search
Back to results

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

Primary Purpose

ICU Delirium

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
mHELP@ICU
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ICU Delirium focused on measuring Delirium, Intensive care units, Intervention, Mortality, Mobility, Cognitive function, Stepped-wedge cluster randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 )

Sites / Locations

  • Cheryl, Chia-Hui Chen, PhDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mHELP@ICU

Control group

Arm Description

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.

Participants in the control group will receive the usual care.

Outcomes

Primary Outcome Measures

Incidence of ICU delirium
Delirium (yes/no) using ICDSC will be abstracted from medical records.
ICU delirium days
Delirium (yes/no) using ICDSC will be abstracted from medical records.
Incidence of ICU coma
Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.
ICU coma 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)
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
Data will be obtained from medical records or participants' families.
Length of hospital stay
Data will be obtained from medical records.

Secondary Outcome Measures

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.
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.
30-second sit-to-stand test
Participants will be asked for sit-to-stand repeatedly for 30 seconds.
Barthel index for activities of daily living (ADL)
Measured by ADL in score, range from 0-100 score, higher score indicated health condition
Montreal Cognitive Assessment (MoCA)
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)
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)
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.

Full Information

First Posted
August 8, 2023
Last Updated
September 19, 2023
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06054828
Brief Title
Modified Hospital Elder Life Program at Intensive Care Unit
Acronym
mHelp@ICU
Official Title
Modified Hospital Elder Life Program at Intensive Care Unit: A Stepped-Wedge Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU Delirium
Keywords
Delirium, Intensive care units, Intervention, Mortality, Mobility, Cognitive function, Stepped-wedge cluster randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mHELP@ICU
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive the usual care.
Intervention Type
Behavioral
Intervention Name(s)
mHELP@ICU
Intervention Description
The 14-day mHELP@ICU consists of the following three components: Cognitive engagement twice daily: Participants will receive orienting communication, plus one of the following training on attention, memory, or function execution. Physical activity once daily: Participants will receive a passive range of motion(ROM) and/or anti-gravity ROM exercise if tolerated. Feeding monitor daily: The exact feeding data will be abstracted from medical records.
Primary Outcome Measure Information:
Title
Incidence of ICU delirium
Description
Delirium (yes/no) using ICDSC will be abstracted from medical records.
Time Frame
Admitted to ICU for 14 days
Title
ICU delirium days
Description
Delirium (yes/no) using ICDSC will be abstracted from medical records.
Time Frame
Admitted to ICU for 14 days
Title
Incidence of ICU coma
Description
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
Title
ICU coma days
Description
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
Title
Days of delirium- and coma-free days (DCFDs)
Description
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.
Time Frame
Admitted to ICU for 14 days
Title
Mortality
Description
Data will be obtained from medical records or participants' families.
Time Frame
Admitted to ICU for 90 days
Title
Length of hospital stay
Description
Data will be obtained from medical records.
Time Frame
At hospital discharge
Secondary Outcome Measure Information:
Title
Medical Research Council (MRC) score
Description
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, 14, 30, and 90 days since ICU admission.
Title
Functional Status Score for the Intensive Care Unit (FSS-ICU)
Description
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, 14, 30, and 90 days since ICU admission.
Title
30-second sit-to-stand test
Description
Participants will be asked for sit-to-stand repeatedly for 30 seconds.
Time Frame
At 14, 30, and 90 days since ICU admission.
Title
Barthel index for activities of daily living (ADL)
Description
Measured by ADL in score, range from 0-100 score, higher score indicated health condition
Time Frame
At baseline, 14, 30, and 90 days since ICU admission.
Title
Montreal Cognitive Assessment (MoCA)
Description
Participants' cognitive function will be evaluated using th MoCA. Score range from 0-30 score, higher than 23.5 scores indicates normal cognitive.
Time Frame
At 14, 30, and 90 days since ICU admission.
Title
Color Trails Test (CTT)
Description
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.
Time Frame
At 14, 30, and 90 days since ICU admission.
Title
Accuracy rate of ICDSC data (yes/no)
Description
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.
Time Frame
Randomly select four days per week to verify the accuracy of ICDSC data during the first three months of the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Chia-Hui, PhD
Phone
+886-2-23123456
Ext
288438
Email
cherylchen@ntu.edu.tw
Facility Information:
Facility Name
Cheryl, Chia-Hui Chen, PhD
City
Taipei
State/Province
National Taiwan University
ZIP/Postal Code
10055
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Chia-Hui, PhD
Phone
+886-2-23123456
Ext
288438
Email
cherylchen@ntu.edu.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
15082703
Citation
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.
Results Reference
background
PubMed Identifier
31901649
Citation
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.
Results Reference
background
PubMed Identifier
33823122
Citation
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.
Results Reference
background
PubMed Identifier
19384221
Citation
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.
Results Reference
background
PubMed Identifier
24088092
Citation
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.
Results Reference
background
PubMed Identifier
24257969
Citation
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/s00134-013-3136-0. Epub 2013 Nov 21.
Results Reference
background
PubMed Identifier
30710036
Citation
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.
Results Reference
background
PubMed Identifier
29882581
Citation
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.
Results Reference
background
PubMed Identifier
29278283
Citation
Maldonado JR. Delirium pathophysiology: An updated hypothesis of the etiology of acute brain failure. Int J Geriatr Psychiatry. 2018 Nov;33(11):1428-1457. doi: 10.1002/gps.4823. Epub 2017 Dec 26.
Results Reference
background
PubMed Identifier
10053175
Citation
Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.
Results Reference
background
PubMed Identifier
30076080
Citation
Hshieh TT, Yang T, Gartaganis SL, Yue J, Inouye SK. Hospital Elder Life Program: Systematic Review and Meta-analysis of Effectiveness. Am J Geriatr Psychiatry. 2018 Oct;26(10):1015-1033. doi: 10.1016/j.jagp.2018.06.007. Epub 2018 Jun 26.
Results Reference
background
Citation
American Geriatrics Society. AGS COCARE® . 2022
Results Reference
background
PubMed Identifier
28098628
Citation
Ely EW. The ABCDEF Bundle: Science and Philosophy of How ICU Liberation Serves Patients and Families. Crit Care Med. 2017 Feb;45(2):321-330. doi: 10.1097/CCM.0000000000002175.
Results Reference
background
PubMed Identifier
25888230
Citation
Trogrlic Z, van der Jagt M, Bakker J, Balas MC, Ely EW, van der Voort PH, Ista E. A systematic review of implementation strategies for assessment, prevention, and management of ICU delirium and their effect on clinical outcomes. Crit Care. 2015 Apr 9;19(1):157. doi: 10.1186/s13054-015-0886-9.
Results Reference
background
PubMed Identifier
33332818
Citation
Zhang S, Han Y, Xiao Q, Li H, Wu Y. Effectiveness of Bundle Interventions on ICU Delirium: A Meta-Analysis. Crit Care Med. 2021 Feb 1;49(2):335-346. doi: 10.1097/CCM.0000000000004773.
Results Reference
background
PubMed Identifier
28538964
Citation
Chen CC, Li HC, Liang JT, Lai IR, Purnomo JDT, Yang YT, Lin BR, Huang J, Yang CY, Tien YW, Chen CN, Lin MT, Huang GH, Inouye SK. Effect of a Modified Hospital Elder Life Program on Delirium and Length of Hospital Stay in Patients Undergoing Abdominal Surgery: A Cluster Randomized Clinical Trial. JAMA Surg. 2017 Sep 1;152(9):827-834. doi: 10.1001/jamasurg.2017.1083.
Results Reference
background
PubMed Identifier
36205994
Citation
Li HC, Yeh TY, Wei YC, Ku SC, Xu YJ, Chen CC, Inouye S, Boehm LM. Association of Incident Delirium With Short-term Mortality in Adults With Critical Illness Receiving Mechanical Ventilation. JAMA Netw Open. 2022 Oct 3;5(10):e2235339. doi: 10.1001/jamanetworkopen.2022.35339.
Results Reference
background
PubMed Identifier
25662947
Citation
Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.
Results Reference
background
PubMed Identifier
32087011
Citation
Hemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. Int J Epidemiol. 2020 Jun 1;49(3):979-995. doi: 10.1093/ije/dyz237.
Results Reference
background
PubMed Identifier
11730446
Citation
Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
Results Reference
background
PubMed Identifier
16137350
Citation
Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. doi: 10.1186/cc3729. Epub 2005 Jun 1.
Results Reference
background
PubMed Identifier
32228666
Citation
Cowan SL, Preller J, Goudie RJB. Evaluation of the E-PRE-DELIRIC prediction model for ICU delirium: a retrospective validation in a UK general ICU. Crit Care. 2020 Mar 30;24(1):123. doi: 10.1186/s13054-020-2838-2. No abstract available.
Results Reference
background
PubMed Identifier
35272910
Citation
Li HC, Chen CC, Yeh TY, Liao SC, Hsu AS, Wei YC, Shun SC, Ku SC, Inouye SK. Predicting hospital mortality and length of stay: A prospective cohort study comparing the Intensive Care Delirium Screening Checklist versus Confusion Assessment Method for the Intensive Care Unit. Aust Crit Care. 2023 May;36(3):378-384. doi: 10.1016/j.aucc.2022.01.010. Epub 2022 Mar 7.
Results Reference
background
PubMed Identifier
30113379
Citation
Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
Results Reference
background
PubMed Identifier
25251759
Citation
Zaal IJ, Devlin JW, Peelen LM, Slooter AJ. A systematic review of risk factors for delirium in the ICU. Crit Care Med. 2015 Jan;43(1):40-7. doi: 10.1097/CCM.0000000000000625.
Results Reference
background
PubMed Identifier
31723916
Citation
Park SY, Lee HB. Prevention and management of delirium in critically ill adult patients in the intensive care unit: a review based on the 2018 PADIS guidelines. Acute Crit Care. 2019 May;34(2):117-125. doi: 10.4266/acc.2019.00451. Epub 2019 Apr 17.
Results Reference
background
PubMed Identifier
26404065
Citation
Abdulla H, Smith K, Atherton PJ, Idris I. Role of insulin in the regulation of human skeletal muscle protein synthesis and breakdown: a systematic review and meta-analysis. Diabetologia. 2016 Jan;59(1):44-55. doi: 10.1007/s00125-015-3751-0. Epub 2015 Sep 24.
Results Reference
background
PubMed Identifier
11176150
Citation
De Jonghe B, Appere-De-Vechi C, Fournier M, Tran B, Merrer J, Melchior JC, Outin H. A prospective survey of nutritional support practices in intensive care unit patients: what is prescribed? What is delivered? Crit Care Med. 2001 Jan;29(1):8-12. doi: 10.1097/00003246-200101000-00002.
Results Reference
background
PubMed Identifier
28794882
Citation
Uozumi M, Sanui M, Komuro T, Iizuka Y, Kamio T, Koyama H, Mouri H, Masuyama T, Ono K, Lefor AK. Interruption of enteral nutrition in the intensive care unit: a single-center survey. J Intensive Care. 2017 Aug 4;5:52. doi: 10.1186/s40560-017-0245-9. eCollection 2017.
Results Reference
background
PubMed Identifier
18495054
Citation
Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.
Results Reference
background
PubMed Identifier
34401939
Citation
Stollings JL, Kotfis K, Chanques G, Pun BT, Pandharipande PP, Ely EW. Delirium in critical illness: clinical manifestations, outcomes, and management. Intensive Care Med. 2021 Oct;47(10):1089-1103. doi: 10.1007/s00134-021-06503-1. Epub 2021 Aug 16.
Results Reference
background

Learn more about this trial

Modified Hospital Elder Life Program at Intensive Care Unit

We'll reach out to this number within 24 hrs