Tailored Communication to Reduce Cardiovascular Risk

January 27, 2015 updated by: Stephen Persell, Northwestern University
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

464

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: 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.
Patient informational mailings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Clinical Encounters
Time Frame: 9 months
This will measure the difference in frequency of clinical encounters in the electronic medical record.
9 months
Medication Prescriptions for Dyslipidemia
Time Frame: 9 months
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
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.
9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stephen Persell, MD, MPH, Northwestern University Division of General Internal Medicine, Feinberg School of Medicine and Institute for Healthcare Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 27, 2011

First Submitted That Met QC Criteria

January 27, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Estimate)

February 9, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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