跳至主要内容
临床试验/NCT06090552
NCT06090552招募中不适用

I CAN DO Surgical ACP (Improving Completion, Accuracy, and Dissemination of Surgical Advanced Care Planning) Trial

University of California, San Francisco6 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2025年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
6,000
试验地点
6
主要终点
Number of participants with clinically meaningful Advanced Care Planning

研究概览

简要总结

The goal of the Advanced Care Planning (ACP) study is to encourage patients aged 65 or older who are referred for elective surgery to have advanced care planning.

详细描述

ACP is also a critical way to support older adults in participating actively with clinicians in making real-time, complex medical decisions so that the medical care they receive is aligned with their goals. Our team has designed and tested a theory-based, interactive ACP patient-facing technology solution (PREPARE) based on the new ACP paradigm of preparing people for communication and medical decision-making. The study team hypothesizes that by including PREPARE into the EHR-centric pre-surgery workflow for older adults and including automated patient reminders, easy-to-read materials, and, in Arm 3, directed support from a healthcare navigator (HCN), they can empower patients and surgical teams to engage in ACP discussions. They also hypothesize that ACP documentation will increase more with increasing resource intensity (i.e., Arm 3 more than Arm 2 more than Arm 1).

Participants will be randomized to Arms: (1) Letter about ACP, PREPARE advanced directive (AD), PREPARE website; (2) Letter, advanced directive (AD), PREPARE plus reminder messages; (3) Letter, advanced directive (AD,) PREPARE plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome). All patients randomized to the intervention will be sent a patient-reported ACP engagement survey (secondary outcome).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Older Adults (age 65+) referred for surgical evaluation

排除标准

  • ACP on file within 3 years prior to surgery (UCSF and UCI) and 5 years (UMN)
  • Was previously randomized into intervention for a prior surgery during the 18-month study period

研究组 & 干预措施

Letter, AD, PREPARE, reminders

Other

Letter, AD, PREPARE plus reminder messages

干预措施: AD (Behavioral)

Letter, AD, PREPARE, reminders

Other

Letter, AD, PREPARE plus reminder messages

干预措施: PREPARE website (Behavioral)

Letter, AD, PREPARE, reminders

Other

Letter, AD, PREPARE plus reminder messages

干预措施: reminders (Behavioral)

Letter, AD, PREPARE, reminders, healthcare navigator

Other

Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome)

干预措施: Letter (Behavioral)

Letter, AD, PREPARE, reminders, healthcare navigator

Other

Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome)

干预措施: AD (Behavioral)

Letter, AD, PREPARE, reminders, healthcare navigator

Other

Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome)

干预措施: PREPARE website (Behavioral)

Letter, AD, PREPARE, reminders, healthcare navigator

Other

Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome)

干预措施: reminders (Behavioral)

Letter, AD, PREPARE, reminders, healthcare navigator

Other

Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome)

干预措施: healthcare navigator (Behavioral)

Letter, AD, PREPARE

Other

Letter about ACP, PREPARE advanced directive (AD), PREPARE website

干预措施: AD (Behavioral)

Letter, AD, PREPARE

Other

Letter about ACP, PREPARE advanced directive (AD), PREPARE website

干预措施: PREPARE website (Behavioral)

Letter, AD, PREPARE

Other

Letter about ACP, PREPARE advanced directive (AD), PREPARE website

干预措施: Letter (Behavioral)

Letter, AD, PREPARE, reminders

Other

Letter, AD, PREPARE plus reminder messages

干预措施: Letter (Behavioral)

结局指标

主要结局

Number of participants with clinically meaningful Advanced Care Planning

时间窗: 6 months

clinically meaningful ACP documentation (ACP-specific clinical notes, problem lists, Epic Smartforms or Smartphrases, advanced directives, Physician Orders for Life Sustaining Treatment, out of hospital do-not-resuscitate order, living wills, or CPT billing codes) available in the HCS EHR within 6 months of intervention.

次要结局

  • Patient Engagement Scores(6 months)
  • Patient Engagement Scores(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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