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

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ClinicalTrials.gov Identifier: NCT01385579
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : January 6, 2014
Last Update Posted : January 6, 2014
Sponsor:
Information provided by (Responsible Party):
Bechara Choucair, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Malignant Neoplasm of Large Intestine
Intervention Other: Care manager outreach
Enrollment 202
Recruitment Details All eligible patients within the health center were randomized to usual care or care manager outreach. Eligibility for randomization was assessed on 12/31/2009. Outreach was conducted from 2/25/2010 through 4/30/2010.
Pre-assignment Details  
Arm/Group Title Usual Care Care Manager Outreach
Hide Arm/Group Description 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. 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
Period Title: Overall Study
Started 98 104
Completed 98 104
Not Completed 0 0
Arm/Group Title Usual Care Care Manager Outreach Total
Hide Arm/Group Description 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. 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 Total of all reporting groups
Overall Number of Baseline Participants 98 104 202
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 104 participants 202 participants
60  (8) 60  (7) 60  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 104 participants 202 participants
Female
58
  59.2%
67
  64.4%
125
  61.9%
Male
40
  40.8%
37
  35.6%
77
  38.1%
1.Primary Outcome
Title Completion of a Colorectal Cancer Screening
Hide Description 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)
Time Frame within 4 months of the initiation of outreach (by June 30, 2010)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Care Manager Outreach
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 98 104
Measure Type: Number
Unit of Measure: participants
5 31
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Care Manager Outreach
Hide Arm/Group Description 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. 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
All-Cause Mortality
Usual Care Care Manager Outreach
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Care Manager Outreach
Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)   0/104 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Usual Care Care Manager Outreach
Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)   0/104 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Muriel Jean-Jacques, Assistant professor
Organization: Northwestern University
Phone: 312-503-9642
Responsible Party: Bechara Choucair, Northwestern University
ClinicalTrials.gov Identifier: NCT01385579     History of Changes
Other Study ID Numbers: STU00015652
First Submitted: June 28, 2011
First Posted: June 30, 2011
Results First Submitted: November 18, 2013
Results First Posted: January 6, 2014
Last Update Posted: January 6, 2014