Improving Followup of Abnormal Colon Cancer Screening Tests

Improving Followup of Positive Fecal Occult Blood Tests

The purpose of this study is to determine whether direct mailings to patients with positive fecal occult blood tests can increase rates of performing followup colonoscopy.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Patient mailing

Detailed Description

Screening programs using the fecal occult blood test (FOBT) have demonstrated a significant reduction in colorectal cancer mortality, although only when accompanied by a complete diagnostic evaluation of the colon in the setting of a positive result. 90% of patients with a positive FOBT result have completed a subsequent colonoscopy within Harvard Vanguard Medical Associates. This project will use a pre-post study design to increase the rate of followup colonoscopy in the setting of positive FOBT results. Patients in the intervention group will receive a personalized mailing highlighting their positive result and need for colonoscopy, followed by telephone outreach from a centralized gastroenterology scheduling office. The primary outcome will be the performance of colonoscopy, however we will also perform chart reviews to identify predictors of completing appropriate followup.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Newton, Massachusetts, United States, 02466
      • Harvard Vanguard Medical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with positive fecal occult blood test during 2004, 2005, and 2006; and no colonoscopy following this test result

Exclusion Criteria:

• Patients with active cardiopulmonary disease or limited life expectancy due to severe illness such as malignancy
• Colonoscopy within 5 years prior to positive fecal occult blood test
• Age > 80 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Patients will receive a mailing recommending colonoscopy, followed by a telephone outreach	Behavioral: Patient mailing; Patient will receive a mailing recommending colonoscopy, followed by telephone outreach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Performance of colonoscopy	6 months

Collaborators and Investigators

• Sponsor: Harvard Vanguard Medical Associates
• Collaborators: Brigham and Women's Hospital
• Investigators: Principal Investigator: Thomas D Sequist, MD, MPH, Harvard Vanguard Medical Associates

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: February 14, 2007
• First Submitted That Met QC Criteria: February 14, 2007
• First Posted (Estimate): February 16, 2007

Study Record Updates

• Last Update Posted (Estimate): November 6, 2008
• Last Update Submitted That Met QC Criteria: November 5, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Colorectal cancer; Fecal occult blood test; Abnormal test result; Missed diagnosis; Delayed diagnosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Sequist Colorectal Cancer