Tailored Communication to Reduce Cardiovascular Risk

Hypertension Clinical Trial

Official title:

Tailored Communication to Reduce Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286311
• Other study ID #: Reducing CV Risk
• Secondary ID: K08HS015647
• Status: Completed
• Phase: N/A
• First received: January 27, 2011
• Last updated: January 27, 2015
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia
• Hypertension
• Myocardial Ischemia

Intervention

Behavioral:
• Direct-to-patient tailored cardiovascular risk message system
Patient informational mailings

Locations

Country	Name	City	State
United States	Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction	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	9 months	No
Secondary	Frequency of Clinical Encounters	This will measure the difference in frequency of clinical encounters in the electronic medical record.	9 months	No
Secondary	Medication Prescriptions for Dyslipidemia	This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.	9 months	No
Secondary	Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed	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	No
Secondary	Presence of an Aspirin Prescription	This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.	9 months	No