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Choice Sets for Advance Directives

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expanded AD Choice
Expanded Life-sustaining Therapy Choice
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Renal Disease focused on measuring end stage renal disease, hemodialysis, dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lourdes-Camden
  • Market Street DaVita
  • Philadelphia 42nd Street DaVita
  • Philadelphia PMC-Lombard DaVita
  • University City DaVita
  • Franklin DaVita
  • PDI Walnut Tower DaVita
  • Callowhill DaVita
  • City Line DaVita
  • South Broad Street
  • Cottman DaVita
  • South Philadelphia DaVita
  • Radnor DaVita
  • Abington DaVita
  • Willow Grove DaVita

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Expanded AD Choice

Standard AD Choice

Expanded Life-sustaining therapy Choice

Standard Life-sustaining Therapy Choice

Arm 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.

"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.

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.

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.

Outcomes

Primary Outcome Measures

advance directive
return of a completed and signed advance directive

Secondary Outcome Measures

Medical Outcomes Study Short Form-12v2
change from baseline in Short Form-12v2 score at 3 months
McGill Quality of Life Questionnaire
change from baseline in McGill Quality of Life Questionnaire at 3 months
Satisfaction with Decision Scale
satisfaction with decision scale measured at baseline after decision to complete an advance directive is made
Decisional Conflict Scale
Decisional Conflict Scale measured immediately after completion of an advance directive
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

Full Information

First Posted
July 16, 2014
Last Updated
January 5, 2016
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02209038
Brief Title
Choice Sets for Advance Directives
Official Title
A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
end stage renal disease, hemodialysis, dialysis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expanded AD Choice
Arm Type
Experimental
Arm 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.
Arm Title
Standard AD Choice
Arm Type
No Intervention
Arm 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.
Arm Title
Expanded Life-sustaining therapy Choice
Arm Type
Experimental
Arm 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.
Arm Title
Standard Life-sustaining Therapy Choice
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Expanded AD Choice
Intervention Type
Behavioral
Intervention Name(s)
Expanded Life-sustaining Therapy Choice
Primary Outcome Measure Information:
Title
advance directive
Description
return of a completed and signed advance directive
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Medical Outcomes Study Short Form-12v2
Description
change from baseline in Short Form-12v2 score at 3 months
Time Frame
baseline and 3 months
Title
McGill Quality of Life Questionnaire
Description
change from baseline in McGill Quality of Life Questionnaire at 3 months
Time Frame
baseline and 3 months
Title
Satisfaction with Decision Scale
Description
satisfaction with decision scale measured at baseline after decision to complete an advance directive is made
Time Frame
baseline
Title
Decisional Conflict Scale
Description
Decisional Conflict Scale measured immediately after completion of an advance directive
Time Frame
up to 4 weeks
Title
no life-sustaining therapy preference specified
Description
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
Time Frame
up to 4 weeks
Other Pre-specified Outcome Measures:
Title
hospital admissions
Description
number of hospital admissions from enrollment to study completion
Time Frame
up to 4 years
Title
ICU admissions
Description
number of ICU admissions from enrollment to study completion
Time Frame
up to 4 years
Title
Hospice admission
Time Frame
up to 4 years
Title
death
Time Frame
up to 4 years
Title
demographics of patients (ineligible) whom already completed a living will
Time Frame
enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D Halpern, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katherine R Courtright, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
Facility Information:
Facility Name
Lourdes-Camden
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Market Street DaVita
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Philadelphia 42nd Street DaVita
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Philadelphia PMC-Lombard DaVita
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University City DaVita
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Franklin DaVita
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
PDI Walnut Tower DaVita
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Callowhill DaVita
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19123
Country
United States
Facility Name
City Line DaVita
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
South Broad Street
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Cottman DaVita
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
South Philadelphia DaVita
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Radnor DaVita
City
Radnor
State/Province
Pennsylvania
ZIP/Postal Code
19087
Country
United States
Facility Name
Abington DaVita
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Willow Grove DaVita
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27510741
Citation
Courtright KR, Madden V, Gabler NB, Cooney E, Kim J, Herbst N, Burgoon L, Whealdon J, Dember LM, Halpern SD. A Randomized Trial of Expanding Choice Sets to Motivate Advance Directive Completion. Med Decis Making. 2017 Jul;37(5):544-554. doi: 10.1177/0272989X16663709. Epub 2016 Aug 10.
Results Reference
derived

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Choice Sets for Advance Directives

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