Choice Sets for Advance Directives

• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): University of Pennsylvania

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.

Condition or disease	Intervention/treatment	Phase
End Stage Renal Disease	Behavioral: Expanded AD Choice; Behavioral: Expanded Life-sustaining Therapy Choice	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 321 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives
• Study Start Date: July 2014
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. advance directive [ Time Frame: up to 4 weeks ]
   return of a completed and signed advance directive

Secondary Outcome Measures :

1. Medical Outcomes Study Short Form-12v2 [ Time Frame: baseline and 3 months ]
   change from baseline in Short Form-12v2 score at 3 months
2. McGill Quality of Life Questionnaire [ Time Frame: baseline and 3 months ]
   change from baseline in McGill Quality of Life Questionnaire at 3 months
3. Satisfaction with Decision Scale [ Time Frame: baseline ]
   satisfaction with decision scale measured at baseline after decision to complete an advance directive is made
4. Decisional Conflict Scale [ Time Frame: up to 4 weeks ]
   Decisional Conflict Scale measured immediately after completion of an advance directive
5. 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

Other Outcome Measures:

1. hospital admissions [ Time Frame: up to 4 years ]
   number of hospital admissions from enrollment to study completion
2. ICU admissions [ Time Frame: up to 4 years ]
   number of ICU admissions from enrollment to study completion
3. Hospice admission [ Time Frame: up to 4 years ]
4. death [ Time Frame: up to 4 years ]
5. demographics of patients (ineligible) whom already completed a living will [ Time Frame: enrollment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New Jersey

Lourdes-Camden

Camden, New Jersey, United States, 08103

United States, Pennsylvania

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, 19104

Franklin DaVita

Philadelphia, Pennsylvania, United States, 19106

PDI Walnut Tower DaVita

Philadelphia, Pennsylvania, United States, 19107

Callowhill DaVita

Philadelphia, Pennsylvania, United States, 19123

City Line DaVita

Philadelphia, Pennsylvania, United States, 19131

South Broad Street

Philadelphia, Pennsylvania, United States, 19146

Cottman DaVita

Philadelphia, Pennsylvania, United States, 19149

South Philadelphia DaVita

Philadelphia, Pennsylvania, United States

Radnor DaVita

Radnor, Pennsylvania, United States, 19087

Abington DaVita

Willow Grove, Pennsylvania, United States, 19090

Willow Grove DaVita

Willow Grove, Pennsylvania, United States, 19090

Sponsors and Collaborators

University of Pennsylvania

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02209038 History of Changes
• Other Study ID Numbers: 820002
• First Posted: August 5, 2014
• Last Update Posted: January 7, 2016
• Last Verified: January 2016

Keywords provided by University of Pennsylvania:

end stage renal disease; hemodialysis; dialysis

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency