A Personalised Approach Utilising the Frailty Index to Empower Consumers

Gastrointestinal Diseases Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292989
• Other study ID #: Frailty Study
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: October 26, 2024

Study information

• Verified date: April 2024
• Source: Princess Alexandra Hospital, Brisbane, Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 26, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Frailty
• Gastrointestinal Diseases

Intervention

Other:
• Frailty Assessment
Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer
• Standard Care
Standard care practice

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Princess Alexandra Hospital, Brisbane, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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