IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.015 | 0.020 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.007 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.003 | 0.003 |
| Research integrity | 0.006 | 0.004 |
| Insufficient payload (model declined to judge) | 0.020 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".