A Personalised Approach Utilising the Frailty Index to Empower Consumers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorPrincess Alexandra Hospital, Brisbane, Australia

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged over 65 years of age

Ability to understand the study instructions and answering questionnaires

Disqualifiers

Inability to consent or participate in the assessments (e.g. frailty assessment) that are required as part of this project.

Lack of informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Frailty Assessment

    Other intervention

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

  • Standard Care

    Other intervention

    Standard care practice

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Group 1- Personalised tailored approachExperimental treatment 1 intervention
Group B: Group 2- Standard CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 0
2

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

Time frame
Week 0
3

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

Time frame
Week 2-4 After colonoscopy procedure
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.

• 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 outcomes

1

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

Time frame
Colorectal cancer related morbidity within 5 years of the referral
2

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

Time frame
Non colorectal cancer related mortality information within 5 years of the referral

Other outcomes

Sponsors and contacts

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