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NCT Number: NCT05292989

A Personalised Approach Utilising the Frailty Index to Empower Consumers

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.

Recruiting

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Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frailty Assessment

Other

Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer

Standard care

Other

Standard care practice

Primary outcomes

  1. Satisfaction with the respective outpatient service.

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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 outcomes

  1. Number of participants with colorectal cancer related morbidity

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Princess Alexandra Hospital, Brisbane, Australia

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2022
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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