Enhancing Systems of Care to Improve Hypertension Guideline Implementation

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension
• Intervention / Treatment: Other: Active Comparator; Other: Intervention

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator; Team-based care	Other: Active Comparator; Usual, team-based care
Experimental: Intervention; Enhanced team-based care	Other: Intervention; Enhancements to team-based care include clinical decision support and improved protocols for telehealth prescribing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure	mean change	12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost effectiveness	within trial cost and long-term projected costs compared to QALY	12 months

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: June 10, 2018
• First Submitted That Met QC Criteria: June 10, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: guidelines; hypertension; implementation; team-based
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 13455 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No