Tailored Communication to Reduce Cardiovascular Risk
This study is ongoing, but not recruiting participants.
Sponsor:
Northwestern University
Collaborator:
Information provided by (Responsible Party):
Stephen Persell, Northwestern University
ClinicalTrials.gov Identifier:
NCT01286311
First received: January 27, 2011
Last updated: September 27, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypercholesterolemia Coronary Artery Disease Dyslipidemia Hypertension |
Behavioral: Direct-to-patient tailored cardiovascular risk message system |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Tailored Communication to Reduce Cardiovascular Risk |
Resource links provided by NLM:
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- Comparative Outcomes: Intervention Group LDL reduction Compared to Control Group LDL reduction [ Time Frame: 9 months ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Frequency of Clinical Encounters [ Time Frame: 9 months ] [ Designated as safety issue: No ]This will measure the difference in frequency of clinical encounters in the electronic medical record.
- Medication prescriptions for Dyslipidemia [ Time Frame: 9 months ] [ Designated as safety issue: No ]This will look at whether medications were prescribed for dyslipidemia.
- Medications prescribed for hypertension [ Time Frame: 9 months ] [ Designated as safety issue: No ]This will measure the presence and dose of prescribed medications for hypertension.
- Presence of an aspirin prescription [ Time Frame: 9 months ] [ Designated as safety issue: No ]This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.
| Estimated Enrollment: | 422 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: Direct-to-patient tailored cardiovascular risk message system
Patient informational mailings
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 40 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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%.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286311
Locations
| United States, Illinois | |
| Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic | |
| Chicago, Illinois, United States, 60611 | |
Sponsors and Collaborators
Northwestern University
Investigators
| Principal Investigator: | Stephen Persell, MD, MPH | Northwestern University Division of General Internal Medicine, Feinberg School of Medicine and Institute for Healthcare Studies |
More Information
No publications provided by Northwestern University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stephen Persell, Assistant Professor, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01286311 History of Changes |
| Other Study ID Numbers: | Reducing CV Risk, K08HS015647 |
| Study First Received: | January 27, 2011 |
| Last Updated: | September 27, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
Health Education Health Knowledge, Attitudes, Practice Hypolipidemic Agents/therapeutic use Patient Education as Topic |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Hypercholesterolemia Hypertension Dyslipidemias Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013