- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01083940
Impact of Computerized Decision Support on Racial/Ethnic Disparities in Hypertension Outcomes
June 22, 2011 updated by: Brigham and Women's Hospital
Evaluating the Impact of Computerized Decision Support on Racial/Ethnic Disparities in Hypertension Outcomes
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
3600
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02120
- Brigham and Women's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy, age < 20 years, fewer than two hypertension-related visits from 10/2008-10/2009
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: usual care
|
|
Experimental: Reminders to providers
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Reminder generated to prompt providers to intensify therapy when patient's blood pressure remains uncontrolled
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of blood pressure control at outcome between study arms
Time Frame: 10/1/2010-10/1/2011
|
10/1/2010-10/1/2011
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of appropriate intensification of antihypertensive therapy
Time Frame: 10/2010-7/2011
|
10/2010-7/2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Anticipated)
October 1, 2011
Study Completion (Anticipated)
October 1, 2011
Study Registration Dates
First Submitted
March 8, 2010
First Submitted That Met QC Criteria
March 8, 2010
First Posted (Estimate)
March 10, 2010
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 22, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 66708
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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