Improving Survivorship for Critically Ill Patients Aged 65 and Over
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorAustralian and New Zealand Intensive Care Research Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Multicomponent telehealth care coordination
Other interventionParticipants 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Control: Standard careNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From randomisation until 90 days post randomisation.Secondary outcomes
1
All-cause mortality to day 180
Time frame
From randomisation until Day 180 outcome assessment is completed.2
Avoidable acute hospital readmissions to day 90
Measured by reviewing the number of emergency admissions to hospital participants had between randomisation and day 90.
Time frame
From randomisation until day 90 post randomisation3
Patient Activation Measure (PAM) at day 90
Time frame
From randomisation until Day 90 post randomisation.4
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).
Time frame
From randomisation until Day 90 outcome assessment is completed.Sponsors and contacts
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Source ClinicalTrials.gov
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