VISN Collaborative for Improving Hypertension Management With ATHENA-HTN

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00374452
First received: September 8, 2006
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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 will implement a clinical decision support system for primary care clinicians and will evaluate the implementation by studying the impact on the clinicians' prescribing and their patients' blood pressures, and will also study organizational factors.


Condition Intervention
Hypertension
Behavioral: ATHENA-Hypertension clinical decision support system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: VISN Collaborative for Improving Hypertension Management With ATHENA-HTN

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Primary care clinician (health professional) adherence to guideline-recommended management of hypertension Blood pressures for patients of the primary care clinicians [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    The primary outcome is intensification of therapy for hypertension when the patient's blood pressure is above target. Alternate events that we plan to track include: achieving target BP prior to intensification of therapy; return visits with continued blood pressure above target or blood pressure not measured and no intensification of therapy (undesired outcome). The enrollment number 103 is the number of primary careproviders who started the intervention phase of the trial at their study site.


Secondary Outcome Measures:
  • Primary care clinician use of ATHENA decision support system. Prescribing of thiazide diuretics when appropriate; appropriate return intervals for patients with blood pressure not well controlled. Patient medication adherence per pharmacy refill records. [ Time Frame: 12 months, clinician use of the ATHENA decision support system 6 months ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: January 2007
Study Completion Date: March 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines.
Behavioral: ATHENA-Hypertension clinical decision support system
ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.
No Intervention: Arm 2
Link to JNC7 and to VA-DoD hypertension guidelines

  Hide Detailed Description

Detailed Description:

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 have used hypertension as a model to study the translation of research clinical 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), we developed an innovative clinical decision support system: ATHENA-HTN (hypertension). We have demonstrated that deploying this sophisticated system in VA primary care clinics is feasible and clinicians find the system usable and useful, as shown by their actual extensive use of the system and their response to questionnaire survey. We have also found that the system improved clinician prescribing.

Objective(s):

Our objectives in this QUERI-funded VISN Implementation Collaborative include: (1) implement evidence-based guidelines for hypertension by upgrading the ATHENA knowledge-base (KB) to the most recent guidelines; (2) deploy the 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.

Methods:

In Phase 1 we planned to update the KB and conduct offline testing; to revise the M program that extracts patient data daily from VistA to extract additional data elements; to streamline the system architecture to make it easier to implement in multiple sites; to work with the site-PIs to obtain IRB approval at 5 implementation sites in VISN 1 plus the coordinating site at VA Palo Alto; to improve the user interface design; to identify and resolve issues in implementing new information technology in multiple different VAMCs with different CPRS implementations; to train the site PIs in use of the system; and perform baseline data analysis to inform the randomization. In Phase 2 we plan to recruit primary care providers from the participating 5 medical centers in VISN 1; randomize clinics to ATHENA-HTN intervention or usual care; deploy the system for intervention providers; train intervention providers in use of the system; and conduct a 12-month clinical trial of the system. In Phase 3 we plan to analyze the results of the clinical trial.

Status:

As of November 2010, we are in Phase 3 of the project. We have completed IRB approvals at all five medical centers. We have updated the knowledgebase and have conducted offline testing. Our system has been deployed to all five medical centers. We've developed new code to run the system in a thin client environment. We've also developed HTML for a new graphical interface, automatic blood pressure update for the day of visit, and code for blood pressure write back to VistA. Due to difficulties appointing programmer staff we had to defer plans to program the new user interface (that is now being done in a separate project for future use). Our site principal investigators and project coordinator trained intervention providers at the five medical centers on the use of the system. One medical center completed the use of the ATHENA-HTN system for the training period but did not continue with the intervention period. VA Palo Alto staff worked with staff at each VAMC to validate ATHENA-HTN data at each site. We completed a 6-8 month intervention period for the clinical trial at four of the five medical centers. 103 primary care providers from the five medical centers participated in the trial during the active intervention period at their sites. Our random allocation is at clinic (substation) level. As of May 2011, we have closed the IRB at all 5 medical centers in VISN 1 New England; we are conducting data analyses at VA Palo Alto only. We have completed validating the extracted data, and have computed variables and established subset datasets for specific analyses. We are conducting our primary outcome analyses for whether or not pharmacotherapy for hypertension was intensified. We will also be conducing secondary outcome analyses, as time permits, per detailed written data analysis plan.

Impact:

Our VISN Collaborative study will provide insight into how to upgrade automated guidelines (an important issue in light of rapid changes in clinical knowledge and guidelines) and how to integrate the system with the VA electronic medical record across multiple VAMCs. We will learn about barriers and facilitators for clinician guideline adherence, and the impact of this quality improvement strategy on clinician prescribing and patient blood pressures, to learn how clinical decision support systems can best be implemented to assist clinicians in providing evidence-based care for patients

  Eligibility

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Anyone who does not meet inclusion criteria.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00374452

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
United States, Connecticut
VA Connecticut Health Care System (Newington)
Newington, Connecticut, United States, 06111
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Bedford, Massachusetts, United States, 01730
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, New Hampshire
VA Medical Center, Manchester
Manchester, New Hampshire, United States, 03104
United States, Rhode Island
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Investigators
Principal Investigator: Mary K. Goldstein, MD MS VA Palo Alto Health Care System
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00374452     History of Changes
Other Study ID Numbers: IMV 04-062
Study First Received: September 8, 2006
Last Updated: April 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
hypertension
practice guidelines
quality of health care
decision support systems
evidence-based medicine
medical informatics

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014