Trial Outcomes & Findings for Impact of Active Choice on Advance Directive Completion Rates (NCT NCT02289105)
NCT ID: NCT02289105
Last Updated: 2017-01-27
Results Overview
We will analyze the effects of the active choice intervention on rates of completion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1279 participants
Primary outcome timeframe
Baseline - up to 1 year
Results posted on
2017-01-27
Participant Flow
Participant milestones
| Measure |
Mandatory Active Choice
The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form.
|
Control
Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
|
|---|---|---|
|
Overall Study
STARTED
|
642
|
637
|
|
Overall Study
COMPLETED
|
642
|
637
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Active Choice on Advance Directive Completion Rates
Baseline characteristics by cohort
| Measure |
Mandatory Active Choice
n=642 Participants
The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form.
|
Control
n=637 Participants
Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
|
Total
n=1279 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=99 Participants
|
29 years
n=107 Participants
|
29 years
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
446 participants
n=99 Participants
|
472 participants
n=107 Participants
|
918 participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
186 participants
n=99 Participants
|
147 participants
n=107 Participants
|
333 participants
n=206 Participants
|
|
Sex/Gender, Customized
Prefer not to answer or missing
|
10 participants
n=99 Participants
|
18 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
333 participants
n=99 Participants
|
345 participants
n=107 Participants
|
678 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
177 participants
n=99 Participants
|
167 participants
n=107 Participants
|
344 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
51 participants
n=99 Participants
|
41 participants
n=107 Participants
|
92 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed or Other
|
55 participants
n=99 Participants
|
50 participants
n=107 Participants
|
105 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer or missing
|
26 participants
n=99 Participants
|
34 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
642 participants
n=99 Participants
|
637 participants
n=107 Participants
|
1279 participants
n=206 Participants
|
|
Employment Status
Full-time
|
464 participants
n=99 Participants
|
469 participants
n=107 Participants
|
933 participants
n=206 Participants
|
|
Employment Status
Part-time
|
178 participants
n=99 Participants
|
168 participants
n=107 Participants
|
346 participants
n=206 Participants
|
|
Highest level of education
Graduate Degree
|
115 participants
n=99 Participants
|
109 participants
n=107 Participants
|
224 participants
n=206 Participants
|
|
Highest level of education
College Degree
|
304 participants
n=99 Participants
|
298 participants
n=107 Participants
|
602 participants
n=206 Participants
|
|
Highest level of education
Some College
|
136 participants
n=99 Participants
|
133 participants
n=107 Participants
|
269 participants
n=206 Participants
|
|
Highest level of education
High School or Less
|
57 participants
n=99 Participants
|
51 participants
n=107 Participants
|
108 participants
n=206 Participants
|
|
Highest level of education
Missing
|
30 participants
n=99 Participants
|
46 participants
n=107 Participants
|
76 participants
n=206 Participants
|
|
Clinical Degree
No
|
500 participants
n=99 Participants
|
510 participants
n=107 Participants
|
1010 participants
n=206 Participants
|
|
Clinical Degree
Yes
|
142 participants
n=99 Participants
|
127 participants
n=107 Participants
|
269 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline - up to 1 yearWe will analyze the effects of the active choice intervention on rates of completion.
Outcome measures
| Measure |
Mandatory Active Choice
n=642 Participants
The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form.
|
Control
n=637 Participants
Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
|
|---|---|---|
|
Proportion of Participants That Select to Complete an Advance Directive
|
0.35 proportion of participants
Interval 0.31 to 0.39
|
0.20 proportion of participants
Interval 0.17 to 0.24
|
SECONDARY outcome
Timeframe: Baseline - up to 1 yearOutcome measures
| Measure |
Mandatory Active Choice
n=642 Participants
The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form.
|
Control
n=637 Participants
Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
|
|---|---|---|
|
Proportion of Participants Who Already Have ADs
|
.065 proportion of participants
|
.063 proportion of participants
|
SECONDARY outcome
Timeframe: Baseline - up to 1 yearThis measures the proportion of participants who return a signed and printed copy of their AD of those who completed an AD online.
Outcome measures
| Measure |
Mandatory Active Choice
n=642 Participants
The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.
Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form.
|
Control
n=637 Participants
Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
|
|---|---|---|
|
Proportion of Participants Who Return a Signed AD
|
.078 proportion of participants
Interval 0.058 to 0.101
|
.039 proportion of participants
Interval 0.026 to 0.057
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline - up to 1 yearOutcome measures
Outcome data not reported
Adverse Events
Mandatory Active Choice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Dr. Scott Halpern
Fostering Improvement in End-of-Life Decision Science Program
Phone: 215-5739461
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place