Improving Survivorship for Critically Ill Patients Aged 65 and Over

NCT ID: NCT07175961

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-02-29

Brief 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 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.

Conditions

Critical Illness; Recovery Outcomes; Care Coordination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control: Standard care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Participants randomised into this group will receive tailored care coordination and support to develop recovery goals post hospital discharge.

Group Type: EXPERIMENTAL

Multicomponent telehealth care coordination

Intervention Type: OTHER

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.

Interventions

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 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Australian and New Zealand Intensive Care Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol Hodgson, Professor

Role: STUDY_CHAIR

Monash University

Locations

Cabrini Hospital Malvern

Melbourne, Victoria, Australia

Monash Health

Melbourne, Victoria, Australia

Countries

Australia

Central Contacts

Anne Mather

Role: CONTACT

anne.mather@monash.edu

+61 3 9903 0263

Tony Trapani

Role: CONTACT

tony.trapani@monash.edu

+61 3 9903 0343

Facility Contacts

Lisa Hodgson, Dougherty

Role: primary

icuresearch@cabrini.com.au

+61 3 9508 1744

Michelle Paton

Role: primary

michelle.paton@monashhealth.org

+61 3 9594 6666

Other Identifiers

ANZIC-RC/CH007

Identifier Type: -

Identifier Source: org_study_id