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Completed

NCT Number: NCT01286311

Tailored Communication to Reduce Cardiovascular Risk

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.

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Key information

Conditions

Hypercholesterolemia Adherence Interventions Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Artery Disease Coronary Disease Dyslipidemia Dyslipidemias Health Behavior Health Education Heart Diseases Hyperlipidemias Hypertension Lipid Metabolism Disorders Medication Adherence Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Direct-to-patient tailored cardiovascular risk message system

Behavioral

Patient informational mailings

Primary outcomes

  1. Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction

    Time frame: 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 outcomes

  1. Frequency of Clinical Encounters

    Time frame: 9 months

    This will measure the difference in frequency of clinical encounters in the electronic medical record.

  2. Medication Prescriptions for Dyslipidemia

    Time frame: 9 months

    This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.

  3. Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed

    Time frame: 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.

  4. Presence of an Aspirin Prescription

    Time frame: 9 months

    This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 31, 2011
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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