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Clinical Trials/NCT03563872
NCT03563872
Withdrawn
Not Applicable

Enhancing Systems of Care to Improve Hypertension Guideline Implementation to Communities With Health Disparities

Henry Ford Health System1 site in 1 countryFebruary 2019
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Henry Ford Health System
Locations
1
Primary Endpoint
Change in systolic blood pressure
Status
Withdrawn
Last Updated
7 years ago

Overview

Brief Summary

This study is a prospective cluster randomized trial testing a systems-level strategy to implement current American Heart Association hypertension guidelines in African American communities at risk for cardiovascular related health disparities. The trial will take place within an integrated health system serving Detroit and will assess blood pressure control over one year's time.

Detailed Description

The trial will randomize 12 clinics within the Henry Ford Health System to two arms. The first arm will be comparison clinics that continue to use existing team-based strategies for hypertension management. The second arm will be intervention clinics. These clinics will have enhancements to existing team-based hypertension management. The first enhancement is clinical decision support based in the electronic health record. The second enhancement is improved protocols to implement telehealth prescribing that is nurse-led. The trial will enroll participants through an urban emergency department. Participants will be assigned to one of these 12 clinics and continue study activities for 1 year. Clinicians at the clinics will manage blood pressure. Study specific visits will occur at 3, 6, 9, and 12 months. Primary outcome assessment is 12 months.

Registry
clinicaltrials.gov
Start Date
February 2019
End Date
January 2024
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph Miller, MD

Senior Staff

Henry Ford Health System

Eligibility Criteria

Inclusion Criteria

  • Adult (\>18 years) African Americans
  • Lacks established primary care for BP management
  • History of HTN
  • SBP ≥ 140 mmHg

Exclusion Criteria

  • Pregnancy
  • Need for hospitalization from ED
  • Serious comorbid conditions
  • Alcohol or drug dependence
  • Suspected resistant HTN
  • Anticipated poor-adherence to study designated primary care clinic

Outcomes

Primary Outcomes

Change in systolic blood pressure

Time Frame: 12 months

mean change

Secondary Outcomes

  • Change in systolic blood pressure(6 months)
  • Therapeutic Intensity(12 months)
  • Change in diastolic blood pressure(12 months)
  • Treatment Congruence(12 months)

Study Sites (1)

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