Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05102890 |
| Other study ID # |
MP-02-2022-10160 |
| Secondary ID |
2022-IMPV-309559 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 22, 2021 |
| Est. completion date |
November 1, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Centre hospitalier de l'Université de Montréal (CHUM) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
