Trial Outcomes & Findings for Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening (NCT NCT00860249)

Results Overview

What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

6 months from initial contact

Results posted on

2011-12-05

Participant Flow

The trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. The trial enrolled patients between March and December 2009.

We used data contained in the clinic's electronic health record to identify eligible patients. All eligible patients were randomly assigned to one of the three study arms.

Participant milestones

Participant milestones
Measure	Usual Care Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.	Behavioral: Letter Only Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.	Behavioral: Letter and Educational DVD Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
Overall Study STARTED	21	18	21
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	21	18	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.	Behavioral: Letter Only Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.	Behavioral: Letter and Educational DVD Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
Overall Study trial was terminated prior to completion	21	18	21

Baseline Characteristics

Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=21 Participants Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.	Behavioral: Letter Only n=18 Participants Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.	Behavioral: Letter and Educational DVD n=21 Participants Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	18 Participants n=7 Participants	21 Participants n=5 Participants	60 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	42 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment United States	21 participants n=5 Participants	18 participants n=7 Participants	21 participants n=5 Participants	60 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months from initial contact

Population: Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.

What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.

This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.

Outcome measures

Outcome data not reported

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Behavioral: Letter Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Behavioral: Letter and Educational DVD

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

Kenzie A. Cameron, PhD, MPH

Northwestern University, Department of General Internal Medicine

Phone: 312-503-3910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place