Comprehensive Health Assessment for My Plan: Initial Implementation Study (CHAMP Implementation Study)
Comprehensive Health Assessment for My Plan: Implementation Study (CHAMP Implementation Study)
Study Overview
Status
Conditions
Intervention / Treatment
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 (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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Martine Puts, PhD RN
- Phone Number: 416-978-6059
- Email: martine.puts@utoronto.ca
Study Contact Backup
- Name: Shabbir Alibhai, MD MSc
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G2C4
- Recruiting
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Older adults completing the CHAMP tool before treatment decision is made
Eligible participants who consent to the study will be asked to complete questionnaires about socio-demographic characteristics, literacy, and technology comfort.
Subsequently, participants will be asked to complete the CHAMP tool at home or in the clinic before the participants' medical appointment with the clinician.
Next, participants will see the clinician for the consultation.
Approximately one week after the consultation, participants will be asked to complete 3 questionnaires about the participants' experience and satisfaction with the CHAMP tool.
|
The CHAMP tool is a self reported online tool that has been developed to increase patients' accessibility to geriatric assessment and improve treatment decision making.
The tool includes questions about function, mobility, cognition, nutrition, social support, depression substance use disorders, and miscellaneous items.
Based on usability testing in the previous phase of this study, the tool can be completed in approximately 10-15 minutes.
The tool generates a summary report with recommendations for patients and clinicians.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completeness of the CHAMP tool
Time Frame: 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.
|
Within one week from medical appointment
|
|
Time to fill out the CHAMP tool
Time Frame: 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.
|
Within one week from medical appointment
|
|
Satisfaction with the CHAMP tool
Time Frame: 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.
|
Older adults - within one week of the participants' medical appointment. physicians - within one week of the last study patient.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in proposed treatment plan
Time Frame: Within 48 hours of the appointment with an older adults who has completed the CHAMP tool
|
The impact of the CHAMP tool on proposed treatment plan will be measured through an adapted questionnaire which the investigators used in previous studies.
It measures if treatment was changed at all (yes/no), and if changed, then modified intensity, alternate modality, best supportive care only, or other.
|
Within 48 hours of the appointment with an older adults who has completed the CHAMP tool
|
|
Changes in supportive care strategies
Time Frame: Within 48 hours of the appointment with an older adult who completed the CHAMP tool
|
The impact of the the CHAMP tool on supportive care strategies will be measured through a survey that will be completed by the treating clinician.
Additionally, the investigators will record the number of geriatric issues identified in the CHAMP summary and the number and type of recommendations provided to older adults and clinicians.
The investigators will then review the charts of all older adults who completed CHAMP to abstract data on recommendations made by clinicians, referrals made to geriatrics and other health care providers, and other tests requested based on the recommendations.
|
Within 48 hours of the appointment with an older adult who completed the CHAMP tool
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martine Puts, PhD RN, University of Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CTO#4200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.