IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers
Introduction Survivors of critical illness and their caregivers are at risk for long-term cognitive, physical and psychiatric impairments known as post-intensive care syndrome (PICS) and PICS-family, respectively. This study will assess the feasibility of a randomised controlled trial (RCT) evaluati...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/1/e086799.full |
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| author | Sunita Mathur John Muscedere David M Maslove Miranda Hunt John Gordon Boyd Stephanie Sibley Tracy Boyd Michelle Tryon Natasha Arianne Jawa Michaela Hanley Robin Westphal Afolasade Fakolade |
| author_facet | Sunita Mathur John Muscedere David M Maslove Miranda Hunt John Gordon Boyd Stephanie Sibley Tracy Boyd Michelle Tryon Natasha Arianne Jawa Michaela Hanley Robin Westphal Afolasade Fakolade |
| author_sort | Sunita Mathur |
| collection | DOAJ |
| description | Introduction Survivors of critical illness and their caregivers are at risk for long-term cognitive, physical and psychiatric impairments known as post-intensive care syndrome (PICS) and PICS-family, respectively. This study will assess the feasibility of a randomised controlled trial (RCT) evaluating an intensive care unit (ICU) follow-up care bundle versus standard-of-care for ICU patients and their caregivers.Methods and analysis This is a single-centre feasibility study. Survivors of critical illness will be eligible if: age ≥18 years, life expectancy ≥6 months and high risk for PICS. We define high risk as ICU stay ≥4 days or involving 1+ of mechanical ventilation, tracheostomy, delirium or lack of access to a primary care physician (PCP). 20 ICU survivor-primary caregiver dyads will be enrolled (n=10 dyads per group) and randomised 1:1 to the intervention versus control group. The intervention will be: (1) diaries to journal patient experiences, (2) information packages on expectations post-discharge and (3) specialised follow-up care at 1 and 3 months post-discharge. The control group will receive standard of care in the ICU and follow-up with their PCP. The primary outcome is feasibility, defined as: (1) consent rate >80%, (2) enrolment rate of 4 participants/month, (3) follow-up rate>70% and (4) data capture rate >80%. Our secondary objective is to explore the perspectives of survivors of critical illness and their families about the intervention and their participation in the study. Tertiary outcomes will be a battery of cognitive, physical functioning and psychiatric outcomes.Implications Survivorship from critical illness extends beyond surviving an ICU stay. This project will lay the foundation for performing a large, multicentre pragmatic RCT with survivors of critical illness and their caregivers, paving the way for improved long-term healthcare.Ethics and dissemination This study has received approval (6039808) from the Queen’s University Health Sciences/Affiliated Teaching Hospitals Research Ethics Board. Results will be presented at critical care conferences. A lay summary co-designed with ICU survivor participants will be provided to patients.Trial registration number NCT06681649. |
| format | Article |
| id | doaj-art-79c76da6a3ab4be69808d31ee586f088 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-79c76da6a3ab4be69808d31ee586f0882025-08-20T01:47:25ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-086799IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregiversSunita Mathur0John Muscedere1David M Maslove2Miranda Hunt3John Gordon Boyd4Stephanie Sibley5Tracy Boyd6Michelle Tryon7Natasha Arianne Jawa8Michaela Hanley9Robin Westphal10Afolasade Fakolade116 School of Rehabilitation Therapy, Queen`s University, Kingston, Ontario, Canada3 Medicine, Queen`s University, Kingston, Ontario, Canada3 Medicine, Queen`s University, Kingston, Ontario, Canada4 Critical Care Medicine, Queen`s University, Kingston, Ontario, Canada1 Centre for Neuroscience Studies, Queen`s University, Kingston, Ontario, Canada4 Critical Care Medicine, Queen`s University, Kingston, Ontario, Canada4 Critical Care Medicine, Queen`s University, Kingston, Ontario, Canada4 Critical Care Medicine, Queen`s University, Kingston, Ontario, Canada1 Centre for Neuroscience Studies, Queen`s University, Kingston, Ontario, Canada4 Critical Care Medicine, Queen`s University, Kingston, Ontario, Canada4 Critical Care Medicine, Queen`s University, Kingston, Ontario, Canada6 School of Rehabilitation Therapy, Queen`s University, Kingston, Ontario, CanadaIntroduction Survivors of critical illness and their caregivers are at risk for long-term cognitive, physical and psychiatric impairments known as post-intensive care syndrome (PICS) and PICS-family, respectively. This study will assess the feasibility of a randomised controlled trial (RCT) evaluating an intensive care unit (ICU) follow-up care bundle versus standard-of-care for ICU patients and their caregivers.Methods and analysis This is a single-centre feasibility study. Survivors of critical illness will be eligible if: age ≥18 years, life expectancy ≥6 months and high risk for PICS. We define high risk as ICU stay ≥4 days or involving 1+ of mechanical ventilation, tracheostomy, delirium or lack of access to a primary care physician (PCP). 20 ICU survivor-primary caregiver dyads will be enrolled (n=10 dyads per group) and randomised 1:1 to the intervention versus control group. The intervention will be: (1) diaries to journal patient experiences, (2) information packages on expectations post-discharge and (3) specialised follow-up care at 1 and 3 months post-discharge. The control group will receive standard of care in the ICU and follow-up with their PCP. The primary outcome is feasibility, defined as: (1) consent rate >80%, (2) enrolment rate of 4 participants/month, (3) follow-up rate>70% and (4) data capture rate >80%. Our secondary objective is to explore the perspectives of survivors of critical illness and their families about the intervention and their participation in the study. Tertiary outcomes will be a battery of cognitive, physical functioning and psychiatric outcomes.Implications Survivorship from critical illness extends beyond surviving an ICU stay. This project will lay the foundation for performing a large, multicentre pragmatic RCT with survivors of critical illness and their caregivers, paving the way for improved long-term healthcare.Ethics and dissemination This study has received approval (6039808) from the Queen’s University Health Sciences/Affiliated Teaching Hospitals Research Ethics Board. Results will be presented at critical care conferences. A lay summary co-designed with ICU survivor participants will be provided to patients.Trial registration number NCT06681649.https://bmjopen.bmj.com/content/15/1/e086799.full |
| spellingShingle | Sunita Mathur John Muscedere David M Maslove Miranda Hunt John Gordon Boyd Stephanie Sibley Tracy Boyd Michelle Tryon Natasha Arianne Jawa Michaela Hanley Robin Westphal Afolasade Fakolade IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers BMJ Open |
| title | IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers |
| title_full | IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers |
| title_fullStr | IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers |
| title_full_unstemmed | IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers |
| title_short | IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers |
| title_sort | impact icu feasibility study pragmatic mixed methods randomised controlled trial of a follow up care intervention for survivors of critical illness and caregivers |
| url | https://bmjopen.bmj.com/content/15/1/e086799.full |
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