Clinical trial NCT01286311: Tailored Communication to Reduce Cardiovascular Risk
Official title: Tailored Communication to Reduce Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Coronary Artery Disease
Dyslipidemia
Hypertension
Keywords: Health Education
Health Knowledge, Attitudes, Practice
Hypolipidemic Agents/therapeutic use
Patient Education as Topic
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2011-01-31
Enrollment: 464
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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 \<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%.

Primary outcomes:
measure: Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction
timeFrame: 9 months
Secondary outcomes:
measure: Frequency of Clinical Encounters
timeFrame: 9 months
measure: Medication Prescriptions for Dyslipidemia
timeFrame: 9 months
measure: Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed
timeFrame: 9 months
measure: Presence of an Aspirin Prescription
timeFrame: 9 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic
state: Illinois
Study officials:
affiliation: Northwestern University Division of General Internal Medicine, Feinberg School of Medicine and Institute for Healthcare Studies
name: Stephen Persell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Persell SD, Lloyd-Jones DM, Friesema EM, Cooper AJ, Baker DW. Electronic health record-based patient identification and individualized mailed outreach for primary cardiovascular disease prevention: a cluster randomized trial. J Gen Intern Med. 2013 Apr;28(4):554-60. doi: 10.1007/s11606-012-2268-1. Epub 2012 Nov 11.