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Not yet recruiting NCT07175961

Improving Survivorship for Critically Ill Patients Aged 65 and Over

Phase III Interventional Critical Illness Recovery Outcomes Care Coordination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multicomponent telehealth care coordination.
Who it may be relevant to
Registry conditions: Critical Illness, Recovery Outcomes, Care Coordination. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Other Multicomponent telehealth care coordination
    Participants randomised into the intervention group will be assigned a recovery navigator prior to discharge from hospital. The recovery navigator will provide the participant with a study tailored discharge summary, arrange the patients first appointment with their general practitioner and will ensure medications are reconciled prior to hospital discharge. The recovery coordinator will arrange weekly calls with the participant for the first 4 weeks and then fortnightly until week 12 to set reco

Primary outcome measures

  • 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. [Time frame: From randomisation until 90 days post randomisation.]
Secondary outcome measures (12)
  • All-cause mortality to day 180 [Time frame: From randomisation until Day 180 outcome assessment is completed.]
  • Avoidable acute hospital readmissions to day 90 [Time frame: From randomisation until day 90 post randomisation]
  • Patient Activation Measure (PAM) at day 90 [Time frame: From randomisation until Day 90 post randomisation.]
  • Activities of Daily Living at Day 90 [Time frame: From randomisation until Day 90 outcome assessment is completed.]
  • Self-rated health at Day 90 [Time frame: From randomisation until Day 90]
  • Activities of Daily Living at Day 180 [Time frame: From randomisation until Day 180]
  • Self-rated health at Day 180 [Time frame: From randomisation to Day 180]
  • New disability at Day 90 [Time frame: From randomisation to Day 90 outcome assessment is completed.]
  • New disability at Day 180 [Time frame: From randomisation until Day 180 assessment is complete]
  • Activities of daily living at day 90 [Time frame: From randomisation until Day 90]
  • Activities of daily living at day 180 [Time frame: From randomisation until day 180]
  • Instrumental activities of daily living at day 90 [Time frame: From randomisation until day 90]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Australia · 2 centers
  • Cabrini Hospital Malvern — Melbourne
  • Monash Health — Melbourne

Identifiers

NCT: NCT07175961 · ANZIC-RC/CH007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗