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Clinical Trials/NCT05292989
NCT05292989
Recruiting
N/A

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.

Princess Alexandra Hospital, Brisbane, Australia1 site in 1 country200 target enrollmentAugust 14, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gastrointestinal Diseases
Sponsor
Princess Alexandra Hospital, Brisbane, Australia
Enrollment
200
Locations
1
Primary Endpoint
Satisfaction with the respective outpatient service.
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 14, 2023
End Date
February 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Princess Alexandra Hospital, Brisbane, Australia
Responsible Party
Principal Investigator
Principal Investigator

Gerald Holtmann

Director of Gastroenterology & Hepatology

Princess Alexandra Hospital, Brisbane, Australia

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

Outcomes

Primary Outcomes

Satisfaction with the respective outpatient service.

Time Frame: Week 0

'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.

Patient satisfaction questions

Time Frame: Week 0

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

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

• 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.

Comprehensive Endoscopy Satisfaction Tool

Time Frame: Week 2-4 After colonoscopy procedure

This captures the overall satisfaction with the service events (endoscopic procedure and relevant components including the pre-procedure assessment). Higher scores greater satisfaction

Secondary Outcomes

  • Number of participants with non colorectal cancer related mortality information within 5 years of the referral(Non colorectal cancer related mortality information within 5 years of the referral)
  • Number of participants with colorectal cancer related morbidity(Colorectal cancer related morbidity within 5 years of the referral)

Study Sites (1)

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