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Article history: Objectives: Explore the effect of an automated reorientation intervention on ICU delirium in a prospective
Received 26 October 2016 randomized controlled trial.
Received in revised form Background: Delirium is common in ICU patients, and negatively affects outcomes. Few prevention
4 May 2017
strategies have been tested.
Accepted 5 May 2017
Available online xxx
Methods: Thirty ICU patients were randomized to 3 groups. Ten received hourly recorded messages in a
family member’s voice during waking hours over 3 ICU days, 10 received the same messages in a non-
family voice, and 10 (control) did not receive any automated reorientation messages. The primary
Keywords:
Delirium
outcome was delirium free days during the intervention period (evaluated by CAM-ICU). Groups were
Intensive care unit compared by Fisher’s Exact Test.
Family Results: The family voice group had more delirium free days than the non-family voice group, and
Delirium prevention significantly more delirium free days (p ¼ 0.0437) than the control group.
Nursing care Conclusions: Reorientation through automated, scripted messages reduced incidence of delirium. Using
Critical illness identical scripted messages, family voice was more effective than non-family voice.
Delirium intervention Ó 2017 Elsevier Inc. All rights reserved.
0147-9563/$ e see front matter Ó 2017 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.hrtlng.2017.05.002
2 C.L. Munro et al. / Heart & Lung xxx (2017) 1e5
Received all episodes of intervention (n = 5) Received all episodes of intervention (n = 3) Received all episodes of usual care (n = 6)
Did not receive full intervention: Did not receive full intervention: Did not receive full usual care:
Early icu discharge (n = 4) Early icu discharge (n = 6) Early icu discharge (n = 3)
Off the unit for testing (n = 1) Off the unit for testing (n = 0) Off the unit for testing (n = 0)
Transferred to palliative care (n = 0) Transferred to palliative care (n = 1) Transferred to palliative care (n = 0)
Death (n = 0) Death (n = 0) Death (n = 1)
Analyzed (n = 10)
environment to the patient. We thought that messages delivered in Automated reorientation intervention
a voice familiar to the patient might result in greater attention to
the messages and be comforting. This study tested the hypothesis Intervention development
that providing ongoing orientation to the ICU environment through A draft script of reorientation messages was developed based on
recorded audio messages would reduce risk of delirium in critically published research by our team and others about patients’ recall of
ill adults; both familiar voices (family voice) and an unfamiliar ICU experiences.17e19 The script was refined based on reviews of 3
voice (unknown voice) were tested against no recorded voice critical care experts, and further adjustments to message volume,
(control). length, and speaker location were made following input from
healthy nurse volunteers in the ICU setting. The original script was
Methods developed in English; a Spanish version was translated from En-
glish by a certified medical translator and back-translated.
A three group, prospective, randomized controlled trial (RCT)
design was used to examine the effects of the automated reor- Message description
ientation intervention on delirium. Ten subjects were randomized Each message was scripted, was no longer than 2 min long,
to receive automated reorientation messages in a family member’s included the subject’s name (preferred name as recommended by
voice (family voice group), ten subjects received the same messages the subject’s family), and used simple terms at a 5th grade
in an unfamiliar voice (unknown voice group) and ten subjects reading level. Other than the subject’s name, the recorded mes-
(control group) did not receive any automated reorientation mes- sage was not specific to any patient condition, procedure, or
sages. The study CONSORT diagram is presented as Fig. 1. family situation. Each message was delivered only during daytime
hours (to provide general time orientation), stated that the
Human subjects protection message was recorded, and reoriented the subject frequently
throughout the day to help them understand they were in the
The study was approved by the hospital where data were ICU. Additional message elements followed in random order, and
collected and by the Institutional Review Board of the university. provided information about the critical care environment, the
Signed consent was obtained from subjects or their legally autho- visual and auditory stimuli to be expected, and the availability of
rized representatives. Twelve subjects provided consent for providers and family. Random ordering of elements within the
themselves, and consent was obtained from legally authorized recorded message at each delivery was designed to reduce mes-
representatives for the 18 subjects who were unable to consent for sage repetition. The elements of the reorientation message are
themselves. presented in Table 1.
The script for messages was recorded by a family member of the
family’s choice (for the family voice group) or by a bilingual female
Sample
research staff person (for the unknown voice group). Selection of
the English or Spanish script was based on the family’s decision
Subjects were eligible if they were over 18 years old and within
regarding which language would be most meaningful to the sub-
24 h of ICU admission. Exclusion criteria included anticipation by
ject. The messages were digitally recorded through a sound card
the clinical provider of imminent patient death, medical contrain-
and stored as a standard Microsoft wave file.
dication to the intervention (for example, psychiatric auditory
hallucinations, or profound deafness), or inability to speak either
Intervention delivery
English or Spanish. Subjects were recruited in 5 ICUs in a large
At predetermined time intervals over 3 days in the ICU (every
urban level I trauma center in the Southeastern United States. A
hour for 8 h during the daytime hours, beginning at 9:00 am and
total of 30 subjects were randomized into 3 groups by the bio-
ending at 4:00 p.m.), a recorded message was played back in the
stastician co-investigator (MJ) prior to the first enrollment using a
patient’s room through the room’s television audio system. The
computerized random number generator.
C.L. Munro et al. / Heart & Lung xxx (2017) 1e5 3
Table 1
Family voice reorientation message.
The personalized introduction is delivered at the beginning of each message. The order of numbered sentences in the script below are randomly changed for each hourly
message. Sentence #8 may be omitted if/when it becomes not applicable due to extubation.
Personalized Introduction:
Hello _______________________________, (insert name of patient) This is ________________________, your _______________________ , (insert your name and relationship to
the patient). This is a recorded message to help you understand what is going on around you.
1) Do not be scared.
2) It is OK.
3) You are a patient at Tampa General Hospital.
4) Your nurses and doctors are here looking after you.
5) It is loud and noisy because of the machines helping you get better.
6) You have some wires and tubes in place to help you recover.
7) You may have something on your wrists to keep you from pulling at the wires and tubes by accident.
8) You can’t talk right now because of your breathing tube, but the nurses know you might be uncomfortable and are giving you medicine for that.
9) Please try to be calm and patient as the nurses and doctors work to get you feeling better.
10) All of our family know you’re here and we are in and out, looking after you too.
timeframe chosen for intervention delivery coincided with usual delirium in ICU patients.2 A systematic review of 16 research
waking hours, so as not to disturb sleep or interrupt family visits in studies involving 1523 participants using five screening tools
the evening hours. Intervention began at the earliest available concluded that the CAM-ICU was the most specific bedside tool for
daytime hour following completion of family or staff recording. the assessment of delirium in critically ill patients, with pooled
Subjects received a maximum of 24 recorded messages (8 messages sensitivity of 75.5% and specificity of 95.8%.21
per day for 3 days). Instances where the message was not delivered, When CAM-ICU criteria for delirium were not met (negative
for example when the subject was off the unit for procedures, were result) for either of the assessments for a study day, and no clinical
noted. The intervention ended if the subject was discharged from providers had documented intervening delirium, the day was
the ICU during the study period. The number of messages delivered counted as a delirium free day. Mean days of delirium, where at
was summed for each subject, and group means were calculated. least one assessment indicated that CAM-ICU criteria were met
(positive result) on the study day, were also calculated for each
Delirium group.
The primary outcome for the study was delirium free days. Sample characteristics
Delirium was evaluated twice daily (prior to initiation of and
following completion of the intervention administration) using the In order to assess group equivalence and identify potential
Confusion Assessment Method (CAM)emodified ICU version.20 For covariates, demographic data were collected, including sex,
this research study, CAM-ICU determinations were made by the ethnicity, race, and age. In addition, baseline data about severity of
research nurse (PC) who is an experienced critical care RN trained illness and comorbidities were collected using the APACHE III
in CAM-ICU administration. The CAM-ICU was developed for use by scoring system, calculated on the most deranged values during the
clinical providers who are not psychiatrists. Four features are first 24 h of ICU admission.
evaluated as present or absent using standardized methods: 1)
acute onset or fluctuating course, 2) inattention, 3) altered level of Analysis
consciousness, and 4) disorganized thinking. A patient is assessed
to have delirium only if features 1 and 2 are both present with All enrolled subjects were analyzed. Descriptive statistics were
either feature 3 or 4 also present. The CAM-ICU is recognized in the produced to describe the 3 groups and to compare their charac-
Society for Critical Care Medicine’s Clinical Practice Guidelines for teristics (see Table 2). Groups were equivalent by ANOVA (including
the Management of Pain, Agitation, and Delirium in adult patients positive CAM-ICU at study admission and days in ICU) and no ad-
in the ICU settings as a valid, reliable, and feasible tool to detect justments of covariates were needed. A Fisher’s Exact Test at
Table 2
Sample characteristics.
Limitations 5. Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of
delirium are associated with 1-year mortality in an older intensive care unit
population. Am J Respir Crit Care Med. 2009;180(11):1092e1097.
The sample size of this study was small. The small sample size 6. Shehabi Y, Riker RR, Bokesch PM, Wisemandle W, Shintani A, Ely EW. Delirium
precluded subgroup analysis to identify potential moderating fac- duration and mortality in lightly sedated, mechanically ventilated intensive
tors However, the automated voice reorientation intervention care patients. Crit Care Med. 2010;38(12):2311e2318.
7. Gunther ML, Morandi A, Krauskopf E, Pandharipande P, Girard TD,
demonstrated a statistically significant effect, and these data pro- Jackson JC, et al. The association between brain volumes, delirium dura-
vided preliminary results for a larger randomized controlled trial tion, and cognitive outcomes in intensive care unit survivors: the VISIONS
(NIH R01 NR016702; ClinicalTrials.org identifier NCT03128671). cohort magnetic resonance imaging study*. Crit Care Med. 2012;40(7):
2022e2032.
Not all subjects in the intervention groups received the maximum 3 8. Morandi A, Rogers BP, Gunther ML, Merkle K, Pandharipande P, Girard TD, et al.
days of intervention. The primary reason for not receiving 3 days of The relationship between delirium duration, white matter integrity, and
intervention was improvement in clinical condition resulting in cognitive impairment in intensive care unit survivors as determined by
diffusion tensor imaging: the VISIONS prospective cohort magnetic resonance
discharge from the ICU, which potentially attenuated the inter- imaging study*. Crit Care Med. 2012;40(7):2182e2189.
vention effect. 9. van den Boogaard M, Schoonhoven L, Evers AW, van der Hoeven JG, van
Achterberg T, Pickkers P. Delirium in critically ill patients: impact on long-term
health-related quality of life and cognitive functioning. Crit Care Med.
Implications for future research and clinical practice 2012;40(1):112e118.
10. Jackson JC, Ely EW. Cognitive impairment after critical illness: etiologies,
risk factors, and future directions. Semin Respir Crit Care Med. 2013;34(2):
While the results of this small study are promising, additional
216e222.
research is needed. Replication in a larger sample is required to 11. Girard TD, Jackson JC, Pandharipande PP, Pun BT, Thompson JL, Shintani AK,
confirm the effect of the intervention. The mechanisms underlying et al. Delirium as a predictor of long-term cognitive impairment in survivors of
the intervention effect have not been elucidated, nor have medi- critical illness. Crit Care Med. 2010;38(7):1513e1520.
12. Wolters AE, van Dijk D, Pasma W, Cremer OL, Looije MF, de Lange DW, et al.
ating factors such as age and gender been explored. Since ICU Long-term outcome of delirium during intensive care unit stay in survivors of
delirium is associated with persistent disability,7e14 future research critical illness: a prospective cohort study. Crit Care. 2014;18(3):R125.
should investigate whether the intervention mitigates long term 13. Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT,
et al. Long-term cognitive impairment after critical illness. N Engl J Med.
problems experienced by ICU survivors. 2013;369(14):1306e1316.
Although no recommendation for changes in clinical practice 14. Brummel NE, Jackson JC, Pandharipande PP, Thompson JL, Shintani AK,
can be made without additional research, the potential to augment Dittus RS, et al. Delirium in the ICU and subsequent long-term disability among
survivors of mechanical ventilation*. Crit Care Med. 2014;42(2):369e377.
information provided by clinical providers with automated mes- 15. Al-Qadheeb NS, Balk EM, Fraser GL, Skrobik Y, Riker RR, Kress JP, et al. Ran-
sages is intriguing. Such messages might be helpful in reducing domized ICU trials do not demonstrate an association between interventions
other symptoms experienced by patients in the ICU, including that reduce delirium duration and short-term mortality: a systematic review
and meta-analysis. Crit Care Med. 2014;42(6):1442e1454.
anxiety about the unfamiliar ICU environment. The differential ef-
16. Hsieh SJ, Ely EW, Gong MN. Can intensive care unit delirium be prevented and
fect of family voice supports the importance of involving family reduced? Lessons learned and future directions. Ann Am Thorac Soc.
members in care of ICU patients. Finding meaningful ways to 2013;10(6):648e656.
17. Grap MJ, Blecha T, Munro C. A description of patients’ report of endotracheal
engage families may result in better outcomes for both patients and
tube discomfort 6034. Intensive Crit Care Nurs. 2002;18(4):244e249.
families. 18. Granja C, Lopes A, Moreira S, Dias C, Costa-Pereira A, Carneiro A. Patients’
recollections of experiences in the intensive care unit may affect their quality
Conclusion of life. Crit Care. 2005;9(2):R96eR109.
19. Roberts BL, Rickard CM, Rajbhandari D, Reynolds P. Factual memories of ICU:
recall at two years post-discharge and comparison with delirium status during
Reorientation through automated, scripted messages reduced ICU admissionea multicentre cohort study. J Clin Nurs. 2007;16(9):1669e1677.
incidence of delirium in critically ill adults. Using identical scripted 20. Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, et al. Delirium in
messages, family voice was more effective in reducing delirium mechanically ventilated patients: validity and reliability of the confusion
assessment method for the intensive care unit (CAM-ICU). JAMA. 2001;286(21):
than an unknown voice. While promising, a more robust exami- 2703e2710.
nation of the effects of this intervention, using rigorous methods in 21. Neto AS, Nassar Jr AP, Cardoso SO, Manetta JA, Pereira VG, Espósito DC, et al.
larger samples, is warranted. Delirium screening in critically ill patients: a systematic review and meta-
analysis. Crit Care Med. 2012;40(6):1946e1951.
The automated reorientation intervention we report here is a 22. Jackson JC, et al. A prospective investigation of long-term cognitive impairment
simple but potentially powerful strategy to provide structured in- and psychological distress in moderately versus severely injured trauma
formation to patients on a regular basis, and its effectiveness is intensive care unit survivors without intracranial hemorrhage. J Trauma.
2011;71(4):860e866.
enhanced when the message is delivered in the voice of a family
23. Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, et al.
member. Because the intervention has a strong nursing care focus, Cognitive trajectories after postoperative delirium. N Engl J Med. 2012;367(1):
it has the potential to affect delirium in ways that are distinct from 30e39.
24. Elliott R, Wright L. Verbal communication: what do critical care nurses say to
but synergistic with medical care, which has focused primarily on
their unconscious or sedated patients? J Adv Nurs. 1999;29(6):1412e1420.
pharmacologic management of delirium. The ease of imple- 25. Finke EH, Light J, Kitko L. A systematic review of the effectiveness of nurse
mentation of this intervention combined with its low cost make it communication with patients with complex communication needs with a
an attractive strategy to reduce risk of delirium in critically ill focus on the use of augmentative and alternative communication. J Clin Nurs.
2008;17(16):2102e2115.
adults. 26. Llenore E, Ogle KR. Nurse-patient communication in the intensive care unit: a
review of the literature. Aust Crit Care. 1999;12(4):142e145.
References 27. Hagland MR. Nurse-patient communication in intensive care: a low priority?
Intensive Crit Care Nurs. 1995;11(2):111e115.
1. APA. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American 28. Green A. An exploratory study of patients’ memory recall of their stay in an
Psychiatric Publishing; 2013. DSM-5. adult intensive therapy unit. Intensive Crit Care Nurs. 1996;12(3):131e137.
2. Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, et al. Clinical practice 29. Lawrence M. The unconscious experience. Am J Crit Care. 1995;4(3):227e232.
guidelines for the management of pain, agitation, and delirium in adult pa- 30. Treolar DM, Nalli BJ, Guin P, Gary R. The effect of familiar and unfamiliar voice
tients in the intensive care unit. Crit Care Med. 2013;41(1):263e306. treatments on intracranial pressure in head-injured patients. J Neurosci Nurs.
3. Zhang Z, Pan L, Ni H. Impact of delirium on clinical outcome in critically ill 1991;23(5):295e299.
patients: a meta-analysis. Gen Hosp Psychiatry. 2013;35(2):105e111. 31. Walker JS, Eakes GG, Siebelink E. The effects of familial voice interventions on
4. Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell Jr FE, et al. comatose head-injured patients. J Trauma Nurs. 1998;5(2):41e45.
Delirium as a predictor of mortality in mechanically ventilated patients in the 32. Tavangar H, Shahriary-Kalantary M, Salimi T, Jarahzadeh M,
intensive care unit. JAMA. 2004;291(14):1753e1762. Sarebanhassanabadi M. Journal of Immunology; 2000.