Clinical trial NCT03676426: Comparison of a Web-based Advance Directive to a Standard Advance Directive
Official title: Comparison of a Web-based Advance Directive to a Standard Advance Directive: Randomized Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GI Cancer
Thoracic Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will compare a web-based advance directive to a standard advance directive.

Detailed description: Patients with GI and thoracic malignancies will be randomized to either a standard paper advance directive or the web advance directive (Ourcarewishes.org). Patients will be approached in the Cancer Center and provided the AD information to complete on their own. They will complete a survey at enrollment and a follow up survey administered by email. The primary endpoint will be proportion with new documentation in the EHR at 8 weeks. Second endpoints will include the change in satisfaction with end-of-life plans, AD acceptability, self-reported rates of completion, self-reported rate of sharing with their preferred surrogate decision-maker, proportion with new documentation of preferred decision-maker in the chart, and qualitative feedback. Patients in both groups will receive follow up reminder emails encouraging them to complete the advance directive.

Eligibility criteria: Inclusion Criteria (any of the following)

* Pancreatic cancer, any stage except stage 0 (C25),
* NSCLC, stage IIIA or higher (C34),
* SCLC, any stage (C34),
* Colon cancer, stage IIIB or greater (C18),
* Rectal cancer, stage IIB or greater (C21),
* Esophageal cancer (adeno or squamous), any stage (C15),
* Stomach cancer, stage IIB or greater (C16),
* Gallbladder cancer, stage I or greater (C23),
* Cholangiocarcinoma, any stage (C22.1),
* HCC, any stage (no plan for transplant) (C22.0),
* Malignant carcinoid of GI tract, stage IV (C7A.019).

Exclusion criteria:

* Does not have an active patient portal (MyPennMedicine) account,
* Does not use email at least once per month,
* Has already completed a living will,
* Does not speak fluent English,
* Unwilling to be contacted by email,
* Determined to be too ill or inappropriate for participation by patient's oncologist.

Primary outcomes:
measure: New documentation of advance care planning in the EHR
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in satisfaction with end-of-life plans
timeFrame: Initial completed at enrollment, survey sent again at 15 days
measure: Acceptability
timeFrame: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
measure: Self reporting sharing with surrogate
timeFrame: Survey sent at 15 days (reminders 4, 6)Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
measure: Self reporting completion
timeFrame: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
measure: Qualitative feedback
timeFrame: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
measure: Surrogate preferences
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Ruth & Raymond Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
References:
citation: Halpern SD, Loewenstein G, Volpp KG, Cooney E, Vranas K, Quill CM, McKenzie MS, Harhay MO, Gabler NB, Silva T, Arnold R, Angus DC, Bryce C. Default options in advance directives influence how patients set goals for end-of-life care. Health Aff (Millwood). 2013 Feb;32(2):408-17. doi: 10.1377/hlthaff.2012.0895.
citation: Sudore RL, Landefeld CS, Barnes DE, Lindquist K, Williams BA, Brody R, Schillinger D. An advance directive redesigned to meet the literacy level of most adults: a randomized trial. Patient Educ Couns. 2007 Dec;69(1-3):165-95. doi: 10.1016/j.pec.2007.08.015. Epub 2007 Oct 17.