Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000267550
Ethics application status
Approved
Date submitted
2/02/2024
Date registered
15/03/2024
Date last updated
30/08/2024
Date data sharing statement initially provided
15/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a Digital Peer Support Intervention for ICU Survivors on Health Related Quality of Life: icuRESOLVE (icu Recovery Solutions Co-Designed through SurVivor Engagement) Randomised Controlled Trial
Scientific title
Effect of a Digital Peer Support Intervention for ICU Survivors on Health-Related Quality of Life: icuRESOLVE (icu Recovery Solutions Co-Designed through SurVivor Engagement) Randomised Controlled Trial
Secondary ID [1] 311461 0
None
Universal Trial Number (UTN)
Trial acronym
icuRESOLVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 332762 0
Post Intensive Care Syndrome 332763 0
Condition category
Condition code
Mental Health 329481 329481 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 329482 329482 0 0
Other physical medicine / rehabilitation
Public Health 329483 329483 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group (peer support + recovery booklet):
Additional to standard care (Intervention) summarized here:
What? Digital, facilitated peer support group. Two components:
1) Educational/informational exchange delivered by staff on common problems faced after ICU
2) Group/peer to peer discussion of shared experiences and pragmatic solutions
The formal component is education delivered by expert clinicians, at the participant pace with time for questions from participants. This education is delivered via powerpoint using the Zoom screen-share function. The informal component includes facilitated peer-to-peer discussion to share experiences and support social cohesion, led by a social worker or psychologist skilled in-group facilitation.
When? 1x fortnight, starting at 6-8 weeks post-hospital discharge
Where? Online, via Zoom platform
For how long? 1-hour session total (30 minutes formal introduction + 30 minutes facilitated peer support), for a total of 4 topics, fortnightly across 8 weeks.
The digital peer support program will be an ongoing ‘rolling’ program, with sessions held every 2 weeks - so participants will enter program at one topic, and keep attending until all four topics completed, then exit program.
Participants will also be provided with an education booklet, which was co-designed and has undergone extensive consumer engagement. The consumer engagement process included stakeholder input from ICU patients, ICU caregivers, ICU clinicians and researchers to develop the comprehensive booklet to support the recovery process. The content was developed by expert clinician presenters and the project team, and then sent to patient and caregivers for feedback using an iterative process, over a fortnight. The initial experienced based co-design methodology used to develop the peer support program occurred using stakeholder consumer input over three 2 hour workshops over a one month period, the information generated through this process was incorporated into this document. The feedback sought during the pilot trial from participants was also included in the development process for this booklet. The booklet contains patient and carer focused information that explains some of the potential impacts of critical illness on their health (e.g. post-intensive care syndrome), and where to seek support following hospital discharge, has a section on goal-setting and useful information that can be shared with their general practitioner.
Intervention adherence for this group will be monitored with an attendance log, completed by peer support facilitators each session.
Intervention code [1] 327909 0
Treatment: Other
Comparator / control treatment
Standard care: Patients currently do not receive any formal specialised ICU follow-up care post-hospital discharge, nor specialised recovery-based information. Standard care does involve referral to various community service providers at the discretion of community care providers, for example referral to outpatient physiotherapy or psychology from the patient's general practitioner.
Control group
Active

Outcomes
Primary outcome [1] 337289 0
Health-related quality of life
Timepoint [1] 337289 0
Baseline: 4-8 weeks post-hospital discharge
Two follow-up time points of 14-18 weeks and 26-28 weeks post-hospital discharge
Secondary outcome [1] 431341 0
Self-reported health status
Timepoint [1] 431341 0
Baseline: 4-8 weeks post-hospital discharge
Two follow-up time points of 14-18 weeks and 26-28 weeks post-hospital discharge
Secondary outcome [2] 431342 0
Post-traumatic stress disorder
Timepoint [2] 431342 0
Baseline: 4-8 weeks post-hospital discharge
Two follow-up time points of 14-18 weeks and 26-28 weeks post-hospital discharge
Secondary outcome [3] 431343 0
Social Isolation
Timepoint [3] 431343 0
Baseline: 4-8 weeks post-hospital discharge
Two follow-up time points of 14-18 weeks and 26-28 weeks post-hospital discharge
Secondary outcome [4] 431344 0
Resilience
Timepoint [4] 431344 0
Baseline: 4-8 weeks post-hospital discharge
Two follow-up time points of 14-18 weeks and 26-28 weeks post-hospital discharge
Secondary outcome [5] 432222 0
Quality of Life
Timepoint [5] 432222 0
Baseline: 4-8 weeks post-hospital discharge
Two follow-up time points of 14-18 weeks and 26-28 weeks post-hospital discharge
Secondary outcome [6] 439240 0
Patient activation
Timepoint [6] 439240 0
Secondary outcome [7] 439241 0
Patient activation
Timepoint [7] 439241 0
Baseline: 4-8 weeks post-hospital discharge Two follow-up time points of 14-18 weeks and 26-28 weeks post-hospital discharge
Secondary outcome [8] 439242 0
Intervention Adherence (Intervention group only)
Timepoint [8] 439242 0
Baseline: 4-8 weeks post-hospital discharge Two follow-up time points of 14-18 weeks and 26-28 weeks post-hospital discharge
Secondary outcome [9] 439243 0
Intervention Adherence (Intervention group only)
Timepoint [9] 439243 0
At conclusion of final intervention session (intervention group only)

Eligibility
Key inclusion criteria
• ICU admission >48 hours at participating hospital
• Age 18 years and over
• Access to digital platform (functioning computer, internet access and speed, capacity to log onto a video-sharing platform)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Death anticipated as likely prior to day 90/180 outcome assessment
• Deemed high risk of loss to follow up by research staff.
• Diagnosed pre-existing or new cognitive conditions that would prevent ability to participate in the intervention or outcome assessment.
• Referred or transferred to the Psychiatric Services during the hospitalisation period as identified in medical file
• Severe neurological conditions (e.g. severe traumatic brain injury) that would prevent ability to participate in the intervention or outcome assessment.
• Not expected to return home following discharge
• Lack of either a reliable smartphone with a data plan or internet or a computer with internet, webcam and microphone access; or phone access
• Unable to effectively communicate in English, and that would prevent ability to participate in the intervention or outcome assessment
• Any other reason preventing participants from participating in intervention, including but not limited to: known criminal activity, known personality disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed and centralised via a REDCap database. Investigators will become aware of allocation after verbal consent is received, in order to provide adequate notice to intervention participants regarding the timing of the next intervention session to support their attendance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will generate a randomisation sequence and randomisation will be administered via a web-based system. Participants will be randomised (1:1) to receive either Intervention Group or Comparator Group .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two sample sizes have been calculated for 80% power and 90% power for the primary outcome measure, as recruitment will be contingent on the outcome of grant funding and potential to recruit to the sample size required for 90% power - if a current grant application is successful.

For an 80% power and a two-sided significance level of 0.05 a sample size of 158 survivors (79 in each group) is required. For a 90% power and a two-sided significance level of 0.05 a sample size of 212 survivors (106 in each group) is required. These sample sizes are needed to provide 80% and 90% power respectively to detect a minimal clinically important difference of 8 units (in a comparable population as not established in critical care) in the EQ-5D-5L visual analogue scale at 90-days comparing intervention group to standard care, and a two-sided significance level of 0.05. This is based on a standard deviation of 16.57, allows for 15% loss to follow-up at day 90, and accounts for a conservative correlation of 0.1 between EQ-5D-5L at baseline and 90-days.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2024
Actual
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,VIC
Recruitment hospital [1] 26136 0
Footscray Hospital - Footscray
Recruitment hospital [2] 26137 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 26138 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 26139 0
Eastern Health - Box Hill
Recruitment hospital [5] 26140 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [6] 26141 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [7] 26142 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 41995 0
3011 - Footscray
Recruitment postcode(s) [2] 41996 0
3021 - St Albans
Recruitment postcode(s) [3] 41997 0
3084 - Heidelberg
Recruitment postcode(s) [4] 41998 0
3128 - Box Hill
Recruitment postcode(s) [5] 41999 0
3550 - Bendigo
Recruitment postcode(s) [6] 42000 0
3050 - Parkville
Recruitment postcode(s) [7] 42001 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 315742 0
Self funded/Unfunded
Name [1] 315742 0
A/Prof Kimberley Haines
Country [1] 315742 0
Australia
Primary sponsor type
University
Name
Department of Critical Care, The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 317856 0
None
Name [1] 317856 0
Address [1] 317856 0
Country [1] 317856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314605 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 314605 0
Ethics committee country [1] 314605 0
Australia
Date submitted for ethics approval [1] 314605 0
18/09/2023
Approval date [1] 314605 0
05/03/2024
Ethics approval number [1] 314605 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132154 0
A/Prof Kimberley Haines
Address 132154 0
Sunshine Hospital, Furlong Road, St Albans, Victoria 3021
Country 132154 0
Australia
Phone 132154 0
+61 466417689
Fax 132154 0
Email 132154 0
Kimberley.Haines@wh.org.au
Contact person for public queries
Name 132155 0
Kimberley Haines
Address 132155 0
Sunshine Hospital, Furlong Road, St Albans, Victoria 3021
Country 132155 0
Australia
Phone 132155 0
+61 466417689
Fax 132155 0
Email 132155 0
Kimberley.Haines@wh.org.au
Contact person for scientific queries
Name 132156 0
Kimberley Haines
Address 132156 0
Sunshine Hospital, Furlong Road, St Albans, Victoria 3021
Country 132156 0
Australia
Phone 132156 0
+61 466417689
Fax 132156 0
Email 132156 0
Kimberley.Haines@wh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.