Critical IllnessPhase 3IMPROVE-65NCT07175961
Improving Survivorship for Critically Ill Patients Aged 65 and Over
A Phase 3 study testing Multicomponent telehealth care coordination in people with Critical Illness and Recovery Outcomes, run by Australian and New Zealand Intensive Care Research Centre at 2 sites in Australia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Critical Illness, Recovery Outcomes, Care Coordination
- What is being tested?
- Multicomponent telehealth care coordination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesAustralia
- Study dates
- Nov 2025to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites
Cabrini Hospital Malvern
Melbourne, Victoria, 3144
Lisa Hodgson, Dougherty, +61 3 9508 1744, icuresearch@cabrini.com.au
Monash Health
Melbourne, Victoria, 3168
Michelle Paton, +61 3 9594 6666, michelle.paton@monashhealth.org
About this study
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.
Read the 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.
- Conditions
- Critical Illness, Recovery Outcomes, Care Coordination
- Being tested
- Multicomponent telehealth care coordination
- Keywords
- critical illness, recovery coordination, patient reported outcomes
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent telehealth care coordinationOther
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 recovery goals and assess recovery goals and navigator further primary care support if required. Participants will also be called at Day 90 and 180 by outcome assessors to collected patient reported outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Control: Standard care | No intervention | Paticipants randomised to the control group will not receive the intervention. They will be contacted by the study team to collect data on access to primary health care services post hospital discharge and will be contacted at D90 and D180 by outcome assessors to collected patient reported outcomes. |
| Intervention | Experimental | Participants randomised into this group will receive tailored care coordination and support to develop recovery goals post hospital discharge. Receives: Other: Multicomponent telehealth care coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomisation until 90 days post randomisation.
Secondary outcomes (17)
All-cause mortality to day 180
Measured: 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.
Measured: From randomisation until day 90 post randomisation
Patient Activation Measure (PAM) at day 90
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomisation until Day 180 outcome assessment is completed.
Participant cognition at day 180
Measured using the Montreal Cognitive Assessment Blind (MOCA-Blind)
Measured: 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: 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.
Measured: From randomisation until Day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol Hodgson, Professor, Study chair, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175961
- Sponsor's protocol ID
- ANZIC-RC/CH007
- Acronym
- IMPROVE-65
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of the study, the study management committee will consider requests from researchers who provide a methodologically sound scientific proposal as per the Data Sharing Policy set out in the ANZIC Research Centre Terms of Reference.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Survivorship for Critically Ill Patients Aged 65 and Over
- ClinicalTrials.gov ID
- NCT07175961
- Acronym / sponsor ID
- IMPROVE-65 / ANZIC-RC/CH007
- Conditions
- Critical Illness, Recovery Outcomes, Care Coordination
- Keywords
- critical illness, recovery coordination, patient reported outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Standard care | No intervention | –Paticipants randomised to the control group will not receive the intervention. They will be contacted by the study team to collect data on access to primary health care services post hospital discharge and will be contacted at D90 and D180 by outcome assessors to collected patient reported outcomes. |
| Intervention | Experimental | Other: Multicomponent telehealth care coordinationParticipants randomised into this group will receive tailored care coordination and support to develop recovery goals post hospital discharge. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent telehealth care coordinationParticipants 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 recovery goals and assess recovery goals and navigator further primary care support if required. Participants will also be called at Day 90 and 180 by outcome assessors to collected patient reported outcomes. | Other | Intervention |
Primary outcome
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.
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.
17 secondary outcomes
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
Instrumental activities of daily living at day 180
Time frame: From randomisation until day 180
Anxiety and Depression at day 180
Time frame: From randomisation until Day 180 outcome assessment is completed.
Participant cognition at day 180
Time frame: At day 180 from randomisation
Post traumatic stress disorder at day 180
Time frame: Measured at Day 180 after randomisation
Cost-effectiveness of the intervention at day 180
Time frame: From randomisation until Day 180.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Yes. At the conclusion of the study, the study management committee will consider requests from researchers who provide a methodologically sound scientific proposal as per the Data Sharing Policy set out in the ANZIC Research Centre Terms of Reference.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carol Hodgson, Professor study chair
Monash University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multicomponent telehealth care coordination in people with Critical Illness and Recovery Outcomes, run by Australian and New Zealand Intensive Care Research Centre at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Mather (+61 3 9903 0263, anne.mather@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.