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VISN Collaborative for Improving Hypertension Management With ATHENA-HTN

VISN Collaborative for Improving Hypertension Management With ATHENA-HTN

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00374452
Acronym
HTN
Enrollment
103
Registered
2006-09-11
Start date
2007-01-31
Completion date
2011-03-31
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, practice guidelines, quality of health care, decision support systems, evidence-based medicine, medical informatics

Brief summary

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.

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 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: In Phase 1 we plan to update the KB and conduct offline testing; to revise the M (formerly known as MUMPS) 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 VA medical centers (VAMC) with different Computerized Patient Record System (CPRS) implementations and different methods of distributing computer access to clinicians; 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. Status: The project has been completed. We completed Institutional Review Board (IRB) approvals at all five medical centers. We updated the knowledge base of computable knowledge regarding hypertension and conducted offline testing. Our system was deployed to all five medical centers. While we were preparing for deployment of the CDS, one site changed from a rich-client environment to a thin-client environment for the medical center computers; we developed new code to run the system in a thin client environment. The previous programming computed recommendations of the CDS based on clinical data available the night before the clinic visit (in order to pre-compute advisories for faster display during clinic); in this project we developed software code to obtain automatic blood pressure updates for the day of visit if these were entered by clinical staff at the time of the visit. VA Palo Alto staff worked with staff at each VAMC to validate clinical data extraction at each site. We developed code for a clinician to select, optionally, for blood pressure write-back to VA VistA so that if clinicians entered to our CDS a blood pressure measurement that they had just taken so they could view updated recommendations based on the repeat blood pressure they would not also have to enter that blood pressure separately to electronic health record. We recruited primary care providers (clinicians) at each of 5 medical centers to participate in the project. One of the 5 medical centers completed the installation of the ATHENA-HTN system, but did not continue with the intervention period, so the intervention included 4 rather than 5 medical centers. Our site-principal investigators and project coordinator trained intervention providers on use of the system by offering short phone calls for training or in-person introduction, and by making the system available for a short period of time for familiarity. Records of patients seen by the clinicians in this training period were excluded from analyses. We completed a 6-8 month intervention period for the clinical trial at the 4 participating medical centers. Our random allocation was at clinic level, where a clinic is a substation of a medical center (station). Before initiating data analyses, we prepared a detailed data analysis plan.

Interventions

OTHERATHENA-CDS-HTN plus Guideline Link

ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.

OTHERGuideline Link Only

Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean Percentages of Events After Index Visit to Primary Care by Patientup to one year after index visitThe 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.

Countries

United States

Participant flow

Pre-assignment details

The study initially involved 5 medical centers with 103 participants across the medical centers. One of the 5 medical centers completed installation of ATHENA-HTN system, but did not continue with the intervention period, so the intervention included 4 medical centers with 82 participants.

Participants by arm

ArmCount
Guideline Link Only
Link to JNC7 and to VA-DoD hypertension guidelines Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines.
30
Guideline Link Only
Link to JNC7 and to VA-DoD hypertension guidelines Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines.
10
ATHENA-CDS-HTN
ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines. ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.
46
ATHENA-CDS-HTN
ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines. ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.
10
Total96

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyChange in job role before intervention01
Overall StudyLeft clinic after intervention started11
Overall StudyLeft clinic before intervention started41
Overall StudyWithdrawal by Subject02

Baseline characteristics

CharacteristicTotalGuideline Link OnlyATHENA-CDS-HTN
Age, Customized
Age >= 18 years
76 Participants30 Participants46 Participants
Region of Enrollment
United States
76 Participants30 Participants46 Participants
Sex/Gender, Customized
Mean percentage male participants per clinic
30.1 percentage of male participants35.5 percentage of male participants24.6 percentage of male participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 310 / 46
serious
Total, serious adverse events
0 / 310 / 46

Outcome results

Primary

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

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.

Time frame: up to one year after index visit

ArmMeasureGroupValue (NUMBER)
Guideline Link OnlyMean Percentages of Events After Index Visit to Primary Care by PatientEvent 125.4 mean percentage of events
Guideline Link OnlyMean Percentages of Events After Index Visit to Primary Care by PatientEvent 259.6 mean percentage of events
Guideline Link OnlyMean Percentages of Events After Index Visit to Primary Care by PatientEvent 316.2 mean percentage of events
ATHENA-CDS-HTNMean Percentages of Events After Index Visit to Primary Care by PatientEvent 130.6 mean percentage of events
ATHENA-CDS-HTNMean Percentages of Events After Index Visit to Primary Care by PatientEvent 255.2 mean percentage of events
ATHENA-CDS-HTNMean Percentages of Events After Index Visit to Primary Care by PatientEvent 313.7 mean percentage of events
Comparison: We compared the mean percentages of events per clinician between study arms, using mixed model regression adjusting for medical center, clinic type (community-based clinic vs not), clinician discipline (MD vs non-MD), presence of pharmacist in the clinic, and mean age of clinician's panels of patients as fixed effects, and clinic as a random effect to account for clustering of clinicians within clinics.p-value: >0.1Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026