Clinical trial NCT06054828: Modified Hospital Elder Life Program at Intensive Care Unit
Official title: Modified Hospital Elder Life Program at Intensive Care Unit: A Stepped-Wedge Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ICU Delirium
Keywords: Delirium
Intensive care units
Intervention
Mortality
Mobility
Cognitive function
Stepped-wedge cluster randomized controlled trial
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria of the second phase

* 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.

Exclusion Criteria of the second phase

* participants who are placed on droplet or contact precautions (e.g., Open TB, SARS, COVID-19 )

Primary outcomes:
measure: Incidence of ICU delirium
timeFrame: Admitted to ICU for 14 days
measure: ICU delirium days
timeFrame: Admitted to ICU for 14 days
measure: Incidence of ICU coma
timeFrame: Admitted to ICU for 14 days
measure: ICU coma days
timeFrame: Admitted to ICU for 14 days
measure: Days of delirium- and coma-free days (DCFDs)
timeFrame: Admitted to ICU for 14 days
measure: Mortality
timeFrame: Admitted to ICU for 90 days
measure: Length of hospital stay
timeFrame: At hospital discharge
Secondary outcomes:
measure: Medical Research Council (MRC) score
timeFrame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.
measure: Functional Status Score for the Intensive Care Unit (FSS-ICU)
timeFrame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.
measure: 30-second sit-to-stand test
timeFrame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.
measure: Barthel index for activities of daily living (ADL)
timeFrame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.
measure: Color Trails Test (CTT)
timeFrame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.
measure: Accuracy rate of ICDSC data (yes/no)
timeFrame: Randomly select four days per week to verify the accuracy of ICDSC data during the first three months of the study.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheryl, Chia-Hui Chen, PhD
state: National Taiwan University
Study officials:
References:
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