PMID- 33482395

OWN - NLM
STAT- In-Data-Review
LR - 20210402
IS - 1559-2030 (Electronic)
IS - 1551-7144 (Print)
IS - 1551-7144 (Linking)
VI - 102
DP - 2021 Mar
TI - Family automated voice reorientation (FAVoR) intervention for mechanically
ventilated patients in the intensive care unit: Study protocol for a
randomized
controlled trial.
PG - 106277
LID - S1551-7144(21)00013-6 [pii]
LID - 10.1016/j.cct.2021.106277 [doi]
AB - 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.
CI - Copyright © 2021 Elsevier Inc. All rights reserved.
FAU - Munro, Cindy L
AU - Munro CL
AD - University of Miami School of Nursing and Health Studies, 5030 Brunson Drive,
Coral
Gables, FL, United States. Electronic address: cmunro@miami.edu.
FAU - Liang, Zhan
AU - Liang Z
AD - University of Miami School of Nursing and Health Studies, 5030 Brunson Drive,
Coral
Gables, FL, United States.
FAU - Ji, Ming
AU - Ji M
AD - University of South Florida College of Nursing, 12901 Bruce B. Downs Blvd,
Tampa,
FL, United States.
FAU - Elías, Maya N
AU - Elías MN
AD - University of Miami School of Nursing and Health Studies, 5030 Brunson Drive,
Coral
Gables, FL, United States.
FAU - Chen, Xusheng
AU - Chen X
AD - University of Miami School of Nursing and Health Studies, 5030 Brunson Drive,
Coral
Gables, FL, United States.
FAU - Calero, Karel
AU - Calero K
AD - Department of Pulmonary, Critical Care, and Sleep Medicine, University of
South
Florida College of Medicine, 12901 Bruce B. Downs Blvd, Tampa, FL, United
States.
FAU - Ely, E Wesley
AU - Ely EW
AD - 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 21st Ave S, Nashville,
TN,
United States; Veteran's Affairs TN Valley, Geriatrics Research, Education
and
Clinical Center (GRECC), 1310 24th Ave S, Nashville, TN, United States.
LA - eng
GR - R01 NR016702/NR/NINR NIH HHS/United States
PT - Journal Article
DEP - 20210119
TA - Contemp Clin Trials
JT - Contemporary clinical trials
JID - 101242342
SB - IM
PMC - PMC8009830
MID - NIHMS1670075
OTO - NOTNLM
OT - Cognition
OT - Critical illness
OT - Delirium
OT - Mechanical ventilation
OT - Randomized controlled trial
OT - Sleep
COIS- Conflict of Interest Disclosure: Please see attachments.
EDAT- 2021/01/23 06:00
MHDA- 2021/01/23 06:00
PMCR- 2022/03/01
CRDT- 2021/01/22 20:10
PHST- 2020/11/09 00:00 [received]
PHST- 2021/01/03 00:00 [revised]
PHST- 2021/01/04 00:00 [accepted]
PHST- 2022/03/01 00:00 [pmc-release]
PHST- 2021/01/23 06:00 [pubmed]
PHST- 2021/01/23 06:00 [medline]
PHST- 2021/01/22 20:10 [entrez]
AID - S1551-7144(21)00013-6 [pii]
AID - 10.1016/j.cct.2021.106277 [doi]
PST - ppublish
SO - Contemp Clin Trials. 2021 Mar;102:106277. doi: 10.1016/j.cct.2021.106277.
Epub 2021
Jan 19.