NCT00374452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

December 18, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

September 8, 2006

Results QC Date

October 19, 2017

Last Update Submit

March 2, 2018

Conditions

Keywords

hypertensionpractice guidelinesquality of health caredecision support systemsevidence-based medicinemedical informatics

Outcome Measures

Primary Outcomes (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.

    up to one year after index visit

Study Arms (2)

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

Other: ATHENA-CDS-HTN plus Guideline Link

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

Other: Guideline Link Only

Interventions

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

ATHENA-CDS-HTN plus Guideline Link

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

Guideline Link Only

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

VA Connecticut Health Care System (Newington)

Newington, Connecticut, 06111, United States

Location

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

Edith Nourse Rogers Memorial Veterans Hospital, Bedford

Bedford, Massachusetts, 01730, United States

Location

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

Boston, Massachusetts, 02130, United States

Location

VA Medical Center, Manchester

Manchester, New Hampshire, 03104, United States

Location

VA Medical Center, Providence

Providence, Rhode Island, 02908, United States

Location

Related Publications (8)

  • 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.

  • 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.

  • 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.

  • 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/

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Limitations and Caveats

The study has originally planned to include 5 large medical centers. One of the medical centers dropped out before the intervention started. This lowered the number of clinic sites and of participants (clinicians).

Results Point of Contact

Title
Mary K. Goldstein, MD
Organization
VA Palo Alto Health Care System

Study Officials

  • Mary K. Goldstein, MD MS

    VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

January 1, 2007

Primary Completion

May 1, 2010

Study Completion

March 1, 2011

Last Updated

March 29, 2018

Results First Posted

December 18, 2017

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations