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Modified Hospital Elder Life Program at Intensive Care Unit (mHelp@ICU)

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ClinicalTrials.gov Identifier: NCT06054828
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
ICU Delirium Behavioral: mHELP@ICU Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modified Hospital Elder Life Program at Intensive Care Unit: A Stepped-Wedge Cluster Randomized Controlled Trial
Actual Study Start Date : September 5, 2023
Estimated Primary Completion Date : July 31, 2026
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: mHELP@ICU

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.
No Intervention: Control group
Participants in the control group will receive the usual care.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of ICU delirium [ Time Frame: Admitted to ICU for 14 days ]
    Delirium (yes/no) using ICDSC will be abstracted from medical records.

  2. ICU delirium days [ Time Frame: Admitted to ICU for 14 days ]
    Delirium (yes/no) using ICDSC will be abstracted from medical records.

  3. Incidence of ICU coma [ Time Frame: Admitted to ICU for 14 days ]
    Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.

  4. ICU coma days [ Time Frame: Admitted to ICU for 14 days ]
    Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.

  5. Days of delirium- and coma-free days (DCFDs) [ Time Frame: 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.

  6. Mortality [ Time Frame: Admitted to ICU for 90 days ]
    Data will be obtained from medical records or participants' families.

  7. Length of hospital stay [ Time Frame: At hospital discharge ]
    Data will be obtained from medical records.


Secondary Outcome Measures :
  1. Medical Research Council (MRC) score [ Time Frame: At baseline, 14, 30, and 90 days 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.

  2. Functional Status Score for the Intensive Care Unit (FSS-ICU) [ Time Frame: At baseline, 14, 30, and 90 days 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.

  3. 30-second sit-to-stand test [ Time Frame: At 14, 30, and 90 days since ICU admission. ]
    Participants will be asked for sit-to-stand repeatedly for 30 seconds.

  4. Barthel index for activities of daily living (ADL) [ Time Frame: At baseline, 14, 30, and 90 days since ICU admission. ]
    Measured by ADL in score, range from 0-100 score, higher score indicated health condition

  5. Montreal Cognitive Assessment (MoCA) [ Time Frame: At 14, 30, and 90 days 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.

  6. Color Trails Test (CTT) [ Time Frame: At 14, 30, and 90 days 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.

  7. Accuracy rate of ICDSC data (yes/no) [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 )
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054828


Contacts
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Contact: Chen Chia-Hui, PhD +886-2-23123456 ext 288438 cherylchen@ntu.edu.tw

Locations
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Taiwan
Cheryl, Chia-Hui Chen, PhD Recruiting
Taipei, National Taiwan University, Taiwan, 10055
Contact: Chen Chia-Hui, PhD    +886-2-23123456 ext 288438    cherylchen@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
More Information
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Publications:
American Geriatrics Society. AGS COCARE® . 2022

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT06054828    
Other Study ID Numbers: 202301153RINB
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Delirium
Intensive care units
Intervention
Mortality
 Mobility
Cognitive function
Stepped-wedge cluster randomized controlled trial
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders