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临床试验/NCT06464471
NCT06464471招募中不适用

Comprehensive Health Assessment for My Plan: Implementation Study (CHAMP Implementation Study)

University of Toronto2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
210
试验地点
2
主要终点
Time to fill out the CHAMP tool

研究概览

简要总结

The current standard preoperative assessment does not consider the needs of older adults undergoing non-oncological surgery. To enhance the treatment decision-making and planning for older adult surgical patients, the British Geriatric Society and the American Society of Colon and Rectal Surgeons recommend the implementation of preoperative GA for all older adults. Geriatric assessment (GA) predicts treatment toxicity and overall mortality in older adults with complex health problems. However, in-person GA may not be feasible in several clinical settings for various reasons, including lack of training, time, or access to advanced geriatric services. These challenges can be minimized through a self-reported online GA that can be completed by patients prior to the participants' medical appointment. In a previous study, the investigators developed a self-reported online GA, known as the Comprehensive Health Assessment for My Cancer treatment Plan (CHAMP), which was used in geriatric oncology to increase accessibility to GA for older adults with cancer. In this study, the aim is to deploy the CHAMP tool to various clinics across 4 institutions and assess feasibility outcomes, as well as the efficacy of the CHAMP tool in the identification of geriatric issues and the development of supportive care.

详细描述

Introduction:

The aging population in Canada is greatly contributing to the growing number of older adults undergoing elective surgery. Approximately 48% of inpatient surgeries in Canada were aged at least 65 years old in 2021. Currently, the standard preoperative assessment does not include evaluations designed to address the needs of older adults. Increasing age is associated with changing physiology along with increasing comorbidity, polypharmacy, functional impairment, and cognitive impairment. Frailty (reduced physiologic reserve) is common but not universal. However, frailty in surgical settings vary between 13% to 84%, depending on the frailty evaluation tool used. Various systematic reviews have also identified an association between frailty and adverse events after surgery, including increased rates of postoperative complications, mortality, and discharge to a location other than home. The British Geriatric Society and the American Society of Colon and Rectal Surgeons thus recommend GA for OAs requiring non-oncological surgery. A GA has 8 key assessment domains (i.e. comorbidity, functional status, medications, falls risk, nutrition, social supports, cognition, mood), each of which is relevant to the "staging of the aging" and development of personalized treatment plans for older adults. In non-oncological surgery settings, GA can help reduce the risk of adverse outcomes of surgery, and optimize the health and functional status of older adults in the preoperative stage. However, GA has not been widely implemented in surgical settings due to the lack of time, training, and access to advanced geriatric services. An innovative, scalable solution is a patient self-completed electronic GA tool.

The investigators designed the CHAMP tool, a self-reported online GA that can be completed by older adults at home or in the clinic prior to the participants' medical appointment. The process for developing CHAMP included the following steps: i) a systematic review and a Delphi Panel of expert clinicians to select the final domains and items/questionnaires; ii) design sessions with older adults with cancer to develop the layout and contact of the tool; iii) usability sessions with older adults with cancer to finalize the tool; and iv) design sessions with oncology clinicians to develop the tool's clinician interface. The CHAMP tool is now ready for field testing.

The study objectives are to measure feasibility outcomes and efficacy of the tool in the identification of geriatric issues and development of care plan strategies.

Methods:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Patients aged 70 years old and over who have been referred to any kind of non-oncological surgery
  • Able to speak English
  • Able to provide informed consent

排除标准

  • 未提供

结局指标

主要结局

Time to fill out the CHAMP tool

时间窗: Within one week from medical appointment

In minutes, recorded via user interaction logs which will include data such as user's actions and interactions with the actual interface such as clicks, point-an-select actions, use of back button, etc.), and whether the participant completed it alone or needed help.

Satisfaction with the CHAMP tool

时间窗: Older adults - within one week of the participants' medical appointment. physicians - within one week of the last study patient.

Measured via open-ended questions and a brief survey.

Completeness of the CHAMP tool

时间窗: Within one week from medical appointment

Proportion of older adults who consented to the study who completed the CHAMP tool and had a discussion with the participants' physician about the CHAMP results.

次要结局

  • Changes in supportive care strategies(Within 48 hours of the appointment with an older adult who completed the CHAMP tool)
  • Change in proposed treatment plan(Within 48 hours of the appointment with an older adults who has completed the CHAMP tool)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martine Puts

Principal investigator

University of Toronto

研究点 (2)

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