Advance Directive CompletionNCT02289105
Impact of Active Choice on Advance Directive Completion Rates
A study testing Mandatory active choice in people with Advance Directive Completion, run by University of Pennsylvania at 1 site in United States.
Trial summary
The overall objective of this project is to assess if an active choice intervention can increase advance directive completion rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Directive Completion
- What is being tested?
- Mandatory active choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,279 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- All new UPHS employees will be enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Advance Directive Completion
- Being tested
- Mandatory active choice
- Keywords
- Advance Directive, Active Choice, Decision making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandatory active choiceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mandatory active choice |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants That Select to Complete an Advance Directive
We will analyze the effects of the active choice intervention on rates of completion.
Measured: Baseline - up to 1 year
Secondary outcomes (2)
Proportion of Participants Who Already Have ADs
Measured: 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.
Measured: Baseline - up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advance Directive CompletionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,279 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott D Halpern, MD, PhD,, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289105
- Sponsor's protocol ID
- 818456
- Status last verified
- Dec 2016
- First submitted
- 5 Nov 2014
- Last updated
- 27 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Active Choice on Completion Rates of Advanced Directives in New Employees of an Academic University Hospital
- ClinicalTrials.gov ID
- NCT02289105
- Acronym / sponsor ID
- 818456
- Conditions
- Advance Directive Completion
- Keywords
- Advance Directive, Active Choice, Decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,279 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Posted 27 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this project is to assess if an active choice intervention can increase advance directive completion rates.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandatory active choice | Experimental | Behavioral: Mandatory active choiceThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- All new UPHS employees will be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandatory active choicethe 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. | Behavioural | Mandatory active choice |
Primary outcome
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.
2 secondary outcomes
Proportion of Participants Who Already Have ADs
Time frame: Baseline - up to 1 year
Proportion of Participants Who Return a Signed AD
Time frame: Baseline - up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott D Halpern, MD, PhD, principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandatory active choice in people with Advance Directive Completion, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants That Select to Complete an Advance Directive (time frame: Baseline - up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.