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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bechara Choucair, Northwestern University
ClinicalTrials.gov Identifier:
NCT01385579
First received: June 28, 2011
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Malignant Neoplasm of Large Intestine
Other: Care manager outreach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of a Direct-to-Patient Outreach Program to Improve Rates of Colorectal Cancer Screening in a Low Income and Racially Diverse Population

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Completion of a Colorectal Cancer Screening [ Time Frame: within 4 months of the initiation of outreach (by June 30, 2010) ] [ Designated as safety issue: No ]
    Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)


Enrollment: 202
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: 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
Other: 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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385579

Locations
United States, Illinois
Heartland International Health Center
Chicago, Illinois, United States, 60645
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Bechara N Choucair, MD Northwestern University, Feinberg School of Medicine, Department of Family and Community Medicine
  More Information

Publications:
Responsible Party: Bechara Choucair, Adjunct Associate Professor in Family and Community Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01385579     History of Changes
Other Study ID Numbers: STU00015652
Study First Received: June 28, 2011
Results First Received: November 18, 2013
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
colorectal cancer screening
fecal occult blood testing (FOBT)
vulnerable populations
community health center

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 18, 2014