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临床试验/NCT00374452
NCT00374452已完成不适用

VISN Collaborative for Improving Hypertension Management With ATHENA-HTN

VA Office of Research and Development14 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2007年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
14
主要终点
Mean Percentages of Events After Index Visit to Primary Care by Patient

研究概览

简要总结

This project is a VA HSR&D-funded Quality Enhancement Research Initiative (QUERI) project to translate into practice evidence about clinical management of primary hypertension. The project aims to contribute to quality improvement of care for patients with primary hypertension. The project implemented a clinical decision support (CDS) system for primary care clinicians and evaluated the implementation by studying the following: impact on the clinicians' prescribing and their patients' blood pressures; the clinician satisfaction with the CDS; and organizational factors in the implementation.

详细描述

Background / Rationale:

Despite the existence of evidence-based guidelines, there is a gap between evidence-based recommended best medical practice and actual practice. In previous work, we used hypertension as a model to study the translation of research regarding clinical blood pressure targets and drug choice into primary care practice through computer-based implementation of clinical practice guidelines. In collaboration with experts in guideline-automation at Stanford Center for Biomedical Informatics Research (BMIR) (formerly known as Stanford Medical Informatics, SMI), we developed an innovative clinical decision support system: ATHENA-CDS-HTN (hypertension) also known as ATHENA-HTN. ATHENA-HTN is a knowledge-based CDS that uses knowledge bases (KBs) of clinical knowledge of hypertension encoded into computable formats. Clinical data from an electronic health records system is processed with the knowledge in the KB by an execution engine (also known as a guideline interpreter) that generates patient-specific outputs with conclusions about the current state of the patient with respect to the guidelines as shown in the patient's electronic health record data and also generates detailed recommendations for next steps in clinical management of the patient's hypertension. The system is designed to take account of multiple data elements in the patients' clinical data including co-morbid diagnoses that are relevant to hypertension and its treatment, other medications currently prescribed, history of adverse drug reactions/events, and selected laboratory values relevant to hypertension and its management. In previous work, we had demonstrated that deploying this CDS system in VA primary care clinics was feasible and that clinicians found the system usable and useful, as shown by their actual extensive use of the system and their response to a questionnaire survey. The current project was funded by the Department of Veterans Affairs Health Services Research and Development (HSR&D), under a special funding initiative for Quality Enhancement Initiative (QUERI) projects designed to improve care for hypertension by collaboration with a Veterans Integrated Service Network (VISN) to implement programs to encourage use of established best-practices for managing hypertension according to evidence-based guidelines available at the time of the study. These studies were known as "VISN Collaboratives". The studies did not involve any new drugs or new uses of established drugs, but rather encouraging use of established drugs recommended in standard evidence-based guidelines for care. The focus of the study was implementation of existing known best practices in managing hypertension, using the CDS as a vehicle to bring information to the point-of-care, with detailed individualized recommendations about patients presented to the primary care provider at the time the provider sees patients in scheduled outpatient primary care clinic visits.

Objective(s):

Our objectives in this VISN Implementation Collaborative included: (1) implement evidence-based guidelines for hypertension in a CDS system by upgrading the ATHENA-HTN knowledge-base (KB) to the most recent guidelines; (2) deploy the CDS system in 5 medical centers within VISN 1 to generate individualized recommendations to primary care clinicians caring for patients in outpatient clinics; (3) evaluate the implementation including the organizational aspects.

Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Must be primary care clinicians (for example, physician or nurse practitioner) at one of the participating VA medical centers. This study is NOT recruiting patients.
  • The primary care clinician must have a panel of patients for whom he or she provides direct care.

排除标准

  • Anyone who does not meet inclusion criteria.

研究组 & 干预措施

ATHENA-CDS-HTN plus Guideline Link

Experimental

ATHENA-CDS-HTN plus Guideline Link. ATHENA-CDS-HTN display on the cover sheet of electronic health record, plus link to the guidelines

干预措施: ATHENA-CDS-HTN plus Guideline Link (Other)

Guideline Link Only

Other

Guideline Link Only. Link to The Seventh Report of the Joint National Committee on Prevention Detection and Treatment of High Blood Pressure (JNC7) and to VA-Department of Defense (DoD) hypertension guidelines

干预措施: Guideline Link Only (Other)

结局指标

主要结局

Mean Percentages of Events After Index Visit to Primary Care by Patient

时间窗: up to one year after index visit

The outcome measure was mean percentages of Events after index visit to primary care by patients. The Events were the first event in the patient record after the index clinic visit for the patient, as follows. Event 1 is intensification of pharmacotherapy for hypertension. Event 2 is patient achieves below-target blood pressure (BP). Event 3 is patient does not achieve below-target BP nor is there intensification of pharmacotherapy for hypertension. Event 4 is patient does not achieve BP target, does not have intensified pharmacotherapy, and does not return for further BP measurements. Each patient was assigned one and only one Event. If a patient has pharmacotherapy intensified and also achieved BP below-target, the patient was assigned to whichever happened first. An initial model fitting all 4 events did not detect a difference by study arm for mean percentage of Event 4; final findings are based on a denominator of Events 1 - 3.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (14)

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