Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000737831
Ethics application status
Approved
Date submitted
14/04/2021
Date registered
11/06/2021
Date last updated
5/10/2022
Date data sharing statement initially provided
11/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Virtual Peer Support for ICU Survivors: icuRESOLVE-D (Intensive Care Unit REcovery Solutions cO-Led through surVivor Engagement Digital) Study
Scientific title
Feasibility of Virtual Peer Support for ICU Survivors: icuRESOLVE-D (Intensive Care Unit REcovery Solutions cO-Led through surVivor Engagement Digital) Study
Secondary ID [1] 303948 0
Nil known
Universal Trial Number (UTN)
Trial acronym
icuRESOLVE-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 321543 0
Post Intensive Care Syndrome 321544 0
Condition category
Condition code
Mental Health 319292 319292 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 319293 319293 0 0
Other physical medicine / rehabilitation
Public Health 319675 319675 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TIDieR checklist
Brief name: Virtual facilitated peer support group

Rationale:
Physical, cognitive, emotional, financial and social problems are quite common among survivors (patients and families). This is recognised as Post Intensive Care Syndrome. When survivors leave ICU, they are required to navigate increasingly complex health systems and reintegrate with their communities, while trying to make sense of their experiences and possible new impairments. This occurs at a time when they may be most vulnerable with potentially little support from the health system. Currently in Australia, ICU survivors receive little to no follow-up. Peer support has potential to address some of these challenges and system deficiencies and is relatively unexplored in critical care. Access to peer support groups can limit their effectiveness, access to virtual peer support groups may improve this.

Materials:
Upon recruitment, participants will receive an information letter outlining details of the icuRESOLVE-D Peer Support Program and a patient and carer information booklet designed for this study, outlining the potential effects of post-intensive care syndrome, the impact of an ICU stay, information for patients post-hospital and general post-ICU health advice.
Reminder letter posted to their postal address with dates/times of the Peer Support Sessions prior to each session, Reminder text message within the week preceding each Peer Support Session

Intervention Delivery - Each Peer Support Session will be delivered by a clinician/s with ICU and group facilitation experience (e.g. Social Worker, Psychologist). Sessions will incorporate a short talk/presentation on a relevant topic to ICU recovery.

Facilitators: Facilitators will all be registered clinicians in their speciality field of practice (Social Work and/or Psychology) and group facilitation is part of their scope of practice. These staff members are co-investigators of the project. The Project Manager is senior intensive care physiotherapist with expertise in follow-up of intensive care survivors and is skilled in debriefing (a method used in simulation training which has transferable skills to group facilitation).

Procedure:
The icuRESOLVE Peer Support Program (developed in Phase 1) that will form the intervention:

Format: Virtual, group based

Duration of Program: 4 sessions, fortnightly over 8 weeks. The program will run as a rolling/continuous program so that participants can commence the program upon recruitment in to the study

Location: Virtual, using Zoom platform. If patients do not have access to a webcam/computer they will be able to call into the group using their phone.

Time: 12pm-1pm

Session Length: 1 hour

Facilitator: A clinician with ICU and group facilitation experience. E.g. Social worker, psychologist.

Format:
1. Welcome to group (group facilitators)
2. Formal talk (led by guest speaker) on a relevant topic
3. Facilitated small group discussion in break-out rooms including virtual tea break (led by group facilitators)
4. Formal group reflection (led by group facilitators)
5. Close of session (group facilitators)


Topics and guest speakers:
1. Social issues post-ICU – Social Worker
2. What happens in the ICU – ICU Consultant
3. Physical recovery post-ICU – Physiotherapist
4. Coping and psychological recovery - Psychologist

Infrastructure: - icuRESOLVE Session Invite Letter Reminder letters and text messages for upcoming sessions, attendance: RSVP via phone/text. The group may setup a Facebook page/group.

Enabling Activities: Prior to each icuRESOLVE Peer Support Program Session, a session plan and overview will be developed by the icuRESOLVE Project Lead and circulated amongst the icuRESOLVE facilitators.

Attendance: Attendance and adherence to the protocol will be documented in Attendance sheet.

Who provided:
icuRESOLVE Project Lead: An experienced ICU Clinician with expertise in project management, debriefing and consumer engagement

icuRESOLVE Session Facilitator: An experienced ICU Clinician with expertise in group facilitation. Facilitators will all be registered clinicians in their speciality field of practice (Social Work and/or Psychology) and group facilitation is part of their scope of practice. These staff members are co-investigators of the project. The Project Manager is senior intensive care physiotherapist with expertise in follow-up of intensive care survivors and is skilled in debriefing (a method used in simulation training which has transferrable skills to group facilitation).

Guest Speakers: Social worker, Psychologist, Physiotherapist, ICU Consultant.

Mode of delivery:
The icuRESOLVE Peer Support Program will be delivered virtually via Zoom, in a group setting. Participants will be provided with instructions for how to join Zoom

Location:
The icuRESOLVE Peer Support Program will be delivered virtually, so participants can access the program from their own home. Participants will need access to a tablet or computer with a webcam and internet or telephone.

Frequency and duration:
The icuRESOLVE Peer Support Program will be run fortnightly over a 8-week period. A total of 4 sessions will be offered to each participant. Sessions will be 1 hour in duration. This will be a rolling program.

Tailoring:
The icuRESOLVE Peer Support Program was initially developed using co-design so has had extensive consumer review and feedback regarding the design. To support ongoing consumer engagement in design – we will incorporate any feedback received from the first 5 participants to complete the program via the barriers/enablers interview.
Intervention code [1] 320256 0
Treatment: Other
Intervention code [2] 320576 0
Rehabilitation
Intervention code [3] 320577 0
Behaviour
Comparator / control treatment
Control: Standard care - no formal specialised follow up post-intensive care discharge, no peer support program
Control group
Active

Outcomes
Primary outcome [1] 327174 0
The composite primary outcome is feasibility assessed by comparison of observed frequencies to a priori-specified targets by audit of study records, for:
• Informed consent among eligible patients (60% of eligible participants approached).
• Retention until outcome assessment (70%).
• Among participants who neither dropped out nor died - completion of outcome measures (60%) and completion of 75% of intervention sessions (50%).
• Reasons for participant non-attendance.
• Reasons for any limitations in delivering the virtual intervention (for example, participant connectivity and technological limitations).
• Satisfaction survey and barriers/enablers to the intervention (intervention group only).
• Length of time to complete outcome measures.
Timepoint [1] 327174 0
Initial baseline outcome measures will be conducted over the phone at one week following discharge home. Follow up outcome assessments will be conducted over the phone at close to 5 months post discharge home.
Secondary outcome [1] 394060 0
World Health Organization’s Disability Assessment Schedule, WHODAS 2.0, 12 item
Timepoint [1] 394060 0
Initial baseline outcome measures will be conducted over the phone at one week following discharge home. Follow up outcome assessments will be conducted over the phone at close to 5 months post discharge home.
Secondary outcome [2] 394061 0
Hospital Anxiety and Depression Scale (HADS).
Timepoint [2] 394061 0
Initial baseline outcome measures will be conducted over the phone at one week following discharge home. Follow up outcome assessments will be conducted over the phone at close to 5 months post discharge home.
Secondary outcome [3] 394062 0
Quality of Life – EQ-5D-5L
Timepoint [3] 394062 0
Initial baseline outcome measures will be conducted over the phone at one week following discharge home. Follow up outcome assessments will be conducted over the phone at close to 5 months post discharge home.

Eligibility
Key inclusion criteria
Patients and their families will be screened on discharge from ICU and will be eligible based on the term ‘ICU survivor’ (incorporating both) and if they meet the following inclusion criteria:
Patients:
• ICU admission >48 hours at participating hospital
• Age >18 years
• Access to virtual platform (functioning computer, internet access and speed, capacity to log onto a video-sharing platform)
• Living in the community
• Discharged from ICU within past 3 years
Carer:
• Living in the same household as patient, or identified as primary carer
• Age >18 years
• Access to virtual 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
• Not expected to survive to hospital discharge
• Bereaved family members
• Pre-existing cognitive conditions (e.g. dementia) impacting ability to participate in intervention and/or complete outcome measures
• Referred or transferred to the Psychiatric Services during the hospitalisation period as identified in medical file e.g. post-attempted suicide
• Pre-existing severe neurological conditions
• Not expected to return home following discharge
• Unable to communicate in English
• Any other reason preventing participants from participating in intervention

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 by opaque envelopes Participants and investigators involved in the virtual peer support group facilitation will not be blinded to group allocation, assessors will be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients and carers will be randomized as dyads to the intervention (virtual peer support) or usual care (no post-ICU care) using a stratified randomisation allocation method to ensure patients and their carers remain in the same group, and to aim for equal number of dyads in each group. Randomization will be computer generated using RedCap and completed after recruitment by a blinded associate investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot trial, the sample size will be one of convenience determined in the absence of previous research on which to base a sample size and with no specific sample size required for pilot studies. The data obtained will be used to power for subsequent large randomised controlled trials.
We aim to recruit a total of 20 participants to the intervention group (peer support) and a total of 20 participants to the control group (standard care), resulting in a total sample size of 40. From our prior research, it is anticipated that approximately 30% of recruited patients will have a family member / carer who will also consent to participate. As such, it is anticipated that of total sample size of 40, approximately 30 will be patients and 10 will be carer/family participants.
Data analysis will be as randomized. Planned sub-group analyses will be conducted based on the whether they are a patient or carer. Intervention effect sizes will be calculated to inform the power calculation of subsequent adequately powered trials.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/06/2021
Actual
27/07/2021
Date of last participant enrolment
Anticipated
3/12/2021
Actual
25/03/2022
Date of last data collection
Anticipated
1/04/2022
Actual
30/05/2022
Sample size
Target
40
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19095 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 19097 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 19098 0
Footscray Hospital - Footscray
Recruitment postcode(s) [1] 33653 0
3050 - Parkville
Recruitment postcode(s) [2] 33655 0
3021 - St Albans
Recruitment postcode(s) [3] 33656 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 308331 0
Charities/Societies/Foundations
Name [1] 308331 0
Society of Critical Care Medicine
Country [1] 308331 0
United States of America
Primary sponsor type
Individual
Name
A/Prof Kimberley Haines
Address
Physiotherapy Research Lead
Physiotherapy Department
Western Health
Sunshine Hospital
176 Furlong Rd
St Albans
Victoria 3021
Australia
Country
Australia
Secondary sponsor category [1] 309143 0
None
Name [1] 309143 0
Address [1] 309143 0
Country [1] 309143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308307 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 308307 0
Ethics committee country [1] 308307 0
Australia
Date submitted for ethics approval [1] 308307 0
23/02/2021
Approval date [1] 308307 0
06/04/2021
Ethics approval number [1] 308307 0
HREC/73171/MH-2021

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

Contacts
Principal investigator
Name 110246 0
A/Prof Kimberley Haines
Address 110246 0
Physiotherapy Department
Sunshine Hospital
176 Furlong Rd
St Albans
Victoria 3021
Country 110246 0
Australia
Phone 110246 0
+61 466417689
Fax 110246 0
Email 110246 0
[email protected]
Contact person for public queries
Name 110247 0
Kimberley Haines
Address 110247 0
Physiotherapy Department
Sunshine Hospital
176 Furlong Rd
St Albans
Victoria 3021
Country 110247 0
Australia
Phone 110247 0
+61 466417689
Fax 110247 0
Email 110247 0
[email protected]
Contact person for scientific queries
Name 110248 0
Kimberley Haines
Address 110248 0
Physiotherapy Department
Sunshine Hospital
176 Furlong Rd
St Albans
Victoria 3021
Country 110248 0
Australia
Phone 110248 0
+61 466417689
Fax 110248 0
Email 110248 0
[email protected]

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


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.