GI Cancer, Thoracic Cancer
Conditions
Brief summary
This study will compare a web-based advance directive to a standard advance directive.
Detailed description
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.
Interventions
OTHERWeb 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.
OTHERStandard 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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Patients will be blinded to the comparison being made, but not to the intervention in their arm.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New documentation of advance care planning in the EHR | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 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. |
| 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) | Proportion reporting sharing with preferred surrogate |
| Change in satisfaction with end-of-life plans | 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. |
| Qualitative feedback | 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 |
| Surrogate preferences | 8 weeks | Proportion of subjects with new information about their preferred surrogate decision-maker in the chart |
| Self reporting completion | 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 |
Countries
United States
Outcome results
None listed