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

NCT ID: NCT03676426

Last Updated: 2020-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2020-02-20

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.

Conditions

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GI Cancer Thoracic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Patients will be blinded to the comparison being made, but not to the intervention in their arm.

Study Groups

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Web-based AD

Patients will be encouraged to use the web platform for advance care planning/advance directive to document their care preferences..

Group Type EXPERIMENTAL

Web platform for advance care planning/advance directive

Intervention Type OTHER

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.

Paper AD

Patients will be given the standard advance directive and encouraged to complete on their own.

Group Type ACTIVE_COMPARATOR

Standard advance directive

Intervention Type OTHER

Patients receive a paper copy of an advance directive used by social workers at Penn Medicine and are encouraged to complete on their own.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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ourcarewishes.org

Eligibility Criteria

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Inclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ruth & Raymond Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23381535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17942272 (View on PubMed)

Other Identifiers

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829211

Identifier Type: -

Identifier Source: org_study_id

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