- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02289105
Impact of Active Choice on Advance Directive Completion Rates
December 1, 2016 updated by: University of Pennsylvania
The Impact of Active Choice on Completion Rates of Advanced Directives in New Employees of an Academic University Hospital
The overall objective of this project is to assess if an active choice intervention can increase advance directive completion rates.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
1279
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- New participants of the University of Pennsylvania Health System who have not yet completed their On Boarding process.
- 18 years of age or older
- Have proficiency in reading, writing, and speaking English
Exclusion Criteria:
- All new UPHS employees will be enrolled
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mandatory active choice
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.
|
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.
|
|
No Intervention: Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants That Select to Complete an Advance Directive
Time Frame: Baseline - up to 1 year
|
We will analyze the effects of the active choice intervention on rates of completion.
|
Baseline - up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants Who Already Have ADs
Time Frame: Baseline - up to 1 year
|
Baseline - up to 1 year
|
|
|
Proportion of Participants Who Return a Signed AD
Time Frame: Baseline - up to 1 year
|
This measures the proportion of participants who return a signed and printed copy of their AD of those who completed an AD online.
|
Baseline - up to 1 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Participant Selections on ADs and Declination Forms
Time Frame: Baseline - up to 1 year
|
Baseline - up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Scott D Halpern, MD, PhD,, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
November 5, 2014
First Submitted That Met QC Criteria
November 7, 2014
First Posted (Estimate)
November 13, 2014
Study Record Updates
Last Update Posted (Estimate)
January 27, 2017
Last Update Submitted That Met QC Criteria
December 1, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 818456
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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