Choice Sets for Advance Directives
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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
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Condition or disease | Intervention/treatment | Phase |
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End Stage Renal Disease | Behavioral: Expanded AD Choice Behavioral: Expanded Life-sustaining Therapy Choice | Not Applicable |
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 |

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:
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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:
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Experimental: Expanded Life-sustaining therapy Choice
For each hypothetical illness state described in the living will: 4 answer choices:
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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:
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- advance directive [ Time Frame: up to 4 weeks ]return of a completed and signed advance directive
- Medical Outcomes Study Short Form-12v2 [ Time Frame: baseline and 3 months ]change from baseline in Short Form-12v2 score at 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
- Satisfaction with Decision Scale [ Time Frame: baseline ]satisfaction with decision scale measured at baseline after decision to complete an advance directive is made
- Decisional Conflict Scale [ Time Frame: up to 4 weeks ]Decisional Conflict Scale measured immediately after completion of an advance directive
- 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
- hospital admissions [ Time Frame: up to 4 years ]number of hospital admissions from enrollment to study completion
- ICU admissions [ Time Frame: up to 4 years ]number of ICU admissions from enrollment to study completion
- Hospice admission [ Time Frame: up to 4 years ]
- death [ Time Frame: up to 4 years ]
- demographics of patients (ineligible) whom already completed a living will [ Time Frame: enrollment ]

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

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
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 |
Principal Investigator: | Scott D Halpern, MD, PhD | University of Pennsylvania | |
Study Director: | Katherine R Courtright, MD | University of Pennsylvania |
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 |
end stage renal disease hemodialysis dialysis |
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |