{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:37:14Z","timestamp":1787017034590,"version":"build-2736575974"},"reference-count":65,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2025,1,2]],"date-time":"2025-01-02T00:00:00Z","timestamp":1735776000000},"content-version":"unspecified","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013216","name":"School of Graduate Studies, Queen's University","doi-asserted-by":"publisher","award":["Queen's Public Scholars Fellowship"],"award-info":[{"award-number":["Queen's Public Scholars Fellowship"]}],"id":[{"id":"10.13039\/501100013216","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,12,5]]},"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a single-centre feasibility study. Survivors of critical illness will be eligible if: age \u226518 years, life expectancy \u22656 months and high risk for PICS. We define high risk as ICU stay \u22654\u2009days 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 &gt;80%, (2) enrolment rate of 4 participants\/month, (3) follow-up rate&gt;70% and (4) data capture rate &gt;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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Implications<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study has received approval (6039808) from the Queen\u2019s 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06681649\">NCT06681649<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-086799","type":"journal-article","created":{"date-parts":[[2025,1,3]],"date-time":"2025-01-03T01:35:17Z","timestamp":1735868117000},"page":"e086799","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and 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