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Choice Sets for Advance Directives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02209038
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209038


Locations
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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
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Principal Investigator: Scott D Halpern, MD, PhD University of Pennsylvania
Study Director: Katherine R Courtright, MD University of Pennsylvania
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02209038    
Other Study ID Numbers: 820002
First Posted: August 5, 2014    Key Record Dates
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:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency