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.
Verified date | April 2024 |
Source | Princess Alexandra Hospital, Brisbane, Australia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Lead Sponsor | Collaborator |
---|---|
Princess Alexandra Hospital, Brisbane, Australia |
Australia,
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 |
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