A Personalised Approach Utilising the Frailty Index to Empower Consumers

Sponsor
Princess Alexandra Hospital, Brisbane, Australia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05292989
Collaborator
(none)
200
1
2
24
8.3

Study Details

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 or Royal Brisbane & Women's 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Frailty Assessment
  • Other: Standard Care
N/A

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 or Royal Brisbane & Women's 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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomized controlled trial designProspective randomized controlled trial design
Masking:
Single (Outcomes Assessor)
Masking Description:
Deidentified data
Primary Purpose:
Screening
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.
Anticipated Study Start Date :
Mar 26, 2022
Anticipated Primary Completion Date :
Mar 26, 2024
Anticipated Study Completion Date :
Mar 26, 2024

Arms and Interventions

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 an assessment of grip strength, time to complete 5 sit-to-stands, balance test, and gait speed along with some questionnaires on comorbid medical conditions. 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

Outcome Measures

Primary Outcome Measures

  1. Satisfaction with the respective outpatient service. [Week 0]

    '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.

  2. Patient satisfaction questions [Week 0]

    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

  3. Comprehensive Endoscopy Satisfaction Tool [Week 2-4 After colonoscopy procedure]

    This captures the overall satisfaction with the service events (endoscopic procedure and relevant components including the pre-procedure assessment). Higher scores greater satisfaction

  4. 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]

    • 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

  1. Number of participants with colorectal cancer related morbidity [Colorectal cancer related morbidity within 5 years of the referral]

    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

  2. Number of participants with non colorectal cancer related mortality information within 5 years of the referral [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Princess Alexandra Hospital Woolloongabba Queensland Australia 4212

Sponsors and Collaborators

  • Princess Alexandra Hospital, Brisbane, Australia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gerald Holtmann, Director of Gastroenterology & Hepatology, Princess Alexandra Hospital, Brisbane, Australia
ClinicalTrials.gov Identifier:
NCT05292989
Other Study ID Numbers:
  • Frailty Study
First Posted:
Mar 23, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gerald Holtmann, Director of Gastroenterology & Hepatology, Princess Alexandra Hospital, Brisbane, Australia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022