Clinical trial NCT02209038: Choice Sets for Advance Directives
Official title: A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: end stage renal disease
hemodialysis
dialysis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This study has been designed as two sequential randomized trials to test two separate expanded choice set interventions, with the second randomization enrollment being contingent on results from the first. All enrolled subjects will be asked if they would like to complete an advance directive and will have been randomized to receive either an expanded answer choice set or a standard answer choice, as described in detail elsewhere. Only those subjects who express a desire to complete an advance directive from both arms will then be randomized again in a stratified fashion to receive either a standard advance directive or one with an expanded choice set for the decisions regarding life-sustaining therapy, as described in detail elsewhere.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Proficient in English
* Chronic hemodialysis for minimum 90 days
* Does not currently have a living will

Exclusion Criteria:

* Blindness
* Cognitive impairment that prohibits subject's provision of informed consent

Primary outcomes:
measure: advance directive
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Medical Outcomes Study Short Form-12v2
timeFrame: baseline and 3 months
measure: McGill Quality of Life Questionnaire
timeFrame: baseline and 3 months
measure: Satisfaction with Decision Scale
timeFrame: baseline
measure: Decisional Conflict Scale
timeFrame: up to 4 weeks
measure: no life-sustaining therapy preference specified
timeFrame: up to 4 weeks
Other outcomes:
measure: hospital admissions
timeFrame: up to 4 years
measure: ICU admissions
timeFrame: up to 4 years
measure: Hospice admission
timeFrame: up to 4 years
measure: death
timeFrame: up to 4 years
measure: demographics of patients (ineligible) whom already completed a living will
timeFrame: enrollment
Locations:
city: Camden
country: United States
facility: Lourdes-Camden
state: New Jersey
city: Philadelphia
country: United States
facility: Market Street DaVita
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia 42nd Street DaVita
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia PMC-Lombard DaVita
state: Pennsylvania
city: Philadelphia
country: United States
facility: University City DaVita
state: Pennsylvania
city: Philadelphia
country: United States
facility: Franklin DaVita
state: Pennsylvania
city: Philadelphia
country: United States
facility: PDI Walnut Tower DaVita
state: Pennsylvania
city: Philadelphia
country: United States
facility: Callowhill DaVita
state: Pennsylvania
city: Philadelphia
country: United States
facility: City Line DaVita
state: Pennsylvania
city: Philadelphia
country: United States
facility: South Broad Street
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cottman DaVita
state: Pennsylvania
city: Philadelphia
country: United States
facility: South Philadelphia DaVita
state: Pennsylvania
city: Radnor
country: United States
facility: Radnor DaVita
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington DaVita
state: Pennsylvania
city: Willow Grove
country: United States
facility: Willow Grove DaVita
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Scott D Halpern, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Katherine R Courtright, MD
role: STUDY_DIRECTOR
References:
citation: 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.