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Family automated voice reorientation (FAVoR) intervention for mechanically ventilated patients in the intensive care unit: Study protocol for a randomized controlled trial.
Munro, Cindy L; Liang, Zhan; Ji, Ming; Elías, Maya N; Chen, Xusheng; Calero, Karel; Ely, E Wesley.
  • Munro CL; University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States. Electronic address: cmunro@miami.edu.
  • Liang Z; University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States.
  • Ji M; University of South Florida College of Nursing, 12901 Bruce B. Downs Blvd, Tampa, FL, United States.
  • Elías MN; University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States.
  • Chen X; University of Miami School of Nursing and Health Studies, 5030 Brunson Drive, Coral Gables, FL, United States.
  • Calero K; Department of Pulmonary, Critical Care, and Sleep Medicine, University of South Florida College of Medicine, 12901 Bruce B. Downs Blvd, Tampa, FL, United States.
  • Ely EW; Center for Critical Illness, Brain Dysfunction, and Survivorship (CIBS), Vanderbilt University Medical Center, 2525 West End Avenue Suite 450, Nashville, TN, United States; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, 1161 2
Contemp Clin Trials ; 102: 106277, 2021 03.
Article in English | MEDLINE | ID: covidwho-1034177
ABSTRACT
Delirium in the intensive care unit (ICU) affects up to 80% of critically ill, mechanically ventilated (MV) adults. Delirium is associated with substantial negative outcomes, including increased hospital complications and long-term effects on cognition and health status in ICU survivors. The purpose of this randomized controlled trial is to test the effectiveness of a Family Automated Voice Reorientation (FAVoR) intervention on delirium among critically ill MV patients. The FAVoR intervention uses scripted audio messages, which are recorded by the patient's family and played at hourly intervals during daytime hours. This ongoing orientation to the ICU environment through recorded messages in a voice familiar to the patient may enable the patient to more accurately interpret the environment and thus reduce risk of delirium. The study's primary aim is to test the effect of the FAVoR intervention on delirium in critically ill MV adults in the ICU. The secondary aims are to explore (1) if the effect of FAVoR on delirium is mediated by sleep, (2) if selected biobehavioral factors moderate the effects of FAVoR on delirium, and (3) the effects of FAVoR on short-term and long-term outcomes, including cognition and health status. Subjects (n = 178) are randomly assigned to the intervention or control group within 48 h of initial ICU admission and intubation. The intervention group receives FAVoR over a 5-day period, while the control group receives usual care. Delirium-free days, sleep and activity, cognition, patient-reported health status and sleep quality, and data regarding iatrogenic/environmental and biobehavioral factors are collected.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiration, Artificial / Delirium Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adult / Humans Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiration, Artificial / Delirium Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adult / Humans Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article