Guidelines for Drug Therapy of Hypertension: Multi-Site Implementation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00122161
First received: July 18, 2005
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

Clinical trial of implementation of clinical practice guidelines for managing hypertension in primary care clinics.


Condition Intervention Phase
Hypertension
Behavioral: ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers
Behavioral: Profiling performance
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Guidelines for Drug Therapy of Hypertension: Multi-Site Implementation

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Primary care clinicians adherence to hypertension guidelines and blood pressure control in their panels of patients. [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Completion Date: September 2005
Arms Assigned Interventions
Arm 1 Behavioral: ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers Behavioral: Profiling performance

Detailed Description:

Background:

Hypertension, the most commonly reported medical problem in veterans, is a major risk factor for heart disease and stroke. Lowering blood pressure decreases the risk of these adverse clinical outcomes. Widely promoted evidence-based clinical practice guidelines set target blood pressures for adequate control, yet most hypertensives, including VA patients, do not meet the targets. Guidelines also call for use of specific drugs depending on the patient's pattern of comorbid characteristics; yet, clinicians often prescribe drugs that are not guideline-concordant.

Objectives:

The long term objective of this work is to contribute to the VA's ability to respond flexibly to rapidly evolving medical knowledge by establishing a system guidelines that can be used throughout the VA nationally for implementing multiple different clinical practice. In collaboration with Stanford Medical Informatics we developed an automated decision support system for hypertension management, known as ATHENA DSS built with EON technology for guideline-based decision support. ATHENA DSS incorporates hundreds of knowledge rules to operationalize guidelines for hypertension.

Methods:

ATHENA DSS combines patient information from VistA with an automated knowledge base of hypertension to generate patient-specific recommendations for management of hypertension that are displayed to primary care clinicians in pop-up windows in the VA�s Computerized Patient Record System (CPRS) when the record for appropriate patients is opened on the day of scheduled primary care clinic visits. The ATHENA DSS pop-up provides advice on adequacy of control of blood pressure and specific recommendations for drug therapy of hypertension, a visual display of the patient�s medication history and concurrent blood pressures, evidence supporting the main recommendations, and other information. We deployed the system at three VA medical centers--Durham, San Francisco, and Palo Alto�and conducted a clinician-randomized trial. We logged data on use of the system, monitored comments entered by clinicians, and conducted a questionnaire survey of clinicians. We planned analyses of impact on clinician prescribing and patient blood pressures. We planned preparation for dissemination of the system to additional VA medical centers.

Status:

Project work is ongoing at time of preparing this report. We recently received notice of funding for a VISN collaborative that will use the ATHENA DSS in five medical centers in VISN 1 (New England).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Primary care clinicians at participating study sites. That is physicians, nurse practitioners and physician assistants who have their own panel of patients to whom they provide direct patient care.

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00122161

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
VA Medical Center
San Francisco, California, United States, 94121
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Mary K. Goldstein, MD MS VA Palo Alto Health Care System
  More Information

Additional Information:
Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00122161     History of Changes
Other Study ID Numbers: CPI 99-275
Study First Received: July 18, 2005
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Drug therapy
Practice guidelines
Reminder systems
Ambulatory care
Hypertension
Clinical protocols
Quality Assurance, Health Care

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014