A Personalised Approach Utilising the Frailty Index to Empower Consumers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Frailty Assessment, Standard Care.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Diseases. Basic parameters: 65 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Personalised Approach Utilising the Frailty Index to Empower Consumers to Make Informed Decisions About Having a Colonoscopy to Avoid Low Value Care. A Prospective Randomized Controlled Trial.
Overview
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.
Detailed description
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.
Interventions
- Other Frailty Assessment
Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer - Other Standard Care
Standard care practice
Primary outcome measures
- Satisfaction with the respective outpatient service. [Time frame: Week 0]
- Patient satisfaction questions [Time frame: Week 0]
- Comprehensive Endoscopy Satisfaction Tool [Time frame: 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. [Time frame: Week 0-2 after consultation with doctor]
Secondary outcome measures (2)
- Number of participants with colorectal cancer related morbidity [Time frame: 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 [Time frame: Non colorectal cancer related mortality information within 5 years of the referral]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
Australia · 1 center
- Princess Alexandra Hospital — Woolloongabba
Identifiers
NCT: NCT05292989 · Frailty Study