A Personalised Approach Utilising the Frailty Index to Empower Consumers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Gastrointestinal Diseases

Intervention / Treatment
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* Other: Frailty Assessment
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled trial design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1- Personalised tailored approach<br>If patients are assigned to this group they will be asked to complete a frailty assessment which includes the Fraility Index short form, an assessment of grip strength, time to complete 5 sit-to-stands, balance test, and gait speed along with some questionnaires on comorbid medical condition. The treating Gastroenterologist will then go through the results of the frailty assessment with the patient and based on this information will discuss the benefits and risks associated with having a surveillance colonoscopy. The patient will then decide if they would like to go ahead with a surveillance colonoscopy and the treating Gastroenterologist will provide further advice as required. The frailty assessment is intended to be done at the time of the appointment with the specialist. However, operational requirements may dictate that e.g. a telehealth delivered occasion of service is done at a separate date. | Other: Frailty Assessment<br>* Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer<br>|
| Placebo Comparator: Group 2- Standard Care<br>Patients assigned to this group will discuss the benefits and risks associated with having a surveillance colonoscopy with the treating Gastroenterologist and will decide whether to proceed with the colonoscopy. | Other: Standard Care<br>* Standard care practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy surveillance