Improving Survivorship for Critically Ill Patients Aged 65 and Over
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
HEALTH_SERVICES_RESEARCH
Phase
- PHASE3
Study ID
NCT07175961
Intervention or treatment
OTHER: Multicomponent telehealth care coordination
Conditions
- Critical Illness
- Recovery Outcomes
- Care Coordination
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Cabrini Hospital Malvern
Select from list below to view details:
Cabrini Hospital Malvern
Melbourne, Victoria, Australia
Monash Health
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Australian and New Zealand Intensive Care Research Centre
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
NO_INTERVENTION: Control: Standard care
| |
EXPERIMENTAL: Intervention
| Other: Multicomponent telehealth care coordination |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From randomisation until 90 days post randomisation. |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality to day 180 | Not Specified | From randomisation until Day 180 outcome assessment is completed. |
| Avoidable acute hospital readmissions to day 90 | Measured by reviewing the number of emergency admissions to hospital participants had between randomisation and day 90. | From randomisation until day 90 post randomisation |
| Patient Activation Measure (PAM) at day 90 | Not Specified | From randomisation until Day 90 post randomisation. |
| Activities of Daily Living at Day 90 | Measured with the EuroQoL 5-Dimension, 5-Level (EQ-5D-5L). Five questions are asked relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has five response options from 1 (no problems) to 5 (extreme problems). | From randomisation until Day 90 outcome assessment is completed. |
| Self-rated health at Day 90 | Measured using the EQ-Visual Analogue Scale (EQ-VAS) at Day 180. Measured on a scale of 0 to 100. The participant is asked to rate their health on the day of the assessment with 0 being the worst health and 100 being the best. | From randomisation until Day 90 |
| Activities of Daily Living at Day 180 | Measured with the EuroQoL 5-Dimension, 5-Level (EQ-5D-5L). Five questions are asked relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has five response options from 1 (no problems) to 5 (extreme problems). | From randomisation until Day 180 |
| Self-rated health at Day 180 | Measured using the EQ-Visual Analogue Scale (EQ-VAS) at Day 180. Measured on a scale of 0 to 100. The participant is asked to rate their health on the day of the assessment with 0 being the worst health and 100 being the best. | From randomisation to Day 180 |
| New disability at Day 90 | Measured with the World Health Organization Disability Assessment Schedule 2.0 Proxy Administered. (WHODAS 2.0 12L). New disability is considered a change in WHODAS \>10% from baseline). The participant is asked 12 questions relating to cognition, mobility, self-care, interacting with people, life activities and participation. Each question is ranked on a 5-point Likert scale from 0 (None) to 4 (Extreme or cannot do). The total score is the sum of all 12 question and can range from 0 to 48 with a higher score indicating a greater degree of disability or function. | From randomisation to Day 90 outcome assessment is completed. |
| New disability at Day 180 | Measured with the World Health Organization Disability Assessment Schedule 2.0 Proxy Administered. (WHODAS 2.0 12L). New disability is considered a change in WHODAS \>10% from baseline). The participant is asked 12 questions relating to cognition, mobility, self-care, interacting with people, life activities and participation. Each question is ranked on a 5-point Likert scale from 0 (None) to 4 (Extreme or cannot do). The total score is the sum of all 12 question and can range from 0 to 48 with a higher score indicating a greater degree of disability or function. | From randomisation until Day 180 assessment is complete |
| Activities of daily living at day 90 | Measured using the Katz Index of Independence in Activities of Daily Living (ADL) which assesses basic activities of daily living. The participant is asked about 6 categories of daily living and given a score of 0 or 1 based on their ability to complete the task either independently or with support. A final score between 0 and 6 is calculated, with the higher score indicating greater independence. | From randomisation until Day 90 |
| Activities of daily living at day 180 | Measured using the Katz Index of Independence in Activities of Daily Living (ADL) which assesses basic activities of daily living. The participant is asked about 6 categories of daily living and given a score of 0 or 1 based on their ability to complete the task either independently or with support. A final score between 0 and 6 is calculated, with the higher score indicating greater independence. | From randomisation until day 180 |
| Instrumental activities of daily living at day 90 | Measured using the Lawton Instrumental Activities of Daily Living Scale. Eight categories of daily activities are asked, and the participant is scored for each category with either a 0 or a 1 based on the highest functional level for each activity. The overall score will be between 0 and 8 with higher scores indicating greater functional independence. | From randomisation until day 90 |
| Instrumental activities of daily living at day 180 | Measured using the Lawton Instrumental Activities of Daily Living Scale. Eight categories of daily activities are asked, and the participant is scored for each category with either a 0 or a 1 based on the highest functional level for each activity. The overall score will be between 0 and 8 with higher scores indicating greater functional independence. | From randomisation until day 180 |
| Anxiety and Depression at day 180 | Measured using the Hospital Anxiety and Depression scale (HADs) which is a 14 item scale that consists of two seven item sub-scales; seven questions for anxiety and seven questions for depression. The scale is measured with each item measured on a four point Likert scale (0 to 3). The higher the score indicating the greater the severity. | From randomisation until Day 180 outcome assessment is completed. |
| Participant cognition at day 180 | Measured using the Montreal Cognitive Assessment Blind (MOCA-Blind) | At day 180 from randomisation |
| Post traumatic stress disorder at day 180 | Measured using the Impact of Events Scale 6 Items that consists of 6 questions all measured on a 5-point Likert scale from 0 to 4 with the higher the score indicating greater severity. 0 - Not at all; 1 - A little bit; 2 - Moderately; 3 - Quite a bit; 4 - Extremely | Measured at Day 180 after randomisation |
| Cost-effectiveness of the intervention at day 180 | The primary cost-effectiveness analysis will be conducted from the Australian healthcare payer's perspective using an analytical time horizon of 6-months. Post discharge costs will be determined using patient-level data linkage to determine long-term health care use (including readmission to hospital and emergency department presentation). Quality-adjusted life years (QALYs) will be calculated using information from the Euroqol 5-dimension 5 level (EQ-5D-5L) assessed at day 180 post randomisation, combined with information on vital status. We will calculate incremental cost-effectiveness ratios, including the cost per additional QALY for the intervention versus standard care. To increase the robustness of the sampling, we will use non-parametric bootstrapping with unrestricted random sampling to produce cost and effectiveness replications, and confidence intervals for the cost-effectiveness ratios. | From randomisation until Day 180. |
References
Clinical Trials Gov: Improving Survivorship for Critically Ill Patients Aged 65 and OverOther trials to consider
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