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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01930149
Other study ID # 1PO1HS021141-01-Project 2B
Secondary ID
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


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
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