Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000615280
Ethics application status
Approved
Date submitted
11/04/2018
Date registered
20/04/2018
Date last updated
12/10/2022
Date data sharing statement initially provided
12/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a Peer Support Program for Intensive Care Unit Survivors to improve Psychological Recovery - Pilot Randomized Controlled Trial
Scientific title
icuRESOLVE (Intensive Care Unit REcovery Solutions cO-Led through surVivor Engagement): Co-designing Peer Support With ICU Survivors - Phase 2 Pilot Randomized Controlled Trial
Secondary ID [1] 294568 0
Nil known
Universal Trial Number (UTN)
U1111-1212-2416
Trial acronym
icuRESOLVE Phase 2
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 307352 0
Patient and family reported psychological outcomes 307353 0
Condition category
Condition code
Mental Health 306459 306459 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 306460 306460 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TIDieR criteria Study Intervention
Item 1. Brief name: Provide the name or a phrase that describes the intervention: In-person, facilitated peer support group

Item 2. Why: Describe any rationale, theory, or goal of the elements essential to the intervention: 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.

Item 3. What (materials): Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers: Participants randomised to the intervention group will receive the following informational materials:

* Upon recruitment, participants will receive an information letter outlining details of the icuRESOLVE Peer Support Program, including: What is Post Intensive Care Syndrome (PICS), How does it affect me and my family/carer, What is Peer Support, When are the Peer Support Sessions and what does attendance involve.

* 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 by a clinician on a relevant topic to ICU survival. E.g. What is PICS, Coping, Adjustment & Self Care...

* 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 highly skilled in debriefing (a method used in simulation training which has transferrable skills to group facilitation).

Item 4. What (procedures): Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities: The icuRESOLVE Peer Support Program (developed via co-design methodology in Phase 1) informs the intervention in Phase 2:

Format: Face to face, group based.
Duration of Program: 6 sessions, fortnightly over 12 weeks. The program will run as a rolling/continuous program so that participants can commence the program upon recruitment in to the study
Location: A non clinical room at the hospital site with space for 20 participants including chairs, tables and access to bathrooms, tea/coffee, accessible for people with disability
Time: Alternating mornings and afternoons e.g. 10am-12pm; 12-2pm
Session Length: 2 hours
Facilitator: A clinician with ICU and group facilitation experience. E.g. Social worker, psychologist.
Example Format:
- 1st hour: Formal: a short talk on a relevant topic followed by facilitated group discussion with survivors sharing their stories. The group may also work on tasks (e.g. developing information sheets for the ICU waiting room). The group takes ownership of the content of future meetings.
- Tea/Coffee break including a light snack (e.g. biscuits)
- 2nd hour: Informal, non-facilitated conversation / discussion amongst group members

Guest Speakers: Examples include: What is PICS, Physiotherapist, Psychologist, Clinician Stories, Occupational Therapist, HARP, Social Worker. The group will identify the topics for future sessions and the icuRESOLVE Project Officer will identify Professionals to deliver the content at subsequent sessions.

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 for each participant will be documented on an attendance log.

Item 5. Who provided: For each category of intervention provider (for example, psychologist, nursing assistant), describe their expertise, background and any specific training given. icuRESOLVE Project Lead: An experienced ICU Physiotherapist 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 highly skilled in debriefing (a method used in simulation training which has transferrable skills to group facilitation).

icuRESOLVE Guest Speakers: Speakers will be expert clinicians - for example, Social Workers with experience working with ICU Survivors and their carers, ICU Consultants with expertise in management of ICU patients.

Item 6. How: Describe the modes of delivery (such as face to face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group. The icuRESOLVE Peer Support Program will be delivered face-to-face in a group setting.

Item 7. Where: Describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features: The icuRESOLVE Peer Support Program will be delivered in a non-clinical room within the hospital setting. The room will have tables and chairs for 20 people. Additional rooms will be booked if the group size is anticipated to be greater than 20 to break the group in to smaller sizes if required to enable participants to more easily hear each other and interact.

Item 8. When and how much: Describe the number of times the intervention was delivered and over what period of time including the number of sessions, their schedule, and their duration, intensity or dose: The icuRESOLVE Peer Support Program will be run fortnightly over a 12-week period. A total of 6 sessions will be offered to each participant. Sessions will be 2 hours in duration. The Program is a rolling program so participants can commence attending following their discharge home.

Item 9. Tailoring: If the intervention was planned to be personalised, titrated or adapted, then describe what, why, when, and how: The icuRESOLVE Peer Support Program was developed using co-design methodology. To enable on-going consumer involvement in the peer support program, session content will in part be determined by the participants. Phase 1 identified the importance of ownership of the program by participants to enable to sessions to be tailored to their needs to improve engagement and attendance.

Item 10. Modifications: If the intervention was modified during the course of the study, describe the changes (what, why, when, and how). N/A

Item 11. How well (planned): If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them: N/A

Item 12: How well (actual): If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned: N/A
Intervention code [1] 300864 0
Treatment: Other
Comparator / control treatment
Control: Standard care (no peer support).
Control group
Active

Outcomes
Primary outcome [1] 305468 0
Feasibility of implementing the peer support model as measured by the following uptake, participant satisfaction and process measures:
• Percentage of participants who agreed to participate of those who were approached for recruitment
• Percentage of participants who agreed to participate when approached by a) in-person approach vs. b) phone approach only (if unable to recruit in-person).
• Attendance rate of participants in the intervention group (e.g. percentage who attended more than half of the six sessions, percentage who attended less than half of the session and reasons unable to attend).
• ICU survivors satisfaction survey of the intervention (intervention group only) - questionnaire developed by the researchers
• Percentage of participants who completed pre and post outcome measures (both groups)
Timepoint [1] 305468 0
17-20 weeks post hospital discharge
T
Secondary outcome [1] 345348 0
Post-traumatic growth - Post-Traumatic Growth Inventory
Timepoint [1] 345348 0
Assessed participants at 3-4 weeks post acute hospital discharge and post outcome measures completed at 17 to 20 weeks post acute hospital discharge
Secondary outcome [2] 345349 0
Change in Resilience - Connor Davidson Resilience Scale (CD-RISC)
Timepoint [2] 345349 0
Assessed participants at 3-4 weeks post acute hospital discharge and post outcome measures completed at 17 to 20 weeks post acute hospital discharge
Secondary outcome [3] 345350 0
Social support - PROMIS Inventory respectively (Social Isolation, Informational Support and Emotional Support from the PROMIS inventory)
Timepoint [3] 345350 0
Assessed participants at 3-4 weeks post acute hospital discharge and post outcome measures completed at 17 to 20 weeks post acute hospital discharge
Secondary outcome [4] 345351 0
Anxiety and Depression - measured using HADS
Timepoint [4] 345351 0
Assessed participants at 3-4 weeks post acute hospital discharge and post outcome measures completed at 17 to 20 weeks post acute hospital discharge.
Secondary outcome [5] 345352 0
Post-traumatic stress disorder - measured using IES-R
Timepoint [5] 345352 0
Assessed participants at 3-4 weeks post acute hospital discharge and post outcome measures completed at 17 to 20 weeks post acute hospital discharge
Secondary outcome [6] 345353 0
Quality of Life – measured using EQ-5D-5L
Timepoint [6] 345353 0
Assessed participants at 3-4 weeks post acute hospital discharge and post outcome measures completed at 17 to 20 weeks post acute hospital discharge

Eligibility
Key inclusion criteria
ICU survivors:
• ICU admission at Sunshine hospital
• Age >18 years
• Able to speak and understand English
• Able to receive and participate in phone surveys
• Living in the community

Carer/Family Members
• Age >18 years
• Able to speak and understand English
• Able to receive and participate in phone surveys
• Living in the community
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Imminent death
• Bereaved family members
• Pre-existing or new cognitive conditions
• Pre-existing or new psychiatric conditions
• Severe neurological conditions
• Not expected to return home following discharge
• Discharge to a destination that would prohibit in-person group attendance (e.g.
interstate or >100km from the health service

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)
Opaque envelopes will be used to conceal allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized to Intervention (Peer Support Group) or Control (Standard Care – no Peer Support Group) using a 1:1 allocation method and using computer-generated random numbers from www.randomization.com.
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 30 participants to the intervention group (peer support) and a total of 30 participants to the control group (standard care), resulting in a total sample size of 60. From Phase 1 participant recruitment data, it is anticipated that approximately 50% 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 60, 40 will be patients and 20 will be carer/family participants.

A total 20 carer/family participants should result in 10 per group (intervention and control), which is a generally accepted minimum to calculate variance.

Data analysis will be as randomized. Planned sub-group analyses will be conducted based on the whether they are a patient or family member. Intervention effect sizes will be calculated to inform the power calculation of subsequent adequately powered trials.

No formal power calculation is required as this is a pilot study aiming to calculate power to determine effect in a future larger, multi-site RCT.

Feasibility will be described in numbers and percentages. Continuous variables will be reported as mean and standard deviation (SD), or median and interquartile range [IQR] depending on data distribution.

Effect sizes for all secondary outcomes will be calculated and interpreted within-group (from baseline to follow-up) and between-group (follow-up) according to Cohen, where applicable (0.4 or less = small; 0.5 = moderate and 0.8 = large). Sample sizes for a future trial will be estimated using G*Power (Version 3.1.9.2, Universitat Dusseldorf, Dusseldorf, Germany).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/04/2018
Actual
25/04/2018
Date of last participant enrolment
Anticipated
26/11/2018
Actual
17/12/2020
Date of last data collection
Anticipated
25/03/2019
Actual
21/04/2021
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10627 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 23364 0
Western Hospital - Footscray - Footscray
Recruitment postcode(s) [1] 22345 0
3021 - St Albans
Recruitment postcode(s) [2] 38745 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 299185 0
Charities/Societies/Foundations
Name [1] 299185 0
Society of Critical Care Medicine
Country [1] 299185 0
United States of America
Funding source category [2] 299191 0
Hospital
Name [2] 299191 0
Western Health Office for Research 2016 Research Grant
Country [2] 299191 0
Australia
Primary sponsor type
Individual
Name
Dr 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] 298454 0
None
Name [1] 298454 0
Address [1] 298454 0
Country [1] 298454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300109 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 300109 0
Ethics committee country [1] 300109 0
Australia
Date submitted for ethics approval [1] 300109 0
22/11/2017
Approval date [1] 300109 0
30/01/2018
Ethics approval number [1] 300109 0
HREC/17/MH/432

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2585 2585 0 0
/AnzctrAttachments/374885-2017.371 Protocol Version 2 clean.docx (Protocol)
Attachments [2] 2586 2586 0 0
/AnzctrAttachments/374885-2017.371 Ethics Approval.pdf (Ethics approval)
Attachments [3] 2587 2587 0 0
/AnzctrAttachments/374885-HREC17MH432 2017 371 App I - PICF V2 Clean.docx (Participant information/consent)

Contacts
Principal investigator
Name 82598 0
Dr Kimberley Haines
Address 82598 0
Physiotherapy Department
Sunshine Hospital
176 Furlong Rd
St Albans
Victoria 3021
Country 82598 0
Australia
Phone 82598 0
+61383456661
Fax 82598 0
Email 82598 0
[email protected]
Contact person for public queries
Name 82599 0
Kimberley Haines
Address 82599 0
Physiotherapy Department
Sunshine Hospital
176 Furlong Rd
St Albans
Victoria 3021
Country 82599 0
Australia
Phone 82599 0
+61383456661
Fax 82599 0
Email 82599 0
[email protected]
Contact person for scientific queries
Name 82600 0
Kimberley Haines
Address 82600 0
Physiotherapy Department
Sunshine Hospital
176 Furlong Rd
St Albans
Victoria 3021
Country 82600 0
Australia
Phone 82600 0
+61383456661
Fax 82600 0
Email 82600 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.