Modified Hospital Elder Life Program at Intensive Care Unit

ICU Delirium Clinical Trial

— mHelp@ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054828
• Other study ID #: 202301153RINB
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: Chen Chia-Hui, PhD
• Phone: +886-2-23123456
• Email: cherylchen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 )

Related Conditions & MeSH terms

• Delirium
• ICU Delirium

Intervention

Behavioral:
• mHELP@ICU
The 14-day mHELP@ICU consists of the following three components: Cognitive engagement twice daily: Participants will receive orienting communication, plus one of the following training on attention, memory, or function execution. Physical activity once daily: Participants will receive a passive range of motion(ROM) and/or anti-gravity ROM exercise if tolerated. Feeding monitor daily: The exact feeding data will be abstracted from medical records.

Locations

Country	Name	City	State
Taiwan	Cheryl, Chia-Hui Chen, PhD	Taipei	National Taiwan University

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (31)

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Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703. — View Citation

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ICU delirium	Delirium (yes/no) using ICDSC will be abstracted from medical records.	Admitted to ICU for 14 days
Primary	ICU delirium days	Delirium (yes/no) using ICDSC will be abstracted from medical records.	Admitted to ICU for 14 days
Primary	Incidence of ICU coma	Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.	Admitted to ICU for 14 days
Primary	ICU coma days	Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.	Admitted to ICU for 14 days
Primary	Days of delirium- and coma-free days (DCFDs)	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.	Admitted to ICU for 14 days
Primary	Mortality	Data will be obtained from medical records or participants' families.	Admitted to ICU for 90 days
Primary	Length of hospital stay	Data will be obtained from medical records.	At hospital discharge
Secondary	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.	At baseline, 14, 30, and 90 days since ICU admission.
Secondary	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.	At baseline, 14, 30, and 90 days since ICU admission.
Secondary	30-second sit-to-stand test	Participants will be asked for sit-to-stand repeatedly for 30 seconds.	At 14, 30, and 90 days since ICU admission.
Secondary	Barthel index for activities of daily living (ADL)	Measured by ADL in score, range from 0-100 score, higher score indicated health condition	At baseline, 14, 30, and 90 days since ICU admission.
Secondary	Montreal Cognitive Assessment (MoCA)	Participants' cognitive function will be evaluated using th MoCA. Score range from 0-30 score, higher than 23.5 scores indicates normal cognitive.	At 14, 30, and 90 days since ICU admission.
Secondary	Color Trails Test (CTT)	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.	At 14, 30, and 90 days since ICU admission.
Secondary	Accuracy rate of ICDSC data (yes/no)	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.	Randomly select four days per week to verify the accuracy of ICDSC data during the first three months of the study.