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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01385579
• Collaborator: (none)
• Enrollment: 202
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 40.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Neoplasm of Large Intestine	Other: Care manager outreach	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 202 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Completion of a Colorectal Cancer Screening [within 4 months of the initiation of outreach (by June 30, 2010)]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Bechara Choucair, Adjunct Associate Professor in Family and Community Medicine, Northwestern University
• ClinicalTrials.gov Identifier: NCT01385579
• Other Study ID Numbers: STU00015652
• First Posted: Jun 30, 2011
• Last Update Posted: Jan 6, 2014
• Last Verified: Nov 1, 2013

• Keywords provided by Bechara Choucair, Adjunct Associate Professor in Family and Community Medicine, Northwestern University: colorectal cancer screening; fecal occult blood testing (FOBT); vulnerable populations; community health center
• Additional relevant MeSH terms: Colorectal Neoplasms; Neoplasms

Study Results

Participant Flow

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.

Arm/Group Title	Usual Care	Care Manager Outreach
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

Baseline Characteristics

Arm/Group Title	Usual Care	Care Manager Outreach	Total
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 Participants	98	104	202
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (8)	60 (7)	60 (8)
Sex: Female, Male (Count of Participants)
Female	58 59.2%	67 64.4%	125 61.9%
Male	40 40.8%	37 35.6%	77 38.1%

Outcome Measures

1. Primary Outcome

Title	Completion of a Colorectal Cancer Screening
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Care Manager Outreach
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
Measure Participants	98	104
Number [participants]	5 5.1%	31 29.8%

Adverse Events

Arm/Group Title	Usual Care		Care Manager Outreach
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Usual Care		Care Manager Outreach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/104 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		Care Manager Outreach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/104 (0%)

Limitations/Caveats

Single site study

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.