End Stage Renal Disease
Conditions
Keywords
end stage renal disease, hemodialysis, dialysis
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.
Interventions
BEHAVIORALExpanded AD Choice
BEHAVIORALExpanded Life-sustaining Therapy Choice
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| advance directive | up to 4 weeks | return of a completed and signed advance directive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Medical Outcomes Study Short Form-12v2 | baseline and 3 months | change from baseline in Short Form-12v2 score at 3 months |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| hospital admissions | up to 4 years | number of hospital admissions from enrollment to study completion |
| ICU admissions | up to 4 years | number of ICU admissions from enrollment to study completion |
| Hospice admission | up to 4 years | — |
| death | up to 4 years | — |
| demographics of patients (ineligible) whom already completed a living will | enrollment | — |
Countries
United States
Outcome results
None listed