Enhancing Systems of Care to Improve Hypertension Guideline Implementation

Not Applicable

Withdrawn

• Conditions: Hypertension
• Interventions: Other: Active Comparator; Other: Intervention

• Registration Number: NCT03563872
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study First Submitted: 2018-06-10
• Study First Submitted QC: 2018-06-10
• Study First Posted: 2018-06-20
• Status Verified: 2019-02
• Study Start: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-25
• Primary Completion: 2021-03
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Comparator	Active Comparator	Team-based care
Intervention	Intervention	Enhanced team-based care

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure	12 months	mean change

Secondary Outcome Measures

Name	Time	Method
Change in systolic blood pressure	6 months	mean change
Therapeutic Intensity	12 months	Calculated therapeutic intensity score
Change in diastolic blood pressure	12 months	mean change
Treatment Congruence	12 months	Proportion of clinical encounters in which treatment is congruent with guidelines

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States