Enhancing Systems of Care to Improve Hypertension Guideline Implementation

NCT ID: NCT03563872

Last Updated: 2019-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Comparator

Team-based care

Group Type ACTIVE_COMPARATOR

Active Comparator

Intervention Type OTHER

Usual, team-based care

Intervention

Enhanced team-based care

Group Type EXPERIMENTAL

Intervention

Intervention Type OTHER

Enhancements to team-based care include clinical decision support and improved protocols for telehealth prescribing.

Interventions

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Intervention

Enhancements to team-based care include clinical decision support and improved protocols for telehealth prescribing.

Intervention Type OTHER

Active Comparator

Usual, team-based care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Joseph Miller, MD

Senior Staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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13455

Identifier Type: -

Identifier Source: org_study_id

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