NCT01083940

Brief Summary

In response to the Finding Answers: Disparities Research for Change call for proposals by the Robert Wood Johnson Foundation, we were funded to evaluate the effectiveness of a planned computerized decision support (CDS) intervention aimed at medical providers to overcome clinical inertia when treating blood pressure for hypertensive patients. Based on prior evaluation of the Brigham and Women's Hospital (BWH) adult primary care clinics, we hypothesize that racial and ethnic differences in blood pressure outcomes are largely attributable in differences in providers' aggressiveness in managing patients with hypertension based on patients' race and ethnicity. Within our network of 14 hospital and community-based Brigham and Women's Hospital adult primary care clinics, we aim to determine if the use of CDS to remind to medical providers of poorly controlled hypertensive patients to intensify their hypertension therapy will improve overall rates of blood pressure control and reduce the previously documented racial and ethnic disparities in blood pressure outcomes among our hypertensive patient population. Clinics will first be stratified by location (hospital-based versus community-based) and within each strata will be randomized to either have their providers receive CDS for hypertensive patients whose most recent blood pressure was uncontrolled or to usual care for hypertensive patients. More specifically, we will evaluate our planned intervention by utilizing an 18 month cluster-randomized controlled trial to examine the effectiveness the CDS for intensification of hypertension therapy in: improving levels of blood pressure control, improving provider adherence with recommended changes in drug therapy, and reducing racial/ethnic disparities in the processes of hypertension care and outcomes among our patients receiving primary care for a diagnosis of hypertension.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,600

participants targeted

Target at P75+ for early_phase_1 hypertension

Timeline
Completed

Started Oct 2010

Shorter than P25 for early_phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

March 8, 2010

Last Update Submit

June 22, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of blood pressure control at outcome between study arms

    10/1/2010-10/1/2011

Secondary Outcomes (1)

  • Rate of appropriate intensification of antihypertensive therapy

    10/2010-7/2011

Study Arms (2)

Reminders to providers

EXPERIMENTAL
Other: Computerized reminders on hypertension intensification

usual care

NO INTERVENTION

Interventions

Reminder generated to prompt providers to intensify therapy when patient's blood pressure remains uncontrolled

Reminders to providers

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (\> 20 years) with ICD-9 of hypertension with a minimum of 2 outpatient primary care visits in from 10/2008-10/2009 who receive care for hypertension in the outpatient practices at least once for hypertension from 10/2009-7/2001

You may not qualify if:

  • Pregnancy, age \< 20 years, fewer than two hypertension-related visits from 10/2008-10/2009

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 10, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations