NCT01930149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 29, 2014

Status Verified

September 1, 2014

Enrollment Period

3 months

First QC Date

August 23, 2013

Last Update Submit

September 26, 2014

Conditions

Cardiovascular DiseasesLipid TestingPrimary Prevention of Cardiovascular Disease

Keywords

Cholesterol screeningHigh cholesterolCardiovascular diseaseStatin treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Statin prescription

    within 3 months of outreach

Study Arms (2)

Mailed patient outreach intervention

EXPERIMENTAL

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

Usual Care Control Group

NO INTERVENTION

Participants randomized to this arm will receive usual care.

Interventions

Mailed patient outreach interventionBEHAVIORAL

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.

Mailed patient outreach intervention

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previously diagnosed cardiovascular disease, peripheral arterial disease or diabetes mellitus
  • Statin on active medication list
  • Preferred language other than English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

North Country Health Care

Flagstaff, Arizona, 86004, United States

Location

Near North Health Service Corporation

Chicago, Illinois, 60610, United States

Location

Heartland Health Outreach

Chicago, Illinois, 60645, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Stephen D Persell, MD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 28, 2013

Study Start

December 1, 2013

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

September 29, 2014

Record last verified: 2014-09

Locations

US(3)