Choice Sets for Advance Directives

University of Pennsylvania

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Behavioral: Expanded AD Choice; Behavioral: Expanded Life-sustaining Therapy Choice

Study type: Interventional

Funder types: Other

Identifiers

NCT02209038

820002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 321 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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321 participants in 4 patient groups

Expanded AD Choice

Experimental group

Description:

"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.

Treatment:

Behavioral: Expanded AD Choice

Standard AD Choice

No Intervention group

Description:

"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

Experimental group

Description:

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.

Treatment:

Behavioral: Expanded Life-sustaining Therapy Choice

Standard Life-sustaining Therapy Choice

No Intervention group

Description:

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.