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Trials
Published in: Trials 1/2011

Open Access 01-12-2011 | Study protocol

Improving delirium care in the intensive care unit: The design of a pragmatic study

Authors: Noll L Campbell, Babar A Khan, Mark Farber, Tiffany Campbell, Anthony J Perkins, Siu L Hui, Greg Abernathy, John Buckley, Regg Sing, Jason Tricker, Mohammad Zawahiri, Malaz A Boustani

Published in: Trials | Issue 1/2011

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Abstract

Background

Delirium prevalence in the intensive care unit (ICU) is high. Numerous psychotropic agents are used to manage delirium in the ICU with limited data regarding their efficacy or harms.

Methods/Design

This is a randomized controlled trial of 428 patients aged 18 and older suffering from delirium and admitted to the ICU of Wishard Memorial Hospital in Indianapolis. Subjects assigned to the intervention group will receive a multicomponent pharmacological management protocol for delirium (PMD) and those assigned to the control group will receive no change in their usual ICU care. The primary outcomes of the trial are (1) delirium severity as measured by the Delirium Rating Scale revised-98 (DRS-R-98) and (2) delirium duration as determined by the Confusion Assessment Method for the ICU (CAM-ICU). The PMD protocol targets the three neurotransmitter systems thought to be compromised in delirious patients: dopamine, acetylcholine, and gamma-aminobutyric acid. The PMD protocol will target the reduction of anticholinergic medications and benzodiazepines, and introduce a low-dose of haloperidol at 0.5-1 mg for 7 days. The protocol will be delivered by a combination of computer (artificial intelligence) and pharmacist (human intelligence) decision support system to increase adherence to the PMD protocol.

Discussion

The proposed study will evaluate the content and the delivery process of a multicomponent pharmacological management program for delirium in the ICU.

Trial Registration

ClinicalTrials.gov: NCT00842608
Appendix
Available only for authorised users
Literature
1.
Cooper LM, Lindle-Zwirble TW: Medicare Intensive Care Unit Use: Analysis of incidence, cost, and payment. Crit Care Med. 2004, 32: 2247-2253.CrossRefPubMed
2.
National Hospital Discharge Survey: Public use data file documentation. U.S. Department of Health and Human Services. Centers for Disease Control and Prevention. 2005, National Center for Health Statistics. Division of Health Care Statistics. Hospital Care Statistics Branch, (accessed May 8, 2007), http://​www.​cdc.​gov/​nchs/​about/​major/​hdasd/​nhds.​htm
3.
DeFrances CJ, Podgornik MN: 2004 National Hospital Discharge Survey. Advance data from vital and health statistics. National Center for Health Statistics. 2006, Hyattsville, MD, no 371
4.
Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians: Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002, 30 (1): 119-141. 10.1097/00003246-200201000-00020.CrossRefPubMed
5.
Jackson JC, Gordon SM, Hopkins RO: The association between delirium and cognitive decline: A review of the empirical literature. Neuropsychol Rev. 2004, 14: 87-98.CrossRefPubMed
6.
Saravay SM, Kaplowitz M, Kurek J: How do delirium and dementia increase length of stay of elderly general medical inpatients?. Psychosomatics. 2004, 45: 235-42. 10.1176/appi.psy.45.3.235.CrossRefPubMed
7.
Chelluri L, Pinsky MR, Donahoe MP: Long-term outcome of critically ill older patients requiring intensive care. JAMA. 1993, 269: 3119-3123. 10.1001/jama.269.24.3119.CrossRefPubMed
8.
Witlox J, Eurelings JS, de Jonghe JF: Delirium in elderly patients and the risk of post-discharge mortality, institutionalization and dementia: a meta-analysis. JAMA. 2010, 304 (4): 443-451. 10.1001/jama.2010.1013.CrossRefPubMed
9.
Pandharipande PP, Pun BT, Herr DL: Effect of sedation with dexmedetomidine vs. lorazepam on acute brain dysfunction in mechanically ventilated patients: the MENDS randomized controlled trial. JAMA. 2007, 298 (22): 2644-2653. 10.1001/jama.298.22.2644.CrossRefPubMed
10.
Gunther ML, Morandi A, and Ely EW: Pathophysiology of delirium in the intensive care unit. Crit Care Clin. 2008, 24: 45-65. 10.1016/j.ccc.2007.10.002.CrossRefPubMed
11.
Inouye SK, Ferrucci L: Elucidating the pathophysiology of delirium and the interrelationship of delirium and dementia. Journals of Gerontology Series A-Biological Sciences & Medical Sciences. 2006, 61 (12): 1277-80.CrossRef
12.
Marcantonio ER, Rudolph JL, Culley D, Crosby G, Alsop D, Inouye SK: Serum biomarkers for delirium. Journals of Gerontology Series A-Biological Sciences & Medical Sciences. 2006, 61 (12): 1281-6.CrossRef
13.
Gunther ML, Jackson JC, Ely EW: The cognitive consequences of critical illness: practical recommendations for screening and assessment. Critical Care Clinics. 2007, 23 (3): 491-506. 10.1016/j.ccc.2007.07.001.CrossRefPubMed
14.
Hopkins RO, Jackson JC: Long-term neurocognitive function after critical illness. Chest. 2006, 130 (3): 869-78. 10.1378/chest.130.3.869.CrossRefPubMed
15.
Boustani M, Campbell N, Munger S, Maidment I, Fox C: Impact of anticholinergics on the aging brain: a review and practical application. Aging Health. 2008, 4: 311-320. 10.2217/1745509X.4.3.311.CrossRef
16.
Campbell NL, Ayub A, Fox GC, Munger SL, Ott C, Guzman O, Farber M, Ademuyiwa A, Singh R: Pharmacological Management of Delirium in Hospitalized Adults-A Systematic Evidence Review. J Gen Intern Med. 2009, 24 (7): 848-853. 10.1007/s11606-009-0996-7.CrossRefPubMedPubMedCentral
17.
Boustani M, Buttar A: Delirium in hospitalized older adults. Primary Care Geriatrics, A Case-Based Approach. Edited by: R Ham, P Sloane, G Warshaw. 2007, 15: 210-218. 5CrossRef
18.
Weber JB, Coverdale JH, Kunik ME: Delirium: current trends in prevention and treatment. Intern Med J. 2004, 34 (3): 115-121. 10.1111/j.1444-0903.2004.00549.x.CrossRefPubMed
19.
Breitbart W, Marotta R, Platt MM: A double-blind trial of haloperidol, chlorpromazine, and lorazepam in the treatment of delirium in hospitalized AIDS patients. Am J Psychiatry. 1996, 153 (2): 231-237.CrossRefPubMed
20.
Ely EW, Stephens RK, Jackson JC, Thomason JW, Truman B, Gordon S, Dittus RS, Bernard GR: Current opinions regarding the importance, diagnosis, and management of delirium in the intensive care unit: a survey of 912 healthcare professionals. Crit Care Med. 2004, 21 (1): 106-112.CrossRef
21.
Inouye SK: Delirium in older persons. N Engl J Med. 2006, 354 (11): 1157-1165. 10.1056/NEJMra052321.CrossRefPubMed
22.
Trzepacz PT: Is there a final common neural pathway in delirium? Focus on acetylcholine and dopamine. Semin Clin Neuropsychiatry. 2000, 5 (2): 132-148.PubMed
23.
Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH: Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003, 163: 2716-2724. 10.1001/archinte.163.22.2716.CrossRefPubMed
24.
Maccioli GA, Dorman T, Brown BR, mazuski JE, McLean BA, Kuszaj JM, Rosenbaum SH, Frankel LR, Devlin JW, Govert JA, Smith B, Peruzzi WT: Clinical practice guidelines for the maintenance of patient physical safety in the intensive care unit: use of restraining therapies-American College of Critical Care Medicine Task Force2001-2002. Crit Care Med. 2003, 31 (11): 2665-2676. 10.1097/01.CCM.0000095463.72353.AD.CrossRefPubMed
25.
American Psychiatric Association: Practice guidelines for the treatment of patients with delirium. American Psychiatric Association. Am J Psychiatry. 1999, 156 (5 Suppl): 1-20.
26.
Chow TW, MacLean CH: Quality indicators for dementia in vulnerable community-dwelling and hospitalized elders. Ann Intern Med. 2001, 135: 668-676.CrossRefPubMed
27.
Boustani M, Baker MS, Campbell N, Munger S, Hui S, Castellucio P, Farber M, Guzman O, Ademuyiwa A, Miller D, Callahan C: Impact and recognition of cognitive impairment among hospitalized elders. J Hosp Med. 2010, 5 (2): 69-75. 10.1002/jhm.589.CrossRefPubMedPubMedCentral
28.
Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK: The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002, 166 (10): 1338-44. 10.1164/rccm.2107138. Nov 15CrossRefPubMed
29.
Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R: Evaluation of delirium in critically ill patients: validation of the confusion assessment method for the intensive care unit (CAM-ICU). Crit Care Med. 2001, 29: 1370-1379. 10.1097/00003246-200107000-00012.CrossRefPubMed
30.
Boustani MA, Munger S, Beck R, Campbell N, Weiner M: A gero-informatics tool to enhance the care of hospitalized older adults with cognitive impairment. Clin Interv Aging. 2007, 2 (2): 247-253.PubMedPubMedCentral
31.
32.
Ash JS, Sittig DF, Campbell EM, Guappone KP, Dykstra RH: Some unintended consequences of clinical decision support systems. AMIA Annu Symp Proc. 2007, 26-30.
33.
Dexter PR, Perkins S, Overhage JM, Maharry K, Kohler RB, McDonald CJ: A computerized reminder system to increase the use of preventive care for hospitalized patients. N Engl J Med. 2001, 345: 965-70. 10.1056/NEJMsa010181.CrossRefPubMed
34.
Meyer-Massetti C, Cheng CM, Sharpe BA, Meier CR, Guglielmo BJ: The FDA extended warning of intravenous haloperidol and Torsades de Pointes: how should institutions respond?. J Hosp Med. 2010, 5: E8-E16.CrossRefPubMed
35.
Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR: Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003, 289 (22): 2983-91. 10.1001/jama.289.22.2983.CrossRefPubMed
36.
Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L: Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001, 286: 2703-2710. 10.1001/jama.286.21.2703.CrossRefPubMed
37.
Cole MG, McCusker J, Bellavance F: Systematic detection and multidisciplinary care of delirium in older medical inpatients: a randomized trial. CMAJ. 2002, 167: 753-9.PubMedPubMedCentral
38.
Cole MG, McCusker J, Dendukuri N, Han L: Symptoms of delirium among elderly medical inpatients with or without dementia. J Neuropsychiatry Clin Neurosci. 2002, 14: 167-75. 10.1176/appi.neuropsych.14.2.167.CrossRefPubMed
39.
Trzepacz PT, Baker RW, Greenhouse J: A symptom rating scale for delirium. Psychiatry Res. 1988, 23: 89-97. 10.1016/0165-1781(88)90037-6.CrossRefPubMed
40.
Trzepacz PT, Mittal D, Torres R: Validation of the Delirium Rating Scale-revised-98. J Neuropsychiatry Clin Neurosci. 2001, 13 (2): 229-242. 10.1176/appi.neuropsych.13.2.229.CrossRefPubMed
41.
Jorm AF: The Informant Questionnaire on cognitive decline in the elderly (IQCODE): a review. Int Psychogeriatr. 2004, 16 (3): 275-93. 10.1017/S1041610204000390.CrossRefPubMed
42.
Knaus WA, Zimmerman JE, Wagner DP: APACHE-Acute physiology and chronic health evaluation: A physiologically based classification system. Crit Care Med. 1981, 9: 591-597. 10.1097/00003246-198108000-00008.CrossRefPubMed
43.
Charlson ME, Pompei P, Ales KL: A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987, 40: 373-383. 10.1016/0021-9681(87)90171-8.CrossRefPubMed
44.
Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK: The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001, 27: 1892-1900. 10.1007/s00134-001-1132-2.CrossRefPubMed
45.
Pandharipande P, Shintani A, Peterson J, Pun BT, Wilkinson GR, Dittus RS, Bernard GR, Ely EW: Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006, 104 (1): 21-6. 10.1097/00000542-200601000-00005.CrossRefPubMed
46.
Simpson GM, Angus JW: A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl. 1970, 212: 11-9.CrossRefPubMed
47.
Barnes TR: A rating scale for drug-induced akathisia. Br J Psychiatry. 1989, 154: 672-676. 10.1192/bjp.154.5.672.CrossRefPubMed
Metadata
Title
Improving delirium care in the intensive care unit: The design of a pragmatic study
Authors
Noll L Campbell
Babar A Khan
Mark Farber
Tiffany Campbell
Anthony J Perkins
Siu L Hui
Greg Abernathy
John Buckley
Regg Sing
Jason Tricker
Mohammad Zawahiri
Malaz A Boustani
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-139

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