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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

March 14, 2001
October 25, 2013
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Complete list of historical versions of study NCT00012636 on ClinicalTrials.gov Archive Site
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Guidelines for Drug Therapy of Hypertension: Closing the Loop
Guidelines for Drug Therapy of Hypertension: Closing the Loop

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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Hypertension
Procedure: Computer generated statements about guideline concordance of drug therapy deliver to clinicians
Arm 1
Intervention: Procedure: Computer generated statements about guideline concordance of drug therapy deliver to clinicians

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
September 2000
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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:

Both
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012636
CPG 97-006
No
Department of Veterans Affairs
Department of Veterans Affairs
Stanford University
Principal Investigator: Mary K. Goldstein, MD MS VA Palo Alto Health Care System
Department of Veterans Affairs
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP