Enhancing Systems of Care to Improve Hypertension Guideline Implementation

Study Overview
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Other: Intervention
* Other: Active Comparator


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, team-based, guidelines, implementation