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HypertensionHTNNCT00374452

VISN Collaborative for Improving Hypertension Management With ATHENA-HTN

A study testing ATHENA-CDS-HTN plus Guideline Link and Guideline Link Only in people with Hypertension, run by VA Office of Research and Development at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
ATHENA-CDS-HTN plus Guideline Link and Guideline Link Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
7 sitesUnited States
Study dates
Jan 2007to Mar 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Anyone who does not meet inclusion criteria.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford

    Bedford, Massachusetts, 01730

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130

  • VA Medical Center, Manchester

    Manchester, New Hampshire, 03104

  • VA Connecticut Health Care System (Newington)

    Newington, Connecticut, 06111

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • VA Medical Center, Providence

    Providence, Rhode Island, 02908

  • VA Connecticut Health Care System (West Haven)

    West Haven, Connecticut, 06516

Other trials in United States

About this study

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.

Read the 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.

Conditions
Hypertension
Being tested
ATHENA-CDS-HTN plus Guideline Link, Guideline Link Only
Keywords
hypertension, practice guidelines, quality of health care, decision support systems, evidence-based medicine, medical informatics
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATHENA-CDS-HTN plus Guideline LinkOther

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

  • Guideline Link OnlyOther

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

Study groups in NCT00374452
Study groupRoleWhat they receive
ATHENA-CDS-HTN plus Guideline LinkExperimentalATHENA-CDS-HTN plus Guideline Link. ATHENA-CDS-HTN display on the cover sheet of electronic health record, plus link to the guidelines
Receives: Other: ATHENA-CDS-HTN plus Guideline Link
Guideline Link OnlyOtherGuideline 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
Receives: Other: Guideline Link Only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to one year after index visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionMay 2010
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00374452
Sponsor's protocol ID
IMV 04-062
Acronym
HTN
Status last verified
Mar 2018
First submitted
8 Sep 2006
Last updated
29 Mar 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • Martins SB, Lai S, Tu S, Shankar R, Hastings SN, Hoffman BB, Dipilla N, Goldstein MK. Offline testing of the ATHENA Hypertension decision support system knowledge base to improve the accuracy of recommendations. AMIA Annu Symp Proc. 2006;2006:539-43.

    PubMed 17238399
  • Chan AS, Shankar RD, Coleman RW, Matins SB, Hoffman BB, Goldstein MK. Leveraging point-of-care clinician feedback to study barriers to guideline adherence. AMIA Annu Symp Proc. 2005;2005:915.

    PubMed 16779202
  • Trafton J, Martins S, Michel M, Lewis E, Wang D, Combs A, Scates N, Tu S, Goldstein MK. Evaluation of the acceptability and usability of a decision support system to encourage safe and effective use of opioid therapy for chronic, noncancer pain by primary care providers. Pain Med. 2010 Apr;11(4):575-85. doi: 10.1111/j.1526-4637.2010.00818.x. Epub 2010 Mar 1.

    PubMed 20202142
  • Michel M, Trafton J, Martins S, Wang D, Tu S, Johnson N, Goldstein MK. Improving Patient Safety Using ATHENA-Decision Support System Technology: The Opioid Therapy for Chronic Pain Experience. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 4: Technology and Medication Safety). Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK43756/

    PubMed 21249951
  • Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK, McCant F, Gentry P, Simel DL, Oddone EZ. Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial. Am Heart J. 2009 Mar;157(3):450-6. doi: 10.1016/j.ahj.2008.11.003. Epub 2009 Jan 10.

    PubMed 19249414
  • Goldstein MK. Using health information technology to improve hypertension management. Curr Hypertens Rep. 2008 Jun;10(3):201-7. doi: 10.1007/s11906-008-0038-6.

    PubMed 18765090
  • Cucciare MA, Ketroser N, Wilbourne P, Midboe AM, Cronkite R, Berg-Smith SM, Chardos J. Teaching motivational interviewing to primary care staff in the Veterans Health Administration. J Gen Intern Med. 2012 Aug;27(8):953-61. doi: 10.1007/s11606-012-2016-6. Epub 2012 Feb 28.

    PubMed 22370769
  • Steinman MA, Goldstein MK. When tight blood pressure control is not for everyone: a new model for performance measurement in hypertension. Jt Comm J Qual Patient Saf. 2010 Apr;36(4):164-72. doi: 10.1016/s1553-7250(10)36028-4.

    PubMed 20402373

Questions about this trial

What is this clinical trial studying?

A study testing ATHENA-CDS-HTN plus Guideline Link and Guideline Link Only in people with Hypertension, run by VA Office of Research and Development at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percentages of Events After Index Visit to Primary Care by Patient (time frame: up to one year after index visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00374452, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.

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