Choice Sets for Advance Directives

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Behavioral: Expanded AD Choice
* Behavioral: Expanded Life-sustaining Therapy Choice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expanded AD Choice<br>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. | Behavioral: Expanded AD Choice<br> <br> |
| No Intervention: Standard AD Choice<br>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. | |
| Experimental: Expanded Life-sustaining therapy Choice<br>For 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. | Behavioral: Expanded Life-sustaining Therapy Choice<br> <br> |
| No Intervention: Standard Life-sustaining Therapy Choice<br>For 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| advance directive | return of a completed and signed advance directive | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Outcomes Study Short Form-12v2 | change from baseline in Short Form-12v2 score at 3 months | baseline and 3 months | 
| McGill Quality of Life Questionnaire | change from baseline in McGill Quality of Life Questionnaire at 3 months | baseline and 3 months | 
| Satisfaction with Decision Scale | satisfaction with decision scale measured at baseline after decision to complete an advance directive is made | baseline | 
| Decisional Conflict Scale | Decisional Conflict Scale measured immediately after completion of an advance directive | up to 4 weeks | 
| no life-sustaining therapy preference specified | 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 | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end stage renal disease, hemodialysis, dialysis