Modified Hospital Elder Life Program at Intensive Care Unit
- Conditions
- ICU Delirium
- Interventions
- Behavioral: mHELP@ICU
- Registration Number
- NCT06054828
- Lead Sponsor
- National Taiwan University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 266
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mHELP@ICU mHELP@ICU Participants will receive cognitive engagement twice daily, have physical activity once daily, and be monitored for their feeding. The intervention will be administered for 14 days or until hospital discharge or death.
- Primary Outcome Measures
Name Time Method ICU coma days Admitted to ICU for 14 days Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.
Days of delirium- and coma-free days (DCFDs) Admitted to ICU for 14 days DCFDs (yes/no) are defined as the number of days during the study period during which the patient was alive without delirium or coma associated with any cause and obtained.
Mortality Admitted to ICU for 90 days Data will be obtained from medical records or participants' families.
Length of hospital stay At hospital discharge Data will be obtained from medical records.
Incidence of ICU coma Admitted to ICU for 14 days Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.
Incidence of ICU delirium Admitted to ICU for 14 days Delirium (yes/no) using ICDSC will be abstracted from medical records.
ICU delirium days Admitted to ICU for 14 days Delirium (yes/no) using ICDSC will be abstracted from medical records.
- Secondary Outcome Measures
Name Time Method Medical Research Council (MRC) score At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission. 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) At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission. 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 Post-ICU 48 hours; day 30 and day 90 since ICU admission. Participants will be asked for sit-to-stand repeatedly for 30 seconds.
Barthel index for activities of daily living (ADL) At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission. Measured by ADL in score, range from 0-100 score, higher score indicated health condition
Montreal Cognitive Assessment (MoCA) Post-ICU 48 hours; day 30 and day 90 since ICU admission. Participants' cognitive function will be evaluated using th MoCA. Score range from 0-30 score, higher than 23.5 scores indicates normal cognitive.
Color Trails Test (CTT) Post-ICU 48 hours; day 30 and day 90 since ICU admission. Participants' visual attention and effortful executive processing abilities will be evaluated using the CTT; the time taken to complete each part of the CTT is recorded in seconds and is compared to normative data.
Accuracy rate of ICDSC data (yes/no) Randomly select four days per week to verify the accuracy of ICDSC data during the first three months of the study. 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.
Trial Locations
- Locations (1)
Cheryl, Chia-Hui Chen, PhD
🇨🇳Taipei, National Taiwan University, Taiwan