Tailored Communication to Reduce Cardiovascular Risk

NCT ID: NCT01286311

Last Updated: 2015-02-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesterolemia Coronary Artery Disease Dyslipidemia Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Direct-to-patient tailored cardiovascular risk message system

Intervention Type BEHAVIORAL

Patient informational mailings

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Direct-to-patient tailored cardiovascular risk message system

Patient informational mailings

Intervention Type BEHAVIORAL

Eligibility Criteria

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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%.
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Stephen Persell

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen Persell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Division of General Internal Medicine, Feinberg School of Medicine and Institute for Healthcare Studies

Locations

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Northwestern Medical Faculty Foundation General Internal Medicine Ambulatory Clinic

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23143672 (View on PubMed)

Other Identifiers

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K08HS015647

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

Reducing CV Risk

Identifier Type: -

Identifier Source: org_study_id

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