Tailored Communication to Reduce Cardiovascular Risk

This study is ongoing, but not recruiting participants.
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

January 27, 2011
September 27, 2012
January 2011
January 2013   (final data collection date for primary outcome measure)
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
Comparative Outcomes: Intervention Compared to Control [ 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
Complete list of historical versions of study NCT01286311 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Tailored Communication to Reduce Cardiovascular Risk
Tailored Communication to Reduce Cardiovascular Risk

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Hypercholesterolemia
  • Coronary Artery Disease
  • Dyslipidemia
  • Hypertension
Behavioral: Direct-to-patient tailored cardiovascular risk message system
Patient informational mailings
  • 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.
    Intervention: Behavioral: Direct-to-patient tailored cardiovascular risk message system
  • No Intervention: Control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
422
January 2013
January 2013   (final data collection date for primary outcome measure)

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%.

Both
40 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01286311
Reducing CV Risk, K08HS015647
Yes
Stephen Persell, Northwestern University
Northwestern University
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Stephen Persell, MD, MPH Northwestern University Division of General Internal Medicine, Feinberg School of Medicine and Institute for Healthcare Studies
Northwestern University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP