Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Health Services Research
Condition:	Colorectal Cancer
Interventions:	Other: Mailed invitations for FIT test kits; Other: Mailed invitations for a colonoscopy; Other: Visit Based Care

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Mailed Invitations for FIT Test Kits	Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening. Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care. Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy. Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.
Mailed Invitations for a Colonoscopy	Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening. Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care. Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure. Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.
Visit Based Care	No invitation to complete colorectal cancer screening. Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care. Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.

Participant Flow:   Overall Study

	Mailed Invitations for FIT Test Kits	Mailed Invitations for a Colonoscopy	Visit Based Care
STARTED	1593	479	3898
COMPLETED	648	118	471
NOT COMPLETED	945	361	3427

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Men and women, aged 54 to 64 years, who were uninsured but enrolled in the JPS medical assistance program for the uninsured. Not up-to-date with colorectal cancer screening; no history of colorectal cancer, inflammatory bowel disease, or colorectal polyps.

Reporting Groups

	Description
Mailed Invitations for FIT Test Kits	Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening. Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care. Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy. Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.
Mailed Invitations for a Colonoscopy	Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening. Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care. Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure. Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.
Visit Based Care	No invitation to complete colorectal cancer screening. Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care. Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.
Total	Total of all reporting groups

Baseline Measures

	Mailed Invitations for FIT Test Kits	Mailed Invitations for a Colonoscopy	Visit Based Care	Total
Overall Participants Analyzed; [Units: Participants]	1593	479	3898	5970
Age; [Units: Years]; Mean (Standard Deviation)	59 (3)	59 (3)	59 (3)	59 (3)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	993 62.3%	286 59.7%	2517 64.6%	3796 63.6%
Male	600 37.7%	193 40.3%	1381 35.4%	2174 36.4%
Race/Ethnicity, Customized; [Units: Participants]
White	653	195	1600	2448
Black	370	128	913	1411
Hispanic	445	122	1140	1707
Other	125	34	245	404
Primary Language; [Units: Participants]
English	1322	410	3253	4985
Spanish	271	69	645	985

  Outcome Measures

1. Primary:

Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem. [ Time Frame: 1 year ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT 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.

Results Point of Contact:  

Name/Title: Keith E. Argenbright, MD
Organization: University of Texas Southwestern Medical Center
phone: 817-288-9898
e-mail: keith.argenbright@utsouthwestern.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1725-32.

Responsible Party:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT01191411 History of Changes
Other Study ID Numbers:	STU 012011-152
First Submitted:	August 27, 2010
First Posted:	August 30, 2010
Results First Submitted:	October 13, 2014
Results First Posted:	October 20, 2014
Last Update Posted:	May 23, 2017