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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandatory active choice | Experimental | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandatory active choice | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants That Select to Complete an Advance Directive | We will analyze the effects of the active choice intervention on rates of completion. | Baseline - up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Already Have ADs | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Selections on ADs and Declination Forms | Baseline - up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott D Halpern, MD, PhD, | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants That Select to Complete an Advance Directive | We will analyze the effects of the active choice intervention on rates of completion. | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline - up to 1 year |
|
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We did not collect or assess serious adverse events because the study is minimal risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Study population is not ideal - healthy workers may not benefit from AD completion as much as older or seriously ill patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Halpern | Fostering Improvement in End-of-Life Decision Science Program | 215-5739461 | shalpern@exchange.upenn.edu |
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|
| Baseline - up to 1 year |
| BG001 | Control | Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Employment Status | Number | participants |
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| Highest level of education | Number | participants |
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| Clinical Degree | Number | participants |
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Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
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| Secondary | Proportion of Participants Who Already Have ADs | Posted | Number | proportion of participants | Baseline - up to 1 year |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline - up to 1 year |
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| Other Pre-specified | Participant Selections on ADs and Declination Forms | Not Posted | Baseline - up to 1 year | Participants |
| 0 |
| 0 |
| 0 |
| 642 |
| EG001 | Control | Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task. | 0 | 0 | 0 | 637 |
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