An interventional study of Mandatory active choice in Advance Directive Completion, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-27.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research
The overall objective of this project is to assess if an active choice intervention can increase advance directive completion rates.
Nearly 70% of Americans express the desire to die at home, and most individuals want to avoid aggressive or futile care. Despite this, more than half of Americans die in a hospital. Advance directives provide the opportunity to provide, in advance, one's wishes for end of life care, however their completion rates are low. The overall objective of this project is to assess if an active choice intervention can increase AD completion rates. Eligible participants for this study will be all new employees of the University of Pennsylvania Health System (UPHS) who need to complete their online employment paperwork via the On Boarding portal. Participants will have an advanced health care planning task programmed as part of their On Boarding online employment paperwork. Upon selection of the task, each participant will be directed a designated Advance Healthcare Planning (AHCP) website. Participants will be randomized into either the active choice or control arm of the study and proceed through steps to complete or not complete an AD according to the decision making process of the given study arm. All participants in both groups will have access to additional online and telephone resources thought the entire study for any questions. Participants in the active choice group will be given directions stating they are required to complete either the advanced directive or the declination form in order to complete their On Boarding process. Participants in the control group will be given directions stating that completion of the AD is optional.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The mandatory active choice group will be presented two forms at the same time. The first form will be a legally valid AD. The second form will be a declination form. Participants in the intervention arm will be required to complete, and submit either of the two forms the task.
Behavioral: Mandatory active choice
Participants in the control group will be presented an AD form only and will be encouraged to complete, and submit the form without having to declare the choice of completing or declining the AD.
the mandatory active choice group, will be presented two forms at the same time. The first form will be a legally valid AD. The second form will be a declination form. Participants in the intervention arm will be required to complete, and submit either of the two forms the task.
Proportion of Participants That Select to Complete an Advance Directive
We will analyze the effects of the active choice intervention on rates of completion.
Time frame: Baseline - up to 1 year
Proportion of Participants Who Already Have ADs
Time frame: Baseline - up to 1 year
Proportion of Participants Who Return a Signed AD
This measures the proportion of participants who return a signed and printed copy of their AD of those who completed an AD online.
Time frame: Baseline - up to 1 year
Participant Selections on ADs and Declination Forms
Time frame: Baseline - up to 1 year
| Milestone | Mandatory Active Choice | Control |
|---|---|---|
| Started | 642 | 637 |
| Completed | 642 | 637 |
| Not completed | 0 | 0 |
We will analyze the effects of the active choice intervention on rates of completion.
| proportion of participants | Mandatory Active Choice | Control |
|---|---|---|
| Proportion of Participants That Select to Complete an Advance Directive | 0.35 (0.31 to 0.39) | 0.20 (0.17 to 0.24) |
| proportion of participants | Mandatory Active Choice | Control |
|---|---|---|
| Proportion of Participants Who Already Have ADs | .065 | .063 |
This measures the proportion of participants who return a signed and printed copy of their AD of those who completed an AD online.
| proportion of participants | Mandatory Active Choice | Control |
|---|---|---|
| Proportion of Participants Who Return a Signed AD | .078 (.058 to .101) | .039 (.026 to .057) |
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mandatory Active Choice | — | — | 0/642 (0%) |
| Control | — | — | 0/637 (0%) |
| Age, Continuous(years) | Mandatory Active Choice | Control | Total |
|---|---|---|---|
| Median | 29 (25 to 39) | 29 (25 to 37) | 29 (25 to 38) |
| Sex/Gender, Customized(participants) | Mandatory Active Choice | Control | Total |
|---|---|---|---|
| Male | 446 | 472 | 918 |
| Female | 186 | 147 | 333 |
| Prefer not to answer or missing | 10 | 18 | 28 |
| Race/Ethnicity, Customized(participants) | Mandatory Active Choice | Control | Total |
|---|---|---|---|
| White | 333 | 345 | 678 |
| Black | 177 | 167 | 344 |
| Asian | 51 | 41 | 92 |
| Mixed or Other | 55 | 50 | 105 |
| Prefer not to answer or missing | 26 | 34 | 60 |
| Region of Enrollment(participants) | Mandatory Active Choice | Control | Total |
|---|---|---|---|
| United States | 642 | 637 | 1279 |
| Employment Status(participants) | Mandatory Active Choice | Control | Total |
|---|---|---|---|
| Full-time | 464 | 469 | 933 |
| Part-time | 178 | 168 | 346 |
| Highest level of education(participants) | Mandatory Active Choice | Control | Total |
|---|---|---|---|
| Graduate Degree | 115 | 109 | 224 |
| College Degree | 304 | 298 | 602 |
| Some College | 136 | 133 | 269 |
| High School or Less | 57 | 51 | 108 |
| Missing | 30 | 46 | 76 |
| Clinical Degree(participants) | Mandatory Active Choice | Control | Total |
|---|---|---|---|
| No | 500 | 510 | 1010 |
| Yes | 142 | 127 | 269 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania