A Personalised Approach Utilising the Frailty Index to Empower Consumers

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Other: Frailty Assessment; Other: Standard Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4212
      • Recruiting
      • Princess Alexandra Hospital
      • Contact: Natasha Koloski, PhD; Phone Number: 0407126897; Email: Natasha.Koloski@newcastle.edu.au
      • Contact: Gerald Holtmann, MD; Phone Number: 61 7 3176 2613; Email: Gerald.Holtmann@health.qld.gov.au
      • Principal Investigator: Gerald Holtmann, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 98 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1- Personalised tailored approach; 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; Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer
Placebo Comparator: Group 2- Standard Care; 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; Standard care practice

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Princess Alexandra Hospital, Brisbane, Australia

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 26, 2024

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: colonoscopy surveillance
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: Frailty Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No