Modified Hospital Elder Life Program at Intensive Care Unit

ConditionICU Delirium
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

266 Participants
are divided into 2 treatment groups
Group A: mHELP@ICUExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of ICU delirium

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

Time frame
Admitted to ICU for 14 days
2

ICU delirium days

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

Time frame
Admitted to ICU for 14 days
3

Incidence of ICU coma

Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.

Time frame
Admitted to ICU for 14 days
4

ICU coma days

Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.

Time frame
Admitted to ICU for 14 days

Secondary outcomes

1

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.

Time frame
At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.
2

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.

Time frame
At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.
3

30-second sit-to-stand test

Participants will be asked for sit-to-stand repeatedly for 30 seconds.

Time frame
Post-ICU 48 hours; day 30 and day 90 since ICU admission.
4

Barthel index for activities of daily living (ADL)

Measured by ADL in score, range from 0-100 score, higher score indicated health condition

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

Other outcomes

Sponsors and contacts

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