Promoting Cholesterol Screening

September 26, 2014 updated by: Stephen Persell, Northwestern University

Reducing Disparities in Primary Prevention of Cardiovascular Disease: Promoting Cholesterol Screening

Cholesterol screening is an important prerequisite for cardiovascular disease (CVD) risk assessment. Cholesterol screening is recommended by the United States Preventive Services Task Force (USPSTF). Since reminder systems have been shown to modestly improve the rates of preventive services, including in safety net settings, we will implement patient-directed reminders to health center patients who meet our eligibility criteria.

The aim of this study is to determine if a mailed outreach message and facilitated ordering of screening lipid tests increases cholesterol screening test completion within 3 months among federally qualified community health center patients who are eligible for screening compared to usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86004
        • North Country Health Care
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Near North Health Service Corporation
      • Chicago, Illinois, United States, 60645
        • Heartland Health Outreach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient at participating health center
  • At least 1 visit to clinic in the prior 12 months
  • No total cholesterol and high-density lipoprotein cholesterol result recorded in the electronic health record in the past 5 years
  • No cholesterol screening order placed within the previous 3 months
  • Men 35-75 years old, or women 45-75 years old who also have one of the following: hypertension, obesity, or current smoking

Exclusion Criteria:

  • Previously diagnosed cardiovascular disease, peripheral arterial disease or diabetes mellitus
  • Statin on active medication list
  • Preferred language other than English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care Control Group
Participants randomized to this arm will receive usual care.
Experimental: Mailed patient outreach intervention
Participants randomized to this arm will receive mailed letter from health center that encourages cholesterol testing and describes the steps necessary to obtain the test at the patient's care site. Clinic staff will facilitate the ordering of tests for patients who may not have an office visit.
Behavioral: Mailed patient outreach intervention
This study's intervention is a mailed outreach letter from the health center that encourages cholesterol testing and describes the steps necessary to obtain the test at the patient's care site. Clinic staff will facilitate the ordering of tests for patients who may not have an office visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of total cholesterol and HDL cholesterol test or full lipid panel
Time Frame: within 3 months of outreach
Primary outcome will be completion of total cholesterol and HDL cholesterol test or a full lipid panel recorded within GE Centricity electronic health record at the patient's clinical site.
within 3 months of outreach

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Statin prescription
Time Frame: within 3 months of outreach
Secondary outcome is prescription of a statin as assessed by automated electronic queries of electronic health record.
within 3 months of outreach

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

August 23, 2013

First Posted (Estimate)

August 28, 2013

Study Record Updates

Last Update Posted (Estimate)

September 29, 2014

Last Update Submitted That Met QC Criteria

September 26, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1PO1HS021141-01-Project 2B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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