Comparison of a Web-based Advance Directive to a Standard Advance Directive

Thoracic Cancer Clinical Trial

Official title:

Comparison of a Web-based Advance Directive to a Standard Advance Directive: Randomized Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676426
• Other study ID #: 829211
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: February 20, 2020

Study information

• Verified date: May 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 20, 2020
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• GI Cancer
• Thoracic Cancer

Intervention

Other:
• Web platform for advance care planning/advance directive
Ourcarewishes (OCW) is a web-based platform to document advance care planning based at Penn. OCW contains more detailed content on preferences and values than a standard advance directive and allows electronic sharing with loved ones and transmission to the Penn EHR.
• Standard advance directive
Patients receive a paper copy of an advance directive used by social workers at Penn Medicine and are encouraged to complete on their own.

Locations

Country	Name	City	State
United States	Ruth & Raymond Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Epub 2007 Oct 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New documentation of advance care planning in the EHR	any new advance directive or advance care planning note, excluding an advance directive that either 1) contains only information on the patient's preferred surrogate decision-makers, or 2) is blank except for personal identifying information.	8 weeks
Secondary	Change in satisfaction with end-of-life plans	Change in mean score on the satisfaction with end-of-life scale, adapted from doi: 10.1377/hlthaff.2012.0895, Canadian Healthcare Evaluation Project (CANHELP) questionnaire. This scale measures satisfaction with end-of-life planning on a 12-60 point scale (if all questions answered, 0 possible if "don't know/refusal" chosen for all 12 questions. Higher scores are considered better.	Initial completed at enrollment, survey sent again at 15 days
Secondary	Acceptability	Mean score on an acceptability scale adapted from DOI: 10.1016/j.pec.2007.08.015. This is a scale that measures advance directive acceptability on a 5-50 point scale. Higher scores represent better outcomes.	Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Secondary	Self reporting sharing with surrogate	Proportion reporting sharing with preferred surrogate	Survey sent at 15 days (reminders 4, 6)Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Secondary	Self reporting completion	Proportion reporting completing some or all of the advance directive	Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Secondary	Qualitative feedback	Comments on what patients liked, did not like, and would change about the advance directive	Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Secondary	Surrogate preferences	Proportion of subjects with new information about their preferred surrogate decision-maker in the chart	8 weeks

External Links

•   Web platform for documenting wishes for care