Enhancing Systems of Care to Improve Hypertension Guideline Implementation

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03563872
• Other study ID #: 13455
• Status: Withdrawn
• Phase: N/A
• Start date: February 2019
• Est. completion date: January 2024

Study information

• Verified date: February 2019
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Intervention
Enhancements to team-based care include clinical decision support and improved protocols for telehealth prescribing.
• Active Comparator
Usual, team-based care

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost effectiveness	within trial cost and long-term projected costs compared to QALY	12 months
Primary	Change in systolic blood pressure	mean change	12 months
Secondary	Therapeutic Intensity	Calculated therapeutic intensity score	12 months
Secondary	Change in systolic blood pressure	mean change	6 months
Secondary	Change in diastolic blood pressure	mean change	12 months
Secondary	Treatment Congruence	Proportion of clinical encounters in which treatment is congruent with guidelines	12 months