Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population

NCT ID: NCT01385579

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study is to determine if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population.

Detailed Description

Patients ages 50 to 80 who are identified through the electronic health record as not being up to date on colorectal cancer screening are eligible for the study and will be randomly assigned to the intervention or usual care group. Individuals in the intervention group will be mailed a letter informing them that they are due for colorectal cancer screening, educational material regarding colorectal cancer screening, a fecal occult blood testing (FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients assigned to the intervention versus usual care groups who complete a guideline recommended form of colorectal cancer screening within 4 months of the initiation of outreach will be compared.

Conditions

Malignant Neoplasm of Large Intestine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

usual care

Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Care manager outreach

Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit

Group Type: EXPERIMENTAL

Care manager outreach

Intervention Type: OTHER

Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit. Patients who do not respond to the mail outreach received up to 3 attempts at telephone outreach by the care manager.

Interventions

Care manager outreach

Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit. Patients who do not respond to the mail outreach received up to 3 attempts at telephone outreach by the care manager.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Ages 50 to 80 as of 12/31/2009 At least 2 visits to the community health center between 7/1/2008 and 12/31/2009

Exclusion Criteria

Documented fecal occult blood testing (FOBT) within 1 year (between 1/1/2009 and 12/31/2009) Documented sigmoidoscopy within 5 years (between 1/1/2005 and 12/31/2009) Documented colonoscopy within 10 years (between 1/1/2000 and 12/31/2009)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Bechara Choucair

Adjunct Associate Professor in Family and Community Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bechara N Choucair, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University, Feinberg School of Medicine, Department of Family and Community Medicine

Locations

Heartland International Health Center

Chicago, Illinois, United States

Countries

United States

References

Jean-Jacques M, Kaleba EO, Gatta JL, Gracia G, Ryan ER, Choucair BN. Program to improve colorectal cancer screening in a low-income, racially diverse population: a randomized controlled trial. Ann Fam Med. 2012 Sep-Oct;10(5):412-7. doi: 10.1370/afm.1381.

Reference Type: BACKGROUND

PMID: 22966104 (View on PubMed)

Other Identifiers

STU00015652

Identifier Type: -

Identifier Source: org_study_id