Promoting Cholesterol Screening

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT01930149

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

480

Enrollment

Locations

Arms

Duration (Months)

160

Patients Per Site

26.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Lipid Testing Primary Prevention of Cardiovascular Disease	Behavioral: Mailed patient outreach intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

480 participants

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Completion of total cholesterol and HDL cholesterol test or full lipid panel [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 [within 3 months of outreach]
Secondary outcome is prescription of a statin as assessed by automated electronic queries of electronic health record.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	North Country Health Care	Flagstaff	Arizona	United States	86004
2	Near North Health Service Corporation	Chicago	Illinois	United States	60610
3	Heartland Health Outreach	Chicago	Illinois	United States	60645