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Completed

NCT Number: NCT03676426

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

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

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Key information

Conditions

GI Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Thoracic Cancer

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruth & Raymond Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Web platform for advance care planning/advance directive

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.

Other names: ourcarewishes.org

Standard advance directive

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.

Primary outcomes

  1. New documentation of advance care planning in the EHR

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Change in satisfaction with end-of-life plans

    Time frame: Initial completed at enrollment, survey sent again at 15 days

    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.

  2. Acceptability

    Time frame: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)

    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.

  3. Self reporting sharing with surrogate

    Time frame: Survey sent at 15 days (reminders 4, 6)Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)

    Proportion reporting sharing with preferred surrogate

  4. Self reporting completion

    Time frame: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)

    Proportion reporting completing some or all of the advance directive

  5. Qualitative feedback

    Time frame: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)

    Comments on what patients liked, did not like, and would change about the advance directive

  6. Surrogate preferences

    Time frame: 8 weeks

    Proportion of subjects with new information about their preferred surrogate decision-maker in the chart

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 18, 2018
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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