Promoting Cholesterol Screening

This study is not yet open for participant recruitment.
Verified August 2013 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen Persell, Northwestern University
ClinicalTrials.gov Identifier:
NCT01930149
First received: August 23, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  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 Blind (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 Northwestern University:

Primary Outcome Measures:
  • Completion of total cholesterol and HDL cholesterol test or full lipid panel [ Time Frame: within 3 months of outreach ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Secondary outcome is prescription of a statin as assessed by automated electronic queries of electronic health record.


Estimated Enrollment: 450
Study Start Date: September 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01930149

Contacts
Contact: Tiffany L Brown, MPH 312-503-9068 t-brown@northwestern.edu

Locations
United States, Arizona
North Country Health Care Not yet recruiting
Flagstaff, Arizona, United States, 86004
Contact: Eric Henley, MD       ehenley@northcountryhealthcare.org   
Principal Investigator: Eric Henley, MD         
United States, Illinois
Heartland Health Outreach Not yet recruiting
Chicago, Illinois, United States, 60645
Contact: Stephanie Luther, MD       sluther@heartlandalliance.org   
Principal Investigator: Stephanie Luther, MD         
Near North Health Service Corporation Not yet recruiting
Chicago, Illinois, United States, 60610
Contact: Timothy Long, MD       tlong@nmh.org   
Principal Investigator: Timothy Long, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Stephen D Persell, MD, MPH Northwestern University
  More Information

No publications provided

Responsible Party: Stephen Persell, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01930149     History of Changes
Other Study ID Numbers: 1PO1HS021141-01-Project 2B
Study First Received: August 23, 2013
Last Updated: August 23, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014