Trial Outcomes & Findings for Outreach for Patients With Uncompleted Colorectal Cancer Screening Orders (NCT NCT00793455)
NCT ID: NCT00793455
Last Updated: 2011-12-01
Results Overview
We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening.
COMPLETED
NA
628 participants
3 months post randomization
2011-12-01
Participant Flow
This trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. This trial was enrolling patients between October 2008 and May 2009.
We used data contained in the clinic's electronic health record to identify eligible patients. All eligible patients were randomly assigned in equal numbers to either the control or intervention arms. All eligible patients were randomized and assigned to groups until we reached target study size.
Participant milestones
| Measure |
Intervention Group
Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
|
Usual Care Control Group
Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
|
|---|---|---|
|
Overall Study
STARTED
|
314
|
314
|
|
Overall Study
COMPLETED
|
314
|
314
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Outreach for Patients With Uncompleted Colorectal Cancer Screening Orders
Baseline characteristics by cohort
| Measure |
Intervention Group
n=314 Participants
Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
|
Usual Care Control Group
n=314 Participants
Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
|
Total
n=628 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.90 years
STANDARD_DEVIATION 7.1 • n=99 Participants
|
58.03 years
STANDARD_DEVIATION 6.6 • n=107 Participants
|
58.0 years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=99 Participants
|
192 Participants
n=107 Participants
|
389 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
239 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
144 participants
n=99 Participants
|
132 participants
n=107 Participants
|
276 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
79 participants
n=99 Participants
|
77 participants
n=107 Participants
|
156 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 participants
n=99 Participants
|
14 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other/unknown
|
82 participants
n=99 Participants
|
91 participants
n=107 Participants
|
173 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
314 participants
n=99 Participants
|
314 participants
n=107 Participants
|
628 participants
n=206 Participants
|
|
Number of visits in past 2 years
1-2
|
69 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Number of visits in past 2 years
3
|
80 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Number of visits in past 2 years
4
|
54 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Number of visits in past 2 years
>=5
|
111 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
219 Participants
n=206 Participants
|
|
Colorectal Cancer (CRC) screening history
Ever screened
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Colorectal Cancer (CRC) screening history
Never screened
|
292 Participants
n=99 Participants
|
290 Participants
n=107 Participants
|
582 Participants
n=206 Participants
|
|
Insurance Status
Private
|
245 Participants
n=99 Participants
|
236 Participants
n=107 Participants
|
481 Participants
n=206 Participants
|
|
Insurance Status
Medicare
|
56 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Insurance Status
Medicaid
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Insurance Status
Uninsured
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months post randomizationPopulation: Analysis was based on intention to treat.
We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening.
Outcome measures
| Measure |
Usual Care Control Group
n=314 Participants
Usual Care
|
Intervention Group
n=314 Participants
Received Educational Outreach
|
|---|---|---|
|
Colorectal Cancer Screening Completion.
Did not Complete Screening
|
304 participants
|
283 participants
|
|
Colorectal Cancer Screening Completion.
Completed Screening
|
10 participants
|
31 participants
|
SECONDARY outcome
Timeframe: 6 months post randomizationPopulation: Analysis was based on intention to treat.
We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening.
Outcome measures
| Measure |
Usual Care Control Group
n=314 Participants
Usual Care
|
Intervention Group
n=314 Participants
Received Educational Outreach
|
|---|---|---|
|
Colorectal Cancer Screening Completion
Completed Screening
|
38 participants
|
57 participants
|
|
Colorectal Cancer Screening Completion
Did not Complete Screening
|
276 participants
|
257 participants
|
Adverse Events
Intervention Group
Usual Care Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place