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

Study Overview
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Brief Summary
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This study will compare a web-based advance directive to a standard advance directive.

Detailed Description
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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.

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

Conditions
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GI Cancer, Thoracic Cancer

Intervention / Treatment
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* Other: Web platform for advance care planning/advance directive
* Other: Standard advance directive


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based AD<br>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<br>* 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.<br>* Other names: ourcarewishes.org;|
| Active Comparator: Paper AD<br>Patients will be given the standard advance directive and encouraged to complete on their own. | Other: Standard advance directive<br>* Patients receive a paper copy of an advance directive used by social workers at Penn Medicine and are encouraged to complete on their own.<br>|

What is the study measuring?
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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 |