Enhancing Systems of Care to Improve Hypertension Guideline Implementation to Communities With Health Disparities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Henry Ford Health System
- Locations
- 1
- Primary Endpoint
- Change in systolic blood pressure
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Active Comparator
Team-based care
Intervention: Active Comparator (Other)
Intervention
Enhanced team-based care
Intervention: Intervention (Other)
Outcomes
Primary Outcomes
Change in systolic blood pressure
Time Frame: 12 months
mean change
Secondary Outcomes
- Change in systolic blood pressure(6 months)
- Change in diastolic blood pressure(12 months)
- Therapeutic Intensity(12 months)
- Treatment Congruence(12 months)
Investigators
Joseph Miller, MD
Senior Staff
Henry Ford Health System