Modified Hospital Elder Life Program at Intensive Care Unit

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Incidence of ICU delirium [Time frame: Admitted to ICU for 14 days]
• ICU delirium days [Time frame: Admitted to ICU for 14 days]
• Incidence of ICU coma [Time frame: Admitted to ICU for 14 days]
• ICU coma days [Time frame: Admitted to ICU for 14 days]
• Days of delirium- and coma-free days (DCFDs) [Time frame: Admitted to ICU for 14 days]
• Mortality [Time frame: Admitted to ICU for 90 days]
• Length of hospital stay [Time frame: At hospital discharge]

Secondary outcome measures (7)

• Medical Research Council (MRC) score [Time frame: 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) [Time frame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.]
• 30-second sit-to-stand test [Time frame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.]
• Barthel index for activities of daily living (ADL) [Time frame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.]
• Montreal Cognitive Assessment (MoCA) [Time frame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.]
• Color Trails Test (CTT) [Time frame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.]
• 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.]

Eligibility 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 )

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Cheryl, Chia-Hui Chen, PhD — Taipei

Publications

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753. PMID 15082703
• Yamamoto T, Mizobata Y, Kawazoe Y, Miyamoto K, Ohta Y, Morimoto T, Yamamura H. Incidence, risk factors, and outcomes for sepsis-associated delirium in patients with mechanical ventilation: A sub-analysis of a multicenter randomized controlled trial. J Crit Care. 2020 Apr;56:140-144. doi: 10.1016/j.jcrc.2019.12.018. Epub 2019 Dec 24. PMID 31901649
• Fiest KM, Soo A, Hee Lee C, Niven DJ, Ely EW, Doig CJ, Stelfox HT. Long-Term Outcomes in ICU Patients with Delirium: A Population-based Cohort Study. Am J Respir Crit Care Med. 2021 Aug 15;204(4):412-420. doi: 10.1164/rccm.202002-0320OC. PMID 33823122
• Lat I, McMillian W, Taylor S, Janzen JM, Papadopoulos S, Korth L, Ehtisham A, Nold J, Agarwal S, Azocar R, Burke P. The impact of delirium on clinical outcomes in mechanically ventilated surgical and trauma patients. Crit Care Med. 2009 Jun;37(6):1898-905. doi: 10.1097/CCM.0b013e31819ffe38. PMID 19384221
• Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372. PMID 24088092
• Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. Intensive Care Med. 2014 Mar;40(3):370-9. doi: 10.1007/s00 PMID 24257969
• Balas MC, Pun BT, Pasero C, Engel HJ, Perme C, Esbrook CL, Kelly T, Hargett KD, Posa PJ, Barr J, Devlin JW, Morse A, Barnes-Daly MA, Puntillo KA, Aldrich JM, Schweickert WD, Harmon L, Byrum DG, Carson SS, Ely EW, Stollings JL. Common Challenges to Effective ABCDEF Bundle Implementation: The ICU Liberation Campaign Experience. Crit Care Nurse. 2019 Feb;39(1):46-60. doi: 10.4037/ccn2019927. PMID 30710036
• Kotfis K, Marra A, Ely EW. ICU delirium - a diagnostic and therapeutic challenge in the intensive care unit. Anaesthesiol Intensive Ther. 2018;50(2):160-167. doi: 10.5603/AIT.a2018.0011. Epub 2018 Jun 8. PMID 29882581

Identifiers

NCT: NCT06054828 · 202301153RINB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗