Overview

This trial is active, not recruiting.

Conditions hypercholesterolemia, coronary artery disease, dyslipidemia, hypertension
Treatment direct-to-patient tailored cardiovascular risk message system
Sponsor Northwestern University
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date January 2011
End date January 2013
Trial size 422 participants
Trial identifier NCT01286311, K08HS015647, Reducing CV Risk

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
direct-to-patient tailored cardiovascular risk message system
Patient informational mailings
(No Intervention)

Primary Outcomes

Measure
Comparative Outcomes: Intervention Group LDL reduction Compared to Control Group LDL reduction
time frame: 9 months

Secondary Outcomes

Measure
Frequency of Clinical Encounters
time frame: 9 months
Medication prescriptions for Dyslipidemia
time frame: 9 months
Medications prescribed for hypertension
time frame: 9 months
Presence of an aspirin prescription
time frame: 9 months

Eligibility Criteria

Male or female participants from 40 years up to 79 years old.

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%.

Additional Information

Official title Tailored Communication to Reduce Cardiovascular Risk
Principal investigator Stephen Persell, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Northwestern University.