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A Personalised Approach Utilising the Frailty Index to Empower Consumers

Primary Purpose

Gastrointestinal Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Frailty Assessment
Standard Care
Sponsored by
Princess Alexandra Hospital, Brisbane, Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Gastrointestinal Diseases focused on measuring colonoscopy surveillance

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1- Personalised tailored approach

Group 2- Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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
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.

Secondary Outcome Measures

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
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

Full Information

First Posted
March 1, 2022
Last Updated
June 25, 2023
Sponsor
Princess Alexandra Hospital, Brisbane, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT05292989
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
October 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Alexandra Hospital, Brisbane, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases
Keywords
colonoscopy surveillance

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial design
Masking
Outcomes Assessor
Masking Description
Deidentified data
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1- Personalised tailored approach
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2- Standard Care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Frailty Assessment
Intervention Description
Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard care practice
Primary Outcome Measure Information:
Title
Satisfaction with the respective outpatient service.
Description
'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.
Time Frame
Week 0
Title
Patient satisfaction questions
Description
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
Time Frame
Week 0
Title
Comprehensive Endoscopy Satisfaction Tool
Description
This captures the overall satisfaction with the service events (endoscopic procedure and relevant components including the pre-procedure assessment). Higher scores greater satisfaction
Time Frame
Week 2-4 After colonoscopy procedure
Title
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.
Description
• 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
Secondary Outcome Measure Information:
Title
Number of participants with colorectal cancer related morbidity
Description
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
Time Frame
Colorectal cancer related morbidity within 5 years of the referral
Title
Number of participants with non colorectal cancer related mortality information within 5 years of the referral
Description
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
Time Frame
Non colorectal cancer related mortality information within 5 years of the referral

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4212
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Personalised Approach Utilising the Frailty Index to Empower Consumers

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