About this trial
Delirium, a form of acute brain dysfunction, occurs in up to 81% of patients receiving mechanical ventilation in the intensive care unit (ICU). Delirium occurring in the ICU is associated with increased functional dependency, cognitive impairment, longer length of hospital stay, and mortality. This study aim to develop a nursing-driven ICU delirium intervention to reduce incidence of delirium, increase the delirium-and coma-free days (DCFDs), and improve ICU patients' function, cognition, and mortality outcomes 3 months following their ICU admission. The "modified Hospital Elder life Program at the ICU (mHELP@ICU)" will be provided to ensure critically ill patients are cognitively engaged, physically active, and nutritionally well-fed.
This three-year study is divided into two phases. The first phase aims to ensure the accuracy of delirium assessment using the Intensive Care Delirium Screening Checklist (ICDSC) by ICU nurses of three participating ICUs. The ICDSC records assessed by ICU nurses will be abstracted from medical records and compared with a gold standard ICDSC evaluation by a well-trained, independent assessor. Cohen's kappa will be reported to represent the consistency of the ICDSC assessment between delirium data from medical records and the independent assessor. When the Cohen's kappa is less than 0.8, a 3-month bedside teaching and real-time feedback education program will be implemented at three ICU units to improve the accuracy of ICDSC assessment by ICU nurses. The second phase will be a clinical trial using a stepped-wedge cluster randomized controlled trial design. Adult (18 years and older) critically ill patients receiving mechanical ventilation will be consecutively enrolled from three mix-medical ICUs at a studied medical center. Estimated 266 participants will be cluster-randomized into the intervention and control groups. Participants in the intervention group will receive a 14-day mHELP@ICU, provided by a trained mHELP nurse, while the participants who received the usual care will serve as controls. Effects of mHELP@ICU will be evaluated using the daily delirium and coma data (max 14 days, or until death or ICU discharge) retrieved from the medical records, along with the participants' mortality, cognitive, and functional outcomes, which a blinded outcome assessor will assess at 48 hours, 14 days, 30 days, and 90 days after ICU admission.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
participants who are 18 years old or older.
participants who receive oral endotracheal intubation with mechanical ventilation and are expected intubation greater than 48 hours.
participants are free from delirium or coma before ICU admission.
Disqualifiers
participants who are placed on droplet or contact precautions (e.g., Open TB, SARS, COVID-19 )
Trial design
Parallel
Treatments tested in this trial
mHELP@ICU
BehavioralThe 14-day mHELP@ICU consists of the following three components: 1. Cognitive engagement twice daily: Participants will receive orienting communication, plus one of the following training on attention, memory, or function execution. 2. Physical activity once daily: Participants will receive a passive range of motion(ROM) and/or anti-gravity ROM exercise if tolerated. 3. Feeding monitor daily: The exact feeding data will be abstracted from medical records.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of ICU delirium
Delirium (yes/no) using ICDSC will be abstracted from medical records.
ICU delirium days
Delirium (yes/no) using ICDSC will be abstracted from medical records.
Incidence of ICU coma
Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.
ICU coma days
Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.
Secondary outcomes
Medical Research Council (MRC) score
Participants' muscle strength will be evaluated using the medical research council scale (MRC). Score range from 0 to 60; a higher score indicates better muscle strength.
Functional Status Score for the Intensive Care Unit (FSS-ICU)
Participants' functional status will be evaluated using the FSS-ICU. Score range from 0 to 35, a higher score indicates better functional status.
30-second sit-to-stand test
Participants will be asked for sit-to-stand repeatedly for 30 seconds.
Barthel index for activities of daily living (ADL)
Measured by ADL in score, range from 0-100 score, higher score indicated health condition
Sponsors and contacts
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