Trial Outcomes & Findings for Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population (NCT NCT01385579)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

202 participants

Primary outcome timeframe

within 4 months of the initiation of outreach (by June 30, 2010)

Results posted on

2014-01-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	98	104
Overall Study COMPLETED	98	104
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=98 Participants 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.	Care Manager Outreach n=104 Participants 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 n=202 Participants Total of all reporting groups
Age Continuous	60 years STANDARD_DEVIATION 8 • n=5 Participants	60 years STANDARD_DEVIATION 7 • n=7 Participants	60 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	67 Participants n=7 Participants	125 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Usual Care n=98 Participants 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.	Care Manager Outreach n=104 Participants 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
Completion of a Colorectal Cancer Screening	5 participants	31 participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Care Manager Outreach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Muriel Jean-Jacques, Assistant professor

Northwestern University

Phone: 312-503-9642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place