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

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

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

Study Overview

• Status: Completed
• Conditions: Thoracic Cancer; GI Cancer
• Intervention / Treatment: Other: Web platform for advance care planning/advance directive; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Ruth & Raymond Perelman Center for Advanced Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Web-based AD; Patients will be encouraged to use the web platform for advance care planning/advance directive to document their care preferences..	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.; Other Names: ourcarewishes.org
Active Comparator: Paper AD; Patients will be given the standard advance directive and encouraged to complete on their own.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
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)
Surrogate preferences	Proportion of subjects with new information about their preferred surrogate decision-maker in the chart	8 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Web platform for documenting wishes for care

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): October 20, 2019
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 829211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No