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临床试验/NCT03676426
NCT03676426已完成不适用

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

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
New documentation of advance care planning in the EHR

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •(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).

排除标准

  • •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.

研究组 & 干预措施

Paper AD

Active Comparator

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

干预措施: Standard advance directive (Other)

Web-based AD

Experimental

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

干预措施: Web platform for advance care planning/advance directive (Other)

结局指标

主要结局

New documentation of advance care planning in the EHR

时间窗: 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.

次要结局

  • 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))
  • 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))
  • Surrogate preferences(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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