Clinical trial NCT00122161: Guidelines for Drug Therapy of Hypertension: Multi-Site Implementation
Official title: Guidelines for Drug Therapy of Hypertension: Multi-Site Implementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Drug therapy
Practice guidelines
Reminder systems
Ambulatory care
Hypertension
Clinical protocols
Quality Assurance, Health Care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-07-21
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

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 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:

Primary outcomes:
measure: Primary care clinicians adherence to hypertension guidelines and blood pressure control in their panels of patients.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Mary K. Goldstein, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
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