NCT03676426

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

September 7, 2018

Last Update Submit

May 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in satisfaction with end-of-life plans

    Initial completed at enrollment, survey sent again at 15 days

  • Acceptability

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

  • Self reporting sharing with 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

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

  • Qualitative feedback

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

  • +1 more secondary outcomes

Study Arms (2)

Web-based AD

EXPERIMENTAL

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

Paper AD

ACTIVE COMPARATOR

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

Other: Standard advance directive

Interventions

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.

Also known as: ourcarewishes.org
Web-based AD

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

Paper AD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruth & Raymond Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related 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.

    PMID: 23381535BACKGROUND
  • 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.

    PMID: 17942272BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Advance Care PlanningAdvance Directives

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services AdministrationJurisprudenceSocial Control, FormalHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Patients will be blinded to the comparison being made, but not to the intervention in their arm.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 18, 2018

Study Start

October 15, 2018

Primary Completion

October 20, 2019

Study Completion

February 20, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations