title: Improving delirium care in the intensive care unit: the design of a pragmatic study.
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
  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.
  
  
  CONCLUSIONS
  The proposed study will evaluate the content and the delivery process of a multicomponent pharmacological management program for delirium in the ICU.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00842608.
authors.affiliation: Department of Pharmacy Practice, Purdue University School of Pharmacy, West Lafayette, IN, USA. ncampbell@regenstrief.org
authors.forename: Noll L
authors.initials: NL
authors.lastname: Campbell
authors.forename: Babar A
authors.initials: BA
authors.lastname: Khan
authors.forename: Mark
authors.initials: M
authors.lastname: Farber
authors.forename: Tiffany
authors.initials: T
authors.lastname: Campbell
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Perkins
authors.forename: Siu L
authors.initials: SL
authors.lastname: Hui
authors.forename: Greg
authors.initials: G
authors.lastname: Abernathy
authors.forename: John
authors.initials: J
authors.lastname: Buckley
authors.forename: Regg
authors.initials: R
authors.lastname: Sing
authors.forename: Jason
authors.initials: J
authors.lastname: Tricker
authors.forename: Mohammad
authors.initials: M
authors.lastname: Zawahiri
authors.forename: Malaz A
authors.initials: MA
authors.lastname: Boustani
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001185:Artificial Intelligence; D001569:Benzodiazepines / Q000627:therapeutic use; D018680:Cholinergic Antagonists / Q000627:therapeutic use; D003422:Critical Care / Q000592:standards*; D020000:Decision Support Systems, Clinical; D003693:Delirium / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D004359:Drug Therapy, Combination; D005260:Female; D006220:Haloperidol / Q000627:therapeutic use; D017052:Hospital Mortality; D006801:Humans; D007196:Indiana; D007362:Intensive Care Units / Q000592:standards*; D007902:Length of Stay; D008297:Male; D050316:Medical Order Entry Systems; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011619:Psychotropic Drugs / Q000627:therapeutic use*; D058996:Quality Improvement / Q000592:standards*; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018680:Cholinergic Antagonists; D011619:Psychotropic Drugs; D001569:Benzodiazepines; D006220:Haloperidol