Improving Survivorship for Critically Ill Patients Aged 65 and Over

NCT07175961 | Not Yet Recruiting Phase 3

• 1 other identifier: ANZIC-RC/CH007
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Illness; Recovery Outcomes; Care Coordination

Keywords

critical illness; recovery coordination; patient reported outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

Study Arms (2)

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.

Other: Multicomponent telehealth care coordination

Interventions

Multicomponent telehealth care coordination 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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead

Study Sites (2)

Cabrini Hospital Malvern

Melbourne, Victoria, 3144, Australia

Location

Monash Health

Melbourne, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carol Hodgson, Professor

  Monash University

  STUDY CHAIR

Central Study Contacts

Anne Mather

CONTACT

+61 3 9903 0263; anne.mather@monash.edu

Tony Trapani

CONTACT

+61 3 9903 0343; tony.trapani@monash.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 16, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (2)