Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464471
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-12
Brief Title:
Comprehensive Health Assessment for My Plan Initial Implementation Study CHAMP Implementation Study
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Comprehensive Health Assessment for My Plan Implementation Study CHAMP Implementation Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 ie 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 itemsquestionnaires 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 tools 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 70y 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 Michaels 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
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 ie 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 itemsquestionnaires 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 tools 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 70y 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 Michaels 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None