A Personalised Approach Utilising the Frailty Index to Empower Consumers
Frailty is a common clinical syndrome in older adults that may carry an increased risk for poor health outcomes including falls, hospitalisation, and mortality. Having a colonoscopy can be associated with potential adverse outcomes in frail patients. At present, however, frailty is not routinely assessed in gastroenterological clinical practice.
In a prospective randomised controlled study consenting patients over 65 years at the Princess Alexandra Hospital will receive either a) personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer or b) current standard practice in regards to having a surveillance colonoscopy to determine the effects on patient satisfaction and percentage of colonoscopies avoided.
Study details:
Frailty is a common clinical syndrome in older adults that may carry an increased risk for poor health outcomes including falls, hospitalisation, and mortality. Having a colonoscopy can be associated with potential adverse outcomes in frail patients. At present, however, frailty is not routinely assessed in gastroenterological clinical practice.
In a prospective randomised controlled study consenting patients over 65 years at the Princess Alexandra Hospital will receive either a) personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer or b) current standard practice in regards to having a surveillance colonoscopy to determine the effects on patient satisfaction and percentage of colonoscopies avoided. It is expected that engagement with patients and clinicians in regards to frailty will address expectations and subsequently support the ability of patients/consumers and clinicians to make informed decisions that minimise risks and maximise benefits in regards to surveillance colonoscopies.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Patients aged over 65 years of age
- Ability to understand the study instructions and answering questionnaires
Exclusion criteria
- Inability to consent or participate in the assessments (e.g. frailty assessment) that are required as part of this project.
- Lack of informed consent
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
SCREENING
Phase
- NA
Study ID
NCT05292989
Intervention or treatment
OTHER: Frailty Assessment
OTHER: Standard Care
Conditions
- Gastrointestinal Diseases
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Research sites nearby
Closest Location:
Princess Alexandra Hospital
Select from list below to view details:
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
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Who is running the clinical trial?
Princess Alexandra Hospital, Brisbane, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Group 1- Personalised tailored approach
| Other: Frailty Assessment |
PLACEBO_COMPARATOR: Group 2- Standard Care
| Other: Standard Care |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with the respective outpatient service. | 'Based only upon your recent experience when you received a consultation in relation to a potential future endoscopic test, how likely are you to recommend the respective health care organization (PAH or RWBH) to a friend, family member or colleague?.' Please rate your experience on a scale of 1 to 10, where 1 is extremely unlikely and 10 extremely likely. | Week 0 |
| Patient satisfaction questions | Patients will be asked Overall, how would you rate the care you received? 1. Very good 2. Good 3. Adequate 4. Poor 5. Very poor Were you involved as much as you wanted to be in decisions about your care and treatment? 1. Yes, definitely 2. Yes, to some extent 3. No, not enough How much information about your condition or treatment was given to you? 1. The right amount 2. Too much 3. Not enough | Week 0 |
| Comprehensive Endoscopy Satisfaction Tool | This captures the overall satisfaction with the service events (endoscopic procedure and relevant components including the pre-procedure assessment). Higher scores greater satisfaction | Week 2-4 After colonoscopy procedure |
| Percentage of consumers in the intervention and control group that are referred for a surveillance colonoscopies who decide not have the procedure based upon the information provided. | • Percentage of consumers in the intervention and control group that are referred for a surveillance colonoscopies who decide not have the procedure based upon the information provided. | Week 0-2 after consultation with doctor |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with colorectal cancer related morbidity | The number of participants with colorectal cancer related morbidity within 5 years of the referral- including number of patients with clinical diagnoses, hospitalizations, emergency presentations, surgeries, medications | Colorectal cancer related morbidity within 5 years of the referral |
| Number of participants with non colorectal cancer related mortality information within 5 years of the referral | The number of participants with non colorectal cancer related mortality information within 5 years of the referral - including number of patients with clinical diagnoses, hospitalizations, outpatient visits, emergency presentations, surgeries | Non colorectal cancer related mortality information within 5 years of the referral |
References
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