N/A N=464 Randomized Single-blind Prevention

Tailored Communication to Reduce Cardiovascular Risk

Hypercholesterolemia · Coronary Artery Disease · Dyslipidemia · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01286311 ↗

Enrolled (actual)

464

Serious AEs

—

Results posted

Feb 2015

Primary outcome: Primary: Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction — 11.0; 11.1 % of patients with major LDL reduction — p=0.99

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Direct-to-patient tailored cardiovascular risk message system (Behavioral)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction	11.0; 11.1	0.99
SECONDARY Frequency of Clinical Encounters	61.9; 56.7	0.27
SECONDARY Medication Prescriptions for Dyslipidemia	11.9; 6.0	0.038 sig
SECONDARY Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed	11.8; 4.7	0.13
SECONDARY Presence of an Aspirin Prescription	3.9; 1.8	0.30

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.

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01286311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.