Modified Hospital Elder Life Program at Intensive Care Unit

NCT06054828 | Recruiting

• 1 other identifier: 202301153RINB
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

ICU Delirium

Keywords

Delirium; Intensive care units; Intervention; Mortality; Mobility; Cognitive function; Stepped-wedge cluster randomized controlled trial

Outcome Measures

Primary Outcomes (7)

• Incidence of ICU delirium

  Delirium (yes/no) using ICDSC will be abstracted from medical records.

  Admitted to ICU for 14 days

• ICU delirium days

  Delirium (yes/no) using ICDSC will be abstracted from medical records.

  Admitted to ICU for 14 days

• 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

• 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

• 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

• Mortality

  Data will be obtained from medical records or participants' families.

  Admitted to ICU for 90 days

• Length of hospital stay

  Data will be obtained from medical records.

  At hospital discharge

Secondary Outcomes (7)

• Medical Research Council (MRC) score

  At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.

• 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.

• 30-second sit-to-stand test

  Post-ICU 48 hours; day 30 and day 90 since ICU admission.

• Barthel index for activities of daily living (ADL)

  At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.

• Montreal Cognitive Assessment (MoCA)

  Post-ICU 48 hours; day 30 and day 90 since ICU admission.

Study Arms (2)

mHELP@ICU

EXPERIMENTAL

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.

Behavioral: mHELP@ICU

Control group

NO INTERVENTION

Participants in the control group will receive the usual care.

Interventions

mHELP@ICU BEHAVIORAL

The 14-day mHELP@ICU consists of the following three components: 1. Cognitive engagement twice daily: Participants will receive orienting communication, plus one of the following training on attention, memory, or function execution. 2. Physical activity once daily: Participants will receive a passive range of motion(ROM) and/or anti-gravity ROM exercise if tolerated. 3. Feeding monitor daily: The exact feeding data will be abstracted from medical records.

mHELP@ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Cheryl, Chia-Hui Chen, PhD

Taipei, National Taiwan University, 10055, Taiwan

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Chen Chia-Hui, PhD

CONTACT

+886-2-23123456; cherylchen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 26, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-10

Locations

TW (1)