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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expanded AD Choice | Experimental | "Would you like to complete an advance directive with the assistance of any person(s) you choose?" 4 answer choices:
|
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| Standard AD Choice | No Intervention | "Would you like to complete an advance directive with the assistance of any person(s) you choose?" 2 answer choices:
| |
| Expanded Life-sustaining therapy Choice | Experimental | For each hypothetical illness state described in the living will: 4 answer choices:
|
|
| Standard Life-sustaining Therapy Choice | No Intervention | For each hypothetical illness state described in the living will: 3 answer choices:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expanded AD Choice | Behavioral |
| ||
| Expanded Life-sustaining Therapy Choice |
| Measure | Description | Time Frame |
|---|---|---|
| advance directive | return of a completed and signed advance directive | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Outcomes Study Short Form-12v2 | change from baseline in Short Form-12v2 score at 3 months | baseline and 3 months |
| McGill Quality of Life Questionnaire | change from baseline in McGill Quality of Life Questionnaire at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| hospital admissions | number of hospital admissions from enrollment to study completion | up to 4 years |
| ICU admissions | number of ICU admissions from enrollment to study completion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott D Halpern, MD, PhD | University of Pennsylvania | Principal Investigator |
| Katherine R Courtright, MD | University of Pennsylvania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lourdes-Camden | Camden | New Jersey | 08103 | United States | ||
| Market Street DaVita |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27510741 | Derived | 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. |
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| Behavioral |
|
| baseline and 3 months |
| Satisfaction with Decision Scale | satisfaction with decision scale measured at baseline after decision to complete an advance directive is made | baseline |
| Decisional Conflict Scale | Decisional Conflict Scale measured immediately after completion of an advance directive | up to 4 weeks |
| 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 | up to 4 weeks |
| up to 4 years |
| Hospice admission | up to 4 years |
| death | up to 4 years |
| demographics of patients (ineligible) whom already completed a living will | enrollment |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Philadelphia 42nd Street DaVita | Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia PMC-Lombard DaVita | Philadelphia | Pennsylvania | 19104 | United States |
| University City DaVita | Philadelphia | Pennsylvania | 19104 | United States |
| Franklin DaVita | Philadelphia | Pennsylvania | 19106 | United States |
| PDI Walnut Tower DaVita | Philadelphia | Pennsylvania | 19107 | United States |
| Callowhill DaVita | Philadelphia | Pennsylvania | 19123 | United States |
| City Line DaVita | Philadelphia | Pennsylvania | 19131 | United States |
| South Broad Street | Philadelphia | Pennsylvania | 19146 | United States |
| Cottman DaVita | Philadelphia | Pennsylvania | 19149 | United States |
| South Philadelphia DaVita | Philadelphia | Pennsylvania | United States |
| Radnor DaVita | Radnor | Pennsylvania | 19087 | United States |
| Abington DaVita | Willow Grove | Pennsylvania | 19090 | United States |
| Willow Grove DaVita | Willow Grove | Pennsylvania | 19090 | United States |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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