Clinical trial NCT05292989: A Personalised Approach Utilising the Frailty Index to Empower Consumers
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Diseases
Keywords: colonoscopy surveillance
Lead sponsor: Princess Alexandra Hospital, Brisbane, Australia
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial design
Primary purpose: SCREENING

Brief summary: 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.

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

Primary outcomes:
measure: Satisfaction with the respective outpatient service.
timeFrame: Week 0
measure: Patient satisfaction questions
timeFrame: Week 0
measure: Comprehensive Endoscopy Satisfaction Tool
timeFrame: Week 2-4 After colonoscopy procedure
measure: 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.
timeFrame: Week 0-2 after consultation with doctor
Secondary outcomes:
measure: Number of participants with colorectal cancer related morbidity
timeFrame: Colorectal cancer related morbidity within 5 years of the referral
measure: Number of participants with non colorectal cancer related mortality information within 5 years of the referral
timeFrame: Non colorectal cancer related mortality information within 5 years of the referral
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
References: