- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01286311
Tailored Communication to Reduce Cardiovascular Risk
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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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.
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Patient informational mailings
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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
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9 months
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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.
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9 months
|
Collaborators and Investigators
Sponsor
Collaborators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Reducing CV Risk
- K08HS015647 (U.S. AHRQ Grant/Contract)
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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