Trial Outcomes & Findings for Improving Rates of Repeat Colorectal Cancer Screening (NCT NCT01453894)
NCT ID: NCT01453894
Last Updated: 2014-08-15
Results Overview
This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
450 participants
Primary outcome timeframe
within 6 months of randomization
Results posted on
2014-08-15
Participant Flow
Eligible patients identified by query of electronic health record.
Participant milestones
| Measure |
Reminder and Outreach Intervention
Participants randomized to this arm will receive the Reminder and Outreach intervention.
Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.
|
Usual Care Control Group
Patients assigned to this arm will receive usual care.
|
|---|---|---|
|
Overall Study
STARTED
|
225
|
225
|
|
Overall Study
COMPLETED
|
225
|
225
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Rates of Repeat Colorectal Cancer Screening
Baseline characteristics by cohort
| Measure |
Reminder and Outreach Intervention
n=225 Participants
Participants randomized to this arm will receive the Reminder and Outreach intervention.
Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.
|
Usual Care Control Group
n=225 Participants
Patients assigned to this arm will receive usual care.
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino/Hispanic
|
197 participants
n=5 Participants
|
205 participants
n=7 Participants
|
402 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
28 participants
n=5 Participants
|
20 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
225 participants
n=5 Participants
|
225 participants
n=7 Participants
|
450 participants
n=5 Participants
|
|
Insurance Status
Uninsured
|
174 participants
n=5 Participants
|
172 participants
n=7 Participants
|
346 participants
n=5 Participants
|
|
Insurance Status
Insured
|
51 participants
n=5 Participants
|
53 participants
n=7 Participants
|
104 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 6 months of randomizationThis outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants.
Outcome measures
| Measure |
Reminder and Outreach Intervention
n=225 Participants
Participants randomized to this arm will receive the Reminder and Outreach intervention.
Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.
|
Usual Care Control Group
n=225 Participants
Patients assigned to this arm will receive usual care.
|
|---|---|---|
|
Completion of a Fecal Occult Blood Test (FOBT)
|
185 participants
|
84 participants
|
Adverse Events
Reminder and Outreach Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Control Group
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
David W. Baker, MD, MPH
Northwestern University Feinberg School of Medicine
Phone: 312-503-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place