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Tailored Communication to Reduce Cardiovascular Risk

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Northwestern University.
Recruitment status was  Active, not recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Coronary Disease
Dyslipidemias
Hypercholesterolemia
Hypertension
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014