Family automated voice reorientation (FAVoR) intervention for mechanically ventilated patients in the intensive care unit: Study protocol for a randomized controlled trial
- PMID: 33482395
- PMCID: PMC8009830
- DOI: 10.1016/j.cct.2021.106277
Family automated voice reorientation (FAVoR) intervention for mechanically ventilated patients in the intensive care unit: Study protocol for a randomized controlled trial
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.
Keywords: Cognition; Critical illness; Delirium; Mechanical ventilation; Randomized controlled trial; Sleep.
Copyright © 2021 Elsevier Inc. All rights reserved.
Conflict of interest statement
Figures
Similar articles
-
Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial.Trials. 2022 Jul 19;23(1):576. doi: 10.1186/s13063-022-06448-w. Trials. 2022. PMID: 35854358 Free PMC article. Clinical Trial.
-
Adjunct low-dose ketamine infusion vs standard of care in mechanically ventilated critically ill patients at a Tertiary Saudi Hospital (ATTAINMENT Trial): study protocol for a randomized, prospective, pilot, feasibility trial.Trials. 2020 Mar 20;21(1):288. doi: 10.1186/s13063-020-4216-4. Trials. 2020. PMID: 32197636 Free PMC article.
-
Delirium prevention in critically ill adults through an automated reorientation intervention - A pilot randomized controlled trial.Heart Lung. 2017 Jul-Aug;46(4):234-238. doi: 10.1016/j.hrtlng.2017.05.002. Epub 2017 Jun 9. Heart Lung. 2017. PMID: 28606450 Clinical Trial.
-
Non-pharmacological interventions for sleep promotion in the intensive care unit.Cochrane Database Syst Rev. 2015 Oct 6;2015(10):CD008808. doi: 10.1002/14651858.CD008808.pub2. Cochrane Database Syst Rev. 2015. PMID: 26439374 Free PMC article. Review.
-
Benzodiazepine versus nonbenzodiazepine-based sedation for mechanically ventilated, critically ill adults: a systematic review and meta-analysis of randomized trials.Crit Care Med. 2013 Sep;41(9 Suppl 1):S30-8. doi: 10.1097/CCM.0b013e3182a16898. Crit Care Med. 2013. PMID: 23989093 Review.
References
-
- Zhang Z, Pan L, Ni H: Impact of delirium on clinical outcome in critically ill patients: a meta-analysis. General hospital psychiatry 2013, 35(2):105–111. - PubMed
-
- 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, 291(14):1753–1762. - PubMed
-
- Shehabi Y, Riker RR, Bokesch PM, Wisemandle W, Shintani A, Ely EW: Delirium duration and mortality in lightly sedated, mechanically ventilated intensive care patients. Critical care medicine 2010, 38(12):2311–2318. - PubMed
-
- Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM et al.: Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Critical care medicine 2013, 41(1):263–306. - PubMed
Publication types
MeSH terms
Grants and funding
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical