Choice Sets for Advance Directives
A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives
1 other identifier
interventional
321
1 country
15
Brief Summary
There is a large gap between the care seriously ill patients want and the care they receive. Advance directives (ADs) offer an opportunity for patients to express specific end-of-life preferences to avoid unwanted care. As promising as ADs may be for improving the quality of care near the end of life, rates of AD completion remain low and previous efforts to encourage their completion have had limited success. Principles of behavioral economics, such as the effects of defaults and other framing effects, may offer a novel approach to bridge the gap in end-of-life care. The goal of this study is to test whether the framing effect of expanding choice sets can increase the completion of and specification of choices within advance directives.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2014
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 16, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJanuary 7, 2016
January 1, 2016
1 year
July 16, 2014
January 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
advance directive
return of a completed and signed advance directive
up to 4 weeks
Secondary Outcomes (5)
Medical Outcomes Study Short Form-12v2
baseline and 3 months
McGill Quality of Life Questionnaire
baseline and 3 months
Satisfaction with Decision Scale
baseline
Decisional Conflict Scale
up to 4 weeks
no life-sustaining therapy preference specified
up to 4 weeks
Other Outcomes (5)
hospital admissions
up to 4 years
ICU admissions
up to 4 years
Hospice admission
up to 4 years
- +2 more other outcomes
Study Arms (4)
Expanded AD Choice
EXPERIMENTAL"Would you like to complete an advance directive with the assistance of any person(s) you choose?" 4 answer choices: * Yes, I would like to complete a comprehensive version of an advance directive. * Yes, I would like to complete an expanded version of an advance directive. * Yes, I would like to complete a brief version of an advance directive. * No, I do not wish to complete an advance directive.
Standard AD Choice
NO INTERVENTION"Would you like to complete an advance directive with the assistance of any person(s) you choose?" 2 answer choices: * Yes, I would like to complete an AD. * No, I do not wish to complete an advance directive.
Expanded Life-sustaining therapy Choice
EXPERIMENTALFor each hypothetical illness state described in the living will: 4 answer choices: * No, I would not want life support. * Yes, I would want life support. * I would want life support if my doctor believes it could help, but I want to stop receiving life support if at any time my doctor believes it is only delaying the moment of my death. * I do not wish to specify a preference at this time.
Standard Life-sustaining Therapy Choice
NO INTERVENTIONFor each hypothetical illness state described in the living will: 3 answer choices: * No, I would not want life support. * Yes, I would want life support. * I do not wish to specify a preference at this time.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 or older
- Proficient in English
- Chronic hemodialysis for minimum 90 days
- Does not currently have a living will
You may not qualify if:
- Blindness
- Cognitive impairment that prohibits subject's provision of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Lourdes-Camden
Camden, New Jersey, 08103, United States
Market Street DaVita
Philadelphia, Pennsylvania, 19104, United States
Philadelphia 42nd Street DaVita
Philadelphia, Pennsylvania, 19104, United States
Philadelphia PMC-Lombard DaVita
Philadelphia, Pennsylvania, 19104, United States
University City DaVita
Philadelphia, Pennsylvania, 19104, United States
Franklin DaVita
Philadelphia, Pennsylvania, 19106, United States
PDI Walnut Tower DaVita
Philadelphia, Pennsylvania, 19107, United States
Callowhill DaVita
Philadelphia, Pennsylvania, 19123, United States
City Line DaVita
Philadelphia, Pennsylvania, 19131, United States
South Broad Street
Philadelphia, Pennsylvania, 19146, United States
Cottman DaVita
Philadelphia, Pennsylvania, 19149, United States
South Philadelphia DaVita
Philadelphia, Pennsylvania, United States
Radnor DaVita
Radnor, Pennsylvania, 19087, United States
Abington DaVita
Willow Grove, Pennsylvania, 19090, United States
Willow Grove DaVita
Willow Grove, Pennsylvania, 19090, United States
Related Publications (1)
Courtright KR, Madden V, Gabler NB, Cooney E, Kim J, Herbst N, Burgoon L, Whealdon J, Dember LM, Halpern SD. A Randomized Trial of Expanding Choice Sets to Motivate Advance Directive Completion. Med Decis Making. 2017 Jul;37(5):544-554. doi: 10.1177/0272989X16663709. Epub 2016 Aug 10.
PMID: 27510741DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott D Halpern, MD, PhD
University of Pennsylvania
- STUDY DIRECTOR
Katherine R Courtright, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2014
First Posted
August 5, 2014
Study Start
July 1, 2014
Primary Completion
July 1, 2015
Study Completion
October 1, 2015
Last Updated
January 7, 2016
Record last verified: 2016-01