October 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014