We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Promoting Cholesterol Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01930149
First Posted: August 28, 2013
Last Update Posted: September 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Stephen Persell, Northwestern University
  Purpose

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.


Condition Intervention
Cardiovascular Diseases Lipid Testing Primary Prevention of Cardiovascular Disease Behavioral: Mailed patient outreach intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Disparities in Primary Prevention of Cardiovascular Disease: Promoting Cholesterol Screening

Resource links provided by NLM:


Further study details as provided by Stephen Persell, Northwestern University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 480
Study Start Date: December 2013
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Usual Care Control Group
Participants randomized to this arm will receive usual care.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930149


Locations
United States, Arizona
North Country Health Care
Flagstaff, Arizona, United States, 86004
United States, Illinois
Near North Health Service Corporation
Chicago, Illinois, United States, 60610
Heartland Health Outreach
Chicago, Illinois, United States, 60645
Sponsors and Collaborators
Northwestern University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Stephen D Persell, MD, MPH Northwestern University
  More Information

Responsible Party: Stephen Persell, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01930149     History of Changes
Other Study ID Numbers: 1PO1HS021141-01-Project 2B
First Submitted: August 23, 2013
First Posted: August 28, 2013
Last Update Posted: September 29, 2014
Last Verified: September 2014

Keywords provided by Stephen Persell, Northwestern University:
Cholesterol screening
High cholesterol
Cardiovascular disease
Statin treatment

Additional relevant MeSH terms:
Cardiovascular Diseases