Improving Care for Patients With High Blood Pressure

Study Overview
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Brief Summary
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The investigators are conducting a single group intervention study to improve blood pressure control and reduce racial and literacy related disparities among people with hypertension. The intervention includes providing patients with home blood pressure monitors, administering phone-coaching to participants, and improving hypertension care at the participating practices from which patients are enrolled. The investigators will follow the patients for 2 years to determine if blood pressure control improves. In addition, the project will explore genetic factors associated with cardiovascular disease risk and treatment success.

Official Title
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Heart Healthy Lenoir: Improving Care for Patients With High Blood Pressure

Conditions
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Hypertension, Cardiovascular Disease Risk

Intervention / Treatment
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* Behavioral: Complex quality improvement intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women who meet the following inclusion criteria will be eligible for study participation: 18 years or older, Able and willing to give informed consent, A current patient of 1 of the 5 participating practices, Have a current diagnosis of hypertension by their primary care physician or have 3 documented blood pressures above 150/90, Their most recent systolic blood pressure was greater than or equal to 150 at their most recent clinic visit, Receive physician approval to participate in the study. Anyone enrolled in the High Blood Pressure study is eligible to participate in the genomics component of the project. Exclusion Criteria: non-English speaking, current treatment of psychosis, diagnosed with advanced dementia as determined by the clinician, current substance abuse, lack of phone access, history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for > 5 years, estimated creatinine clearance less than 30 ml/min (because hypertension management becomes more complicated at this point), are pregnant.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Complex quality improvement intervention|We are implementing a complex quality improvement intervention that includes changes in practice processes to enhance hypertension care, provision of home blood pressure monitors to patients, and telephone coaching around hypertension self-management.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure | We will measures blood pressure at enrollment and then every 6 months for 24 months. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids | We will measure blood lipids including total cholesterol and HDL over the course of the study to calculate overall cardiovascular risk. | 2 years | 
| General Cardiovascular Disease Risk | We will measure variables (blood pressure, cholesterol, aspirin use, smoking status, and diabetes status) to calculate general cardiovascular disease risk which includes (coronary death, myocardial infarction, coronary insufficiency, angina, ischemic stroke, hemorrhagic stroke, transient ischemic attack, peripheral artery disease, heart failure). (D'Agostino, 2008) | 2 years | 
| Genomic predictors of blood pressure change | A systems approach to developing genomic models integrating clinical and genomic data. | 6-, 12-, 18, and 24-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, genomics