Modified Hospital Elder Life Program at Intensive Care Unit: A Stepped-Wedge Cluster Randomized Controlled Trial

What this Trial Is About

Delirium is a sudden brain dysfunction affecting up to 81% of patients on mechanical ventilation in the intensive care unit (ICU). It is linked to worse physical and cognitive outcomes, longer hospital stays, and higher risk of death. This research aims to develop a nursing-driven program called the modified Hospital Elder Life Program at the ICU (mHELP@ICU) to lower delirium rates, increase days without delirium or coma, and improve patients' function, cognition, and survival up to three months after ICU admission. The study is conducted in two phases over three years. The first phase checks the accuracy of delirium assessments by ICU nurses using a standard checklist and provides education if needed. The second phase is a clinical trial enrolling about 266 adults on mechanical ventilation for more than 48 hours. Participants are randomly assigned to receive either the mHELP@ICU intervention, which involves twice-daily cognitive engagement, daily physical activity exercises, and feeding monitoring for up to 14 days, or usual care as a control. During the study, researchers will collect daily data on delirium and coma for up to 14 days or until ICU discharge or death. They will also assess survival, cognitive function, physical ability, and daily living activities at 48 hours, 14 days, 30 days, and 90 days after ICU admission. Outcomes such as length of hospital stay and accuracy of delirium assessments will be tracked. The study involves monitoring by trained staff and blinded evaluators to measure the effects of the nursing intervention on ICU patient outcomes.

Modified Hospital Elder Life Program at Intensive Care Unit