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临床试验/NCT07175961
NCT07175961尚未招募3 期

Improving Survivorship for Critically Ill Patients Aged 65 and Over

Australian and New Zealand Intensive Care Research Centre4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
300
试验地点
4
主要终点
Hierarchical composite endpoint of death, avoidable hospital readmission and new global disability measured using the World Health Organisation Disability Schedule (WHODAS) 2.0 12L at 90 days after randomisation.

研究概览

简要总结

IMPROVE-65 is a randomised control trial designed specifically for people aged over 65 who have survived critical illness. It aims to support patients and general practitioners by providing timely, personalised information to help them work together to make informed goals and decisions about their care after hospital discharge. The aim of the study is to improve recovery and avoid preventable hospital readmissions.

详细描述

Critical illness and intensive care unit (ICU) admissions represent significant life events that carry substantial risks for long-term health consequences. An estimated 50% of Australians will be admitted to ICU during their lifetime, placing them at considerable risk of new or worsened physical, cognitive, and psychological dysfunction following discharge. Among ICU patients, those aged 65 years and older constitute the majority, accounting for 52.5% of all admissions. Older adults experience disproportionately higher burdens of illness severity, frailty, and comorbidities, which complicate both the management of acute critical illness and the subsequent recovery process. These factors contribute to longer ICU and hospital stays, increased mortality, and a heightened risk of long-term disability. Previous research shows that nearly 40% of Australian ICU patients aged over 65 years are living with significant disability six months after discharge.

Despite the growing number of ICU survivors and the known risks of long-term morbidity, there is currently no formal or standardised system of follow-up care in Australia to monitor or support recovery. Survivors of critical illness have frequently reported fragmented transitions from hospital to home, poor communication between tertiary and primary care providers, and insufficient support to prevent or manage new disability. General practitioners (GPs), often the primary source of ongoing care, have similarly identified a lack of communication and the absence of prioritised discharge summaries as barriers to effective post-ICU care.

Building on these insights, previous work has explored innovative models of care to support functional recovery. This includes care navigation to reduce avoidable hospitalisations among high-risk patients, digital tools to improve communication between hospital and primary care, and technology-enabled goal-setting to facilitate rehabilitation. These initiatives demonstrate the potential for digital and telehealth approaches to bridge existing gaps in care continuity and patient-centred recovery.

This trial will determine if a multifaceted recovery navigated approach to coordinate and deliver timely and individualised post hospital care and recovery goals, will reduce the burden of new disability at 3 months following discharge from hospital after critical illness. Additionally, the trial will review the cost effectiveness at 6 months after randomisation. By enabling more effective communication between ICU survivors and their GPs, improving access to health information, and promoting shared decision-making, IMPROVE-65 aims to enhance the quality of survivorship, reduce new disability, and minimise healthcare costs and avoidable hospital readmissions for critically ill older adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Was admitted to ICU for at least 48 hours
  • is aged 65 years or older at the time of hospital admission
  • Is alive and ready for hospital discharge
  • Is expected to survive for 6 months beyond hospital discharge (e.g. not discharged on palliative care)
  • Has new disability at hospital discharge measured using the global disability scale

排除标准

  • Is not expected to reside in Australia for 3 months following randomisation.
  • Is not expected to be living at home within 2 weeks of acute hospital discharge (e.g. prolonged inpatient rehabilitation)
  • Is unable to identify a GP or GP clinic and/or are unable or unwilling to attend a GP appointment scheduled by the recovery navigator.
  • Has an existing recovery or nurse navigator as part of their routine clinical care to assist with planning their care after hospital discharge

结局指标

主要结局

Hierarchical composite endpoint of death, avoidable hospital readmission and new global disability measured using the World Health Organisation Disability Schedule (WHODAS) 2.0 12L at 90 days after randomisation.

时间窗: From randomisation until 90 days post randomisation.

The hierarchical outcome of interest is a combination of out-of-hospital mortality, need for hospital readmission and WHODAS 2.0 score. The primary composite endpoint will be analysed using the win odds to account for ties.

次要结局

  • Avoidable acute hospital readmissions to day 90(From randomisation until day 90 post randomisation)
  • Patient Activation Measure (PAM) at day 90(From randomisation until Day 90 post randomisation.)
  • Activities of Daily Living at Day 90(From randomisation until Day 90 outcome assessment is completed.)
  • Self-rated health at Day 90(From randomisation until Day 90)
  • Self-rated health at Day 180(From randomisation to Day 180)
  • New disability at Day 180(From randomisation until Day 180 assessment is complete)
  • Activities of daily living at day 90(From randomisation until Day 90)
  • Activities of daily living at day 180(From randomisation until day 180)
  • Instrumental activities of daily living at day 90(From randomisation until day 90)
  • Instrumental activities of daily living at day 180(From randomisation until day 180)
  • Participant cognition at day 180(At day 180 from randomisation)
  • Post traumatic stress disorder at day 180(Measured at Day 180 after randomisation)
  • All-cause mortality to day 180(From randomisation until Day 180 outcome assessment is completed.)
  • Avoidable acute hospital readmissions to day 90(From randomisation until day 90 post randomisation)
  • Patient Activation Measure (PAM) at day 90(From randomisation until Day 90 post randomisation.)
  • Activities of Daily Living at Day 90(From randomisation until Day 90 outcome assessment is completed.)
  • Self-rated health at Day 90(From randomisation until Day 90)
  • Activities of Daily Living at Day 180(From randomisation until Day 180)
  • Self-rated health at Day 180(From randomisation to Day 180)
  • New disability at Day 90(From randomisation to Day 90 outcome assessment is completed.)
  • New disability at Day 180(From randomisation until Day 180 assessment is complete)
  • Activities of daily living at day 90(From randomisation until Day 90)
  • Activities of daily living at day 180(From randomisation until day 180)
  • Instrumental activities of daily living at day 90(From randomisation until day 90)
  • Instrumental activities of daily living at day 180(From randomisation until day 180)
  • Anxiety and Depression at day 180(From randomisation until Day 180 outcome assessment is completed.)
  • Participant cognition at day 180(At day 180 from randomisation)
  • Post traumatic stress disorder at day 180(Measured at Day 180 after randomisation)
  • Cost-effectiveness of the intervention at day 180(From randomisation until Day 180.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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