Promoting Cholesterol Screening

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930149
• Other study ID #: 1PO1HS021141-01-Project 2B
• Status: Completed
• Phase: N/A
• First received: August 23, 2013
• Last updated: September 26, 2014
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Lipid Testing
• Primary Prevention of Cardiovascular Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Heartland Health Outreach	Chicago	Illinois
United States	Near North Health Service Corporation	Chicago	Illinois
United States	North Country Health Care	Flagstaff	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of total cholesterol and HDL cholesterol test or full lipid panel	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	No
Secondary	Statin prescription	Secondary outcome is prescription of a statin as assessed by automated electronic queries of electronic health record.	within 3 months of outreach	No