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Testing a Peer Support Program for Intensive Care Unit Survivors to improve Psychological Recovery - Pilot Randomized Controlled Trial

icuRESOLVE (Intensive Care Unit REcovery Solutions cO-Led through surVivor Engagement): Co-designing Peer Support With ICU Survivors - Phase 2 Pilot Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000615280
Acronym
icuRESOLVE Phase 2
Enrollment
80
Registered
2018-04-20
Start date
2018-04-25
Completion date
2020-12-17
Last updated
2022-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

International and local research indicates that ICU survivors (patients and families) experience adverse outcomes. In Australia, ICU survivors return home with little or no follow-up. Peer support holds potential to improve post-ICU outcomes although this warrants explorations. Typically new models of care are designed only from the perspective of the health professionals without any patient or family input. We have recently conducted Phase 1 of the icuRESOLVE Project, where we engaged both ICU survivors and staff using a new and innovative method called experience-based co-design (EBCD). Through EBCD a Peer Support model for ICU survivors was developed. This study (phase 2 of the icuRESOLVE Project) aims to test the developed Peer Support Model to see if it is feasible to deliver (attendance rates, participant satisfaction, participant recruitment) as well as the impact of attending peer support on psychological and social outcomes. This is a small pilot study and the results of this study will inform a larger, multi-site randomized study. The time commitment required by participants in the intervention group (peer support) is estimated at 13 hours over approximately 14 weeks. For participants in the control group (no peer support), time commitment is estimated at 1 hour (to complete health related questionnaires). Anticipated ethical issues for the intervention group relate to a small risk of psychological distress by participating in the group sessions as they will be discussing their ICU experiences and recovery. For participants in both groups their may be a small degree that some of the questionnaires may be stressful or upsetting. Survivors are able to access any help needed. We do not anticipate any risk to staff.

Interventions

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 increasingl

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

Sponsors

Dr Kimberley Haines
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026