Choice Sets for Advance Directives

January 5, 2016 updated by: University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Lourdes-Camden
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Market Street DaVita
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia 42nd Street DaVita
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia PMC-Lombard DaVita
      • Philadelphia, Pennsylvania, United States, 19104
        • University City DaVita
      • Philadelphia, Pennsylvania, United States, 19106
        • Franklin DaVita
      • Philadelphia, Pennsylvania, United States, 19107
        • PDI Walnut Tower DaVita
      • Philadelphia, Pennsylvania, United States, 19123
        • Callowhill DaVita
      • Philadelphia, Pennsylvania, United States, 19131
        • City Line DaVita
      • Philadelphia, Pennsylvania, United States, 19146
        • South Broad Street
      • Philadelphia, Pennsylvania, United States, 19149
        • Cottman DaVita
      • Philadelphia, Pennsylvania, United States
        • South Philadelphia DaVita
      • Radnor, Pennsylvania, United States, 19087
        • Radnor DaVita
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington DaVita
      • Willow Grove, Pennsylvania, United States, 19090
        • Willow Grove DaVita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Expanded AD Choice

"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
No Intervention: Standard AD Choice

"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

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
No Intervention: Standard Life-sustaining Therapy Choice

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?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital admissions
Time Frame: up to 4 years
number of hospital admissions from enrollment to study completion
up to 4 years
ICU admissions
Time Frame: up to 4 years
number of ICU admissions from enrollment to study completion
up to 4 years
Hospice admission
Time Frame: up to 4 years
up to 4 years
death
Time Frame: up to 4 years
up to 4 years
demographics of patients (ineligible) whom already completed a living will
Time Frame: enrollment
enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Scott D Halpern, MD, PhD, University of Pennsylvania
  • Study Director: Katherine R Courtright, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 820002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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