跳至主要内容
临床试验/NCT05102890
NCT05102890已完成不适用

ESOGER PC: Implementation of a Socio-geriatric Telemedicine Tool in Primary Care to Support Needs Assessment for Older Adults

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2021年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
452
试验地点
2
主要终点
Change from baseline quality of life score at 3 months

研究概览

简要总结

The pandemic has served a major catalyst propelling telehealth to the frontline of health care. For older adults who often live many chronic health problems, telehealth, which means to give medical check-ups by phone, email or by video conferencing, has become a lifeline to accessing a doctor when they need one. Even without the pandemic, telehealth can help ease access to care, especially for those living in rural areas who often need to travel long distances to see a doctor. However, there is a lack of telehealth tools that have been adapted for older patients. For example, only a few studies have looked at how well they work in improving outcomes for older patients like their quality of life, autonomy and use of health services. Telehealth could also lead to unfair differences between urban and rural patients who don't have the same access to technology. All these factors can make it difficult for family doctors to feel confident about using telehealth for their older patients. With telehealth likely to become mainstream for family doctors and older patients even after the pandemic, it is important to support the growing use of telehealth through tools that are adapted for older patients, fair and based on reliable evidence. This project aims to support the shift to telehealth in caring for older people living in the community by implementing and evaluating ESOGER, a telehealth support tool, in family medicine clinics. The ESOGER tool provides s a quick and reliable evaluation of the health and social needs of older patients. It can be done by phone making it accessible for everyone. This tool is expected to give family doctors a standardized and feasible way to determine the health and social needs of their older patients using telehealth which will help improve patients' autonomy, quality of life and health service use. The tool will be tested in four clinics in both urban and rural regions of Quebec to find out if it helped doctors better address their patients' needs and helped patients to live well at home. The study investigators will also study any differences in improvement between urban and rural older patients. They will discuss the results with the clinics and patient-partners to learn from their experiences and make the telehealth tool and the way to use it be as optimal as possible for family doctors to help maintain the health, quality of life and autonomy of older patients living at home.

详细描述

The goal of this project is to provide a readily-available solution to support an evidence-based shift to telemedicine in primary care by implementing and evaluating ESOGER as a pre-consultation telemedicine tool for older adults. Specifically, the objective of this project is to implement and evaluate the effectiveness of the ESOGER telemedicine tool in improving patient outcomes in rural and urban older patients. The effectiveness of the tool will be determined through a pilot randomized controlled trial in four university-affiliated interprofessional primary care clinics in the province of Quebec, Canada. Specifically, a 3-month pragmatic, multi-center, individually randomized, open-label and parallel-group trial design will be used. This design will evaluate the effectiveness of the tool under real-world conditions, allowing for site-specific adaptations to its implementation based on their needs and resources and producing results that can be generalized in routine practice settings. A 1:1 randomization ratio will be used to randomize patients to either receive the ESOGER tool or receive usual care. Participants will consist of those 65 years old and older with an upcoming virtual or in-person visit at one of the participating clinics who have consented to participate. A total of 480 participants expected to be recruited over the 3-month period. Baseline data on sociodemographic characteristics, self-reported quality of life and prior health service utilization will be collected by phone using an online questionnaire for patients in both study groups. The primary endpoint will consist of the EQ-5D score at the 3-month follow-up. The EQ-5D is a widely-used and validated 5-item patient-reported outcome measures (PROMS) tool that reflects patients' current perspective of their health, autonomy and quality of life. The EQ-5D index lies on a continuum from worst to best health, ranging from less than 0 to 1. Secondary endpoints will be unplanned health service use since the previous assessment (in last 3 months). An intention-to-treat analysis will be carried out for all study outcomes. A mixed effect model will be used to estimate the association between the use of ESOGER and outcomes accounting for the clustering of patients within study sites. A two-way interaction between the intervention group (ESOGER vs control group) and rural status (urban vs rural) will be included in the model to examine differences in impact for urban and rural older patients and potential areas of inequity. Analyses and interpretations will be carried out in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

研究设计

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

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

  • 65 years old and older
  • Patient of the participating primary care clinic with upcoming virtual or in-person primary care visit

排除标准

  • unable to provide informed consent in English or French

结局指标

主要结局

Change from baseline quality of life score at 3 months

时间窗: The EQ-5D will be measured at study entry (time 0) and at study follow-up (3 months) for both the intervention and control group.

The Euro-Qol 5D (EQ-5D), a highly validated quality of life questionnaire, will be used to measure the primary outcome. The EQ-5D score ranges from 0 (indicating worst health) to 1 (best health). The change in quality of life score will be measured as the difference in the EQ-5D score at 3 months minus the EQ-5D score at baseline.

次要结局

未报告次要终点

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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