Trial Outcomes & Findings for A Survey of Patient's Attitudes Towards Consent For Clinical Research In Anesthesiology (NCT NCT01546194)
NCT ID: NCT01546194
Last Updated: 2019-09-16
Results Overview
Subjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree.
Recruitment status
COMPLETED
Target enrollment
200 participants
Primary outcome timeframe
First postoperative day
Results posted on
2019-09-16
Participant Flow
Participant milestones
| Measure |
Morning Consent
Consent process consisting of information only provided on the morning of surgery
|
Phone Call and Morning Consent
Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project
Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
64
|
65
|
|
Overall Study
NOT COMPLETED
|
36
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Survey of Patient's Attitudes Towards Consent For Clinical Research In Anesthesiology
Baseline characteristics by cohort
| Measure |
Morning Consent
n=64 Participants
Consent process consisting of information only provided on the morning of surgery
Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial
|
Phone Call and Morning Consent
n=65 Participants
Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project
Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 10 • n=5 Participants
|
56 years
STANDARD_DEVIATION 11 • n=7 Participants
|
56 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First postoperative daySubjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree.
Outcome measures
| Measure |
Morning Consent
n=64 Participants
Consent process consisting of information only provided on the morning of surgery
|
Phone Call and Morning Consent
n=65 Participants
Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project
Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial
|
|---|---|---|
|
Overall Patient Satisfaction With the Same-day Consent Process-total Number of Questions Answered With a Score of 0 to 10 (on a 11-point Scale From 0=Strongly Disagree to 10=Strongly Agree).
|
9.5 units on a scale
Interval 3.0 to 10.0
|
10 units on a scale
Interval 5.0 to 10.0
|
Adverse Events
Morning Consent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phone Call and Morning Consent
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place