Thoracic Cancer Clinical Trial
Official title:
Comparison of a Web-based Advance Directive to a Standard Advance Directive: Randomized Evaluation
Verified date | May 2020 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare a web-based advance directive to a standard advance directive.
Status | Completed |
Enrollment | 90 |
Est. completion date | February 20, 2020 |
Est. primary completion date | October 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Ruth & Raymond Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
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. — View Citation
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. Epub 2007 Oct 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Surrogate preferences | Proportion of subjects with new information about their preferred surrogate decision-maker in the chart | 8 weeks |
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