Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06464471 |
| Other study ID # |
CTO#4200 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2024 |
| Est. completion date |
August 1, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
University of Toronto |
| Contact |
Martine Puts, PhD RN |
| Phone |
416-978-6059 |
| Email |
martine.puts[@]utoronto.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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:
A total of 210 older adults (70+y) who have been referred to any kind of non-oncological
surgery will be recruited from 4 centres -University Health Network, Sunnybrook Health
Sciences Centre, St. Michael's Hospital and Mount Sinai Hospital. Older adults who agree to
participate will be asked to provide information on sociodemographic characteristics and
comfort with technology prior to completing the CHAMP tool. Subsequently, participants will
be asked to complete the tool either prior to clinic (at home via internet) or in clinic (via
iPad) prior to the participants' consultation with the clinician. Following completion of the
CHAMP tool and prior to treatment decision making visit with the clinician, a member of the
research team will provide the CHAMP results to the clinician. The clinician will be asked
the proposed treatment plan and whether the patient is fit, vulnerable, or frail using
standard definitions. Then, the clinician will be asked of whether the treatment plan intent
is being modified based on the CHAMP tool. The CHAMP tool also contains evidence-based
recommendations for clinicians on strategies to reduce risk and address geriatric domains.
Surveys will be used to assess participants' and clinicians' satisfaction with the tool.
