Improving care for ICU patients to reduce delirium
Modified Hospital Elder Life Program at Intensive Care Unit: A Stepped-Wedge Cluster Randomized Controlled Trial
This study is testing a new program in ICUs to see if it can help reduce delirium in patients on mechanical ventilation by improving their mental engagement, physical activity, and nutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei, National Taiwan University) |
| Trial ID | NCT06054828 on ClinicalTrials.gov |
What this trial studies
This study aims to implement a modified Hospital Elder Life Program (mHELP@ICU) in intensive care units to address ICU delirium, which affects a significant number of patients on mechanical ventilation. The intervention focuses on enhancing cognitive engagement, physical activity, and nutritional support for critically ill patients. The study will assess the effectiveness of this nursing-driven intervention in reducing the incidence of delirium and improving patient outcomes, including cognitive function and mortality rates, three months after ICU admission. The research is divided into two phases, with the first phase ensuring accurate delirium assessments by ICU nurses using the Intensive Care Delirium Screening Checklist.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving mechanical ventilation and are expected to be intubated for more than 48 hours without pre-existing delirium or coma.
Not a fit: Patients placed on droplet or contact precautions, such as those with open TB, SARS, or COVID-19, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of delirium in ICU patients, leading to better cognitive and functional outcomes.
How similar studies have performed: Other studies have shown success with similar interventions aimed at reducing ICU delirium, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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 )
Where this trial is running
Taipei, National Taiwan University
- Cheryl, Chia-Hui Chen, PhD — Taipei, National Taiwan University, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chen Chia-Hui, PhD
- Email: cherylchen@ntu.edu.tw
- Phone: +886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.