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Tailored Communication to Reduce Cardiovascular Risk

Primary Purpose

Hypercholesterolemia, Coronary Artery Disease, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Direct-to-patient tailored cardiovascular risk message system
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring Health Education, Health Knowledge, Attitudes, Practice, Hypolipidemic Agents/therapeutic use, Patient Education as Topic

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

  • Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Direct-to-patient tailored cardiovascular risk message system

Control

Arm Description

Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency of Clinical Encounters
This will measure the difference in frequency of clinical encounters in the electronic medical record.
Medication Prescriptions for Dyslipidemia
This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.
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.
Presence of an Aspirin Prescription
This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.

Full Information

First Posted
January 27, 2011
Last Updated
January 27, 2015
Sponsor
Northwestern University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01286311
Brief Title
Tailored Communication to Reduce Cardiovascular Risk
Official Title
Tailored Communication to Reduce Cardiovascular Risk
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Coronary Artery Disease, Dyslipidemia, Hypertension
Keywords
Health Education, Health Knowledge, Attitudes, Practice, Hypolipidemic Agents/therapeutic use, Patient Education as Topic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
464 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct-to-patient tailored cardiovascular risk message system
Arm Type
Experimental
Arm Description
Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Direct-to-patient tailored cardiovascular risk message system
Intervention Description
Patient informational mailings
Primary Outcome Measure Information:
Title
Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction
Description
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
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Frequency of Clinical Encounters
Description
This will measure the difference in frequency of clinical encounters in the electronic medical record.
Time Frame
9 months
Title
Medication Prescriptions for Dyslipidemia
Description
This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.
Time Frame
9 months
Title
Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed
Description
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.
Time Frame
9 months
Title
Presence of an Aspirin Prescription
Description
This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Persell, MD, MPH
Organizational Affiliation
Northwestern University Division of General Internal Medicine, Feinberg School of Medicine and Institute for Healthcare Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23143672
Citation
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.
Results Reference
derived

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Tailored Communication to Reduce Cardiovascular Risk

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