Tailored Communication to Reduce Cardiovascular Risk

Study Overview
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Brief Summary
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The primary goal of the trial is to test the feasibility and efficacy of a cardiovascular disease quality improvement system that couples EMR-based patient identification with individually tailored patient messages. The study will test the hypothesis that that a tailored patient-directed approach to cardiovascular risk reduction integrated into patients' primary care delivery site will improve control of elevated low-density lipoprotein cholesterol and other card iac risk factors more than routine care alone for patients at intermediate or high risk for cardiovascular disease.

Official Title
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Tailored Communication to Reduce Cardiovascular Risk

Conditions
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Hypercholesterolemia, Coronary Artery Disease, Dyslipidemia, Hypertension

Intervention / Treatment
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* Behavioral: Direct-to-patient tailored cardiovascular risk message system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 to 79 years medication list does not include an active lipid lowering medication the patient does not have a diagnosis in the past medical history, active problem list or past visit encounter of coronary heart disease, heart failure, stroke, diabetes mellitus, or peripheral arterial disease the patient has an enrolled study physician recorded as his/her primary care physician the patient has an LDL cholesterol that meets one or more of the criteria listed below. LDL cholesterol >= 130 mg/dl and estimated Framingham Risk Score 10-20% LDL cholesterol >= 100 mg/dl and estimated Framingham Risk Score >20% LDL cholesterol >= 160 mg/dl and estimated Framingham Risk Score 5% to <10%. Exclusion Criteria: Age <40 or >79 years medication list includes an active lipid lowering medication the patient hase a diagnosis in the past medical history, active problem list or past visit encounter of coronary heart disease, heart failure, stroke, diabetes mellitus, or peripheral arterial disease the patient does not have an enrolled study physician recorded as his/her primary care physician the patient does not have an LDL cholesterol that meets one or more of the criteria listed below. LDL cholesterol >= 130 mg/dl and estimated Framingham Risk Score 10-20% LDL cholesterol >= 100 mg/dl and estimated Framingham Risk Score >20% LDL cholesterol >= 160 mg/dl and estimated Framingham Risk Score 5% to <10%.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct-to-patient tailored cardiovascular risk message system<br>Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message. | Behavioral: Direct-to-patient tailored cardiovascular risk message system<br>* Patient informational mailings<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction | Significant LDL cholesterol reduction at 9 months Definition: Percentage of patients with LDL-C repeated and which is at least 30 mg/dl lower than baseline | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Clinical Encounters | This will measure the difference in frequency of clinical encounters in the electronic medical record. | 9 months | 
| Medication Prescriptions for Dyslipidemia | This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia. | 9 months | 
| Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed | This will measure the percentage of participants who had uncontrolled hypertension at baseline who had an increase in the number of antihypertensive medication drug classes prescribed within 9 months. | 9 months | 
| Presence of an Aspirin Prescription | This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Education, Health Knowledge, Attitudes, Practice, Hypolipidemic Agents/therapeutic use, Patient Education as Topic