Trial Outcomes & Findings for Decision Aid to Technologically Enhance Shared Decision Making (NCT NCT01514786)
NCT ID: NCT01514786
Last Updated: 2017-09-15
Results Overview
Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
570 participants
Primary outcome timeframe
6 months following intervention a chart audit will be conducted to determine if CRCS was completed.
Results posted on
2017-09-15
Participant Flow
Participant milestones
| Measure |
Control
Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
|
Intervention With Colorectal Website
Intervention website includes an interactive component including preferences and risk assessment.
Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
|
|---|---|---|
|
Overall Study
STARTED
|
286
|
284
|
|
Overall Study
COMPLETED
|
286
|
284
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decision Aid to Technologically Enhance Shared Decision Making
Baseline characteristics by cohort
| Measure |
Control
n=286 Participants
Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
|
Intervention With Colorectal Website
n=284 Participants
Intervention website includes an interactive component including preferences and risk assessment.
Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
|
Total
n=570 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
|
|
Age, Categorical
Between 18 and 65 years
|
231 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
471 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
177 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
286 Participants
n=5 Participants
|
284 Participants
n=7 Participants
|
570 Participants
n=5 Participants
|
|
Participants screened for colon cancer
|
111 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months following intervention a chart audit will be conducted to determine if CRCS was completed.Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening.
Outcome measures
| Measure |
Control
n=286 Participants
Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
|
Intervention With Colorectal Website
n=284 Participants
Intervention website includes an interactive component including preferences and risk assessment.
Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
|
|---|---|---|
|
Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits
|
111 participants
|
99 participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention With Colorectal Website
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Control
n=286 participants at risk
Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment.
|
Intervention With Colorectal Website
n=284 participants at risk
Intervention website includes an interactive component including preferences and risk assessment.
Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/286 • During 2 year data collection period
No difference This study involved participants looking at a website and completing questionnaires regarding colon cancer risks and screening. The risks of participating in these activities are no greater than participating in everyday activities. The participant who died after consenting died during knee surgery, totally unrelated to participating in the study. This was the only AE that study staff became aware of during the study period.
|
0.35%
1/284 • Number of events 1 • During 2 year data collection period
No difference This study involved participants looking at a website and completing questionnaires regarding colon cancer risks and screening. The risks of participating in these activities are no greater than participating in everyday activities. The participant who died after consenting died during knee surgery, totally unrelated to participating in the study. This was the only AE that study staff became aware of during the study period.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place