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
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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 |
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ICU Delirium | Behavioral: mHELP@ICU | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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Behavioral: mHELP@ICU
The 14-day mHELP@ICU consists of the following three components:
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No Intervention: Control group
Participants in the control group will receive the usual care.
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- Incidence of ICU delirium [ Time Frame: Admitted to ICU for 14 days ]Delirium (yes/no) using ICDSC will be abstracted from medical records.
- ICU delirium days [ Time Frame: Admitted to ICU for 14 days ]Delirium (yes/no) using ICDSC will be abstracted from medical records.
- 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.
- 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.
- 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.
- Mortality [ Time Frame: Admitted to ICU for 90 days ]Data will be obtained from medical records or participants' families.
- Length of hospital stay [ Time Frame: At hospital discharge ]Data will be obtained from medical records.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 )
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
Contact: Chen Chia-Hui, PhD | +886-2-23123456 ext 288438 | cherylchen@ntu.edu.tw |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Delirium Intensive care units Intervention Mortality |
Mobility Cognitive function Stepped-wedge cluster randomized controlled trial |
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |