A Personalised Approach Utilising the Frailty Index to Empower Consumers

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Frailty Assessment
  Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer
• Другое Standard Care
  Standard care practice

Первичные конечные точки

• Satisfaction with the respective outpatient service. [Срок оценки: Week 0]
• Patient satisfaction questions [Срок оценки: Week 0]
• Comprehensive Endoscopy Satisfaction Tool [Срок оценки: 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. [Срок оценки: Week 0-2 after consultation with doctor]

Вторичные конечные точки (2)

• Number of participants with colorectal cancer related morbidity [Срок оценки: 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 [Срок оценки: Non colorectal cancer related mortality information within 5 years of the referral]

Критерии участия

Критерии включения

• Patients aged over 65 years of age
• Ability to understand the study instructions and answering questionnaires

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

Австралия · 1 центр

• Princess Alexandra Hospital — Woolloongabba

Идентификаторы

NCT: NCT05292989 · Frailty Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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