Choice Sets for Advance Directives
- Conditions
- End Stage Renal Disease
- Registration Number
- NCT02209038
- Lead Sponsor
- University of Pennsylvania
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 321
- Age 18 or older
- Proficient in English
- Chronic hemodialysis for minimum 90 days
- Does not currently have a living will
- Blindness
- Cognitive impairment that prohibits subject's provision of informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method advance directive up to 4 weeks return of a completed and signed advance directive
- Secondary Outcome Measures
Name Time Method Medical Outcomes Study Short Form-12v2 baseline and 3 months change from baseline in Short Form-12v2 score at 3 months
no life-sustaining therapy preference specified up to 4 weeks among all patients who complete an AD, the proportion of subjects who choose not to specify a preference for life-sustaining therapy on at least 1 clinical scenario within the AD
McGill Quality of Life Questionnaire baseline and 3 months change from baseline in McGill Quality of Life Questionnaire at 3 months
Satisfaction with Decision Scale baseline satisfaction with decision scale measured at baseline after decision to complete an advance directive is made
Decisional Conflict Scale up to 4 weeks Decisional Conflict Scale measured immediately after completion of an advance directive
Trial Locations
- Locations (15)
Lourdes-Camden
🇺🇸Camden, New Jersey, United States
Market Street DaVita
🇺🇸Philadelphia, Pennsylvania, United States
Philadelphia 42nd Street DaVita
🇺🇸Philadelphia, Pennsylvania, United States
Philadelphia PMC-Lombard DaVita
🇺🇸Philadelphia, Pennsylvania, United States
University City DaVita
🇺🇸Philadelphia, Pennsylvania, United States
Franklin DaVita
🇺🇸Philadelphia, Pennsylvania, United States
PDI Walnut Tower DaVita
🇺🇸Philadelphia, Pennsylvania, United States
Callowhill DaVita
🇺🇸Philadelphia, Pennsylvania, United States
City Line DaVita
🇺🇸Philadelphia, Pennsylvania, United States
South Broad Street
🇺🇸Philadelphia, Pennsylvania, United States
Scroll for more (5 remaining)Lourdes-Camden🇺🇸Camden, New Jersey, United States