Tailored Communication to Reduce Cardiovascular Risk

Not Applicable

Completed

• Conditions: Hypertension; Hypercholesterolemia; Coronary Artery Disease; Dyslipidemia
• Interventions: Behavioral: Direct-to-patient tailored cardiovascular risk message system

• Registration Number: NCT01286311
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-31
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2013-05-13
• Status Verified: 2015-01
• Results First Submitted QC: 2015-01-27
• Last Update Submitted: 2015-01-27
• Results First Posted: 2015-02-09
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

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%.

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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%.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct-to-patient tailored cardiovascular risk message system	Direct-to-patient tailored cardiovascular risk message system	Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.

Primary Outcome Measures

Name	Time	Method
Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction	9 months	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

Secondary Outcome Measures

Name	Time	Method
Frequency of Clinical Encounters	9 months	This will measure the difference in frequency of clinical encounters in the electronic medical record.
Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed	9 months	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.
Medication Prescriptions for Dyslipidemia	9 months	This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.
Presence of an Aspirin Prescription	9 months	This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.

Trial Locations

Locations (1)

Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic; 🇺🇸 Chicago, Illinois, United States