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Guidelines for Drug Therapy of Hypertension: Multi-Site Implementation

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ClinicalTrials.gov Identifier: NCT00122161
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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

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

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Guidelines for Drug Therapy of Hypertension: Multi-Site Implementation
Actual Study Completion Date : September 2005

Arm Intervention/treatment
Arm 1 Behavioral: ATHENA Decision Support System, An Automated Clinical Decision Support System for Health Care Providers Behavioral: Profiling performance



Primary Outcome Measures :
  1. Primary care clinicians adherence to hypertension guidelines and blood pressure control in their panels of patients.


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122161


Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Mary K. Goldstein, MD MS VA Palo Alto Health Care System, Palo Alto, CA

Additional Information:
Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00122161     History of Changes
Other Study ID Numbers: CPI 99-275
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: October 2007

Keywords provided by VA Office of Research and Development:
Drug therapy
Practice guidelines
Reminder systems
Ambulatory care
Hypertension
Clinical protocols
Quality Assurance, Health Care

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases