Viewing Study NCT00012636



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Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00012636
Status: COMPLETED
Last Update Posted: 2015-04-07
First Post: 2001-03-14

Brief Title: Guidelines for Drug Therapy of Hypertension Closing the Loop
Sponsor: US Department of Veterans Affairs
Organization: VA Office of Research and Development

Study Overview

Official Title: Guidelines for Drug Therapy of Hypertension Closing the Loop
Status: COMPLETED
Status Verified Date: 2007-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None