Heart & Lung xxx (2017) 1e5
Contents lists available at ScienceDirect
Heart & Lung
journal homepage: www.heartandlung.org
Delirium prevention in critically ill adults through an automated
reorientation intervention e A pilot randomized controlled trial
Cindy L. Munro, PhD, NP, RN a, *, Paula Cairns, MSN, RN a, Ming Ji, PhD a,
Karel Calero, MD b, W. McDowell Anderson, MD b, Zhan Liang, PhD, RN a
a
b
University of South Florida College of Nursing, 12901 Bruce B. Downs Blvd, MDC 22, Tampa, FL 33612-4766, USA
University of South Florida Morsani College of Medicine, 12901 Bruce B. Downs Blvd, MDC 19, Tampa, FL 33612-4766, USA
a r t i c l e i n f o
a b s t r a c t
Article history:
Received 26 October 2016
Received in revised form
4 May 2017
Accepted 5 May 2017
Available online xxx
Objectives: Explore the effect of an automated reorientation intervention on ICU delirium in a prospective
randomized controlled trial.
Background: Delirium is common in ICU patients, and negatively affects outcomes. Few prevention
strategies have been tested.
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 nonfamily voice, and 10 (control) did not receive any automated reorientation messages. The primary
outcome was delirium free days during the intervention period (evaluated by CAM-ICU). Groups were
compared by Fisher’s Exact Test.
Results: The family voice group had more delirium free days than the non-family voice group, and
significantly more delirium free days (p ¼ 0.0437) than the control group.
Conclusions: Reorientation through automated, scripted messages reduced incidence of delirium. Using
identical scripted messages, family voice was more effective than non-family voice.
Ó 2017 Elsevier Inc. All rights reserved.
Keywords:
Delirium
Intensive care unit
Family
Delirium prevention
Nursing care
Critical illness
Delirium intervention
Introduction
Delirium is an acute disturbance in attention and awareness,
with additional change in cognition from the person’s baseline.1
Delirium develops over a short period of time and may fluctuate
over the course of the day. Critically ill patients are at high risk for
delirium, with 50% of ICU patients and as many as 80% of
mechanically ventilated patients experiencing delirium.2 Metaanalyses indicate that patients with delirium have greater incidence of complications including nosocomial pneumonia, longer
duration of mechanical ventilation, longer hospital length of stay,
and higher hospital mortality than patients without delirium.3
Number of days of delirium has been identified as an independent predictor of mortality in ICU patients.4e6 Delirium in critical
illness is estimated to cost $4 to $16 billion annually.2
Importantly, delirium in the ICU not only complicates the
hospital course, but it is also associated with lasting sequelae.7e10
Data suggest that 25%e78% of patients who have delirium in the
ICU suffer clinically significant declines in cognitive function
* Corresponding author.
E-mail address: cmunro2@health.usf.edu (C.L. Munro).
0147-9563/$ e see front matter Ó 2017 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.hrtlng.2017.05.002
following their ICU stay.11,12 Cognitive dysfunction may persist
for months or be permanent,9,11,13 and is associated with
impairments in daily function.14 In recent studies, increasing
duration of delirium was an independent predictor of worse
cognition 3 months and 12 months after ICU discharge,11,13 and
this remained true even after adjusting for risk factors such as
age, severity of illness, severe sepsis, and exposure to sedative
medications in the ICU.11
To date, the focus of delirium research has been on detection of
existing delirium and on its pharmacologic treatment.15 Prevention
of delirium using a non-pharmacologic intervention has not been
well examined. Interventions that assist critically ill patients to
integrate information more appropriately may decrease delirium
and improve outcomes,16 but have not been rigorously tested. We
reasoned that providing ongoing orientation to the ICU environment through recorded messages might enable the patient to more
accurately interpret the environment and thus reduce risk of
delirium, and that cuing patients only during daytime hours might
also improve day/night orientation, further reducing risk of
delirium.
We developed a cognitive reorientation intervention which uses
automated recorded audio messages, played at hourly intervals
during daytime hours, to provide information about the ICU
2
C.L. Munro et al. / Heart & Lung xxx (2017) 1e5
Enrollment
Assessed for eligibility
(n = 40)
Excluded:
Did not meet criteria (n = 8)
Unable to obtain consent (n = 2)
Analysis
Allocation
Patient enrolled and randomized to group assignment (n = 30)
Group 1 - intervention
Unknown voice recorded reorientation
message (n = 10)
Group 2 - intervention
Family member voice recorded reorientation
message (n = 10)
Group 3 - usual care
No recorded reorientation message
(n = 10)
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:
Early icu discharge (n = 4)
Off the unit for testing (n = 1)
Transferred to palliative care (n = 0)
Death (n = 0)
Did not receive full intervention:
Early icu discharge (n = 6)
Off the unit for testing (n = 0)
Transferred to palliative care (n = 1)
Death (n = 0)
Did not receive full usual care:
Early icu discharge (n = 3)
Off the unit for testing (n = 0)
Transferred to palliative care (n = 0)
Death (n = 1)
Analyzed (n = 10)
Analyzed (n = 10)
Analyzed (n = 10)
Excluded from analysis (n = 0)
Excluded from analysis (n = 0)
Excluded from analysis (n = 0)
Fig. 1. CONSORT study flow.
environment to the patient. We thought that messages delivered in
a voice familiar to the patient might result in greater attention to
the messages and be comforting. This study tested the hypothesis
that providing ongoing orientation to the ICU environment through
recorded audio messages would reduce risk of delirium in critically
ill adults; both familiar voices (family voice) and an unfamiliar
voice (unknown voice) were tested against no recorded voice
(control).
Methods
A three group, prospective, randomized controlled trial (RCT)
design was used to examine the effects of the automated reorientation intervention on delirium. Ten subjects were randomized
to receive automated reorientation messages in a family member’s
voice (family voice group), ten subjects received the same messages
in an unfamiliar voice (unknown voice group) and ten subjects
(control group) did not receive any automated reorientation messages. The study CONSORT diagram is presented as Fig. 1.
Human subjects protection
The study was approved by the hospital where data were
collected and by the Institutional Review Board of the university.
Signed consent was obtained from subjects or their legally authorized representatives. Twelve subjects provided consent for
themselves, and consent was obtained from legally authorized
representatives for the 18 subjects who were unable to consent for
themselves.
Sample
Subjects were eligible if they were over 18 years old and within
24 h of ICU admission. Exclusion criteria included anticipation by
the clinical provider of imminent patient death, medical contraindication to the intervention (for example, psychiatric auditory
hallucinations, or profound deafness), or inability to speak either
English or Spanish. Subjects were recruited in 5 ICUs in a large
urban level I trauma center in the Southeastern United States. A
total of 30 subjects were randomized into 3 groups by the biostastician co-investigator (MJ) prior to the first enrollment using a
computerized random number generator.
Automated reorientation intervention
Intervention development
A draft script of reorientation messages was developed based on
published research by our team and others about patients’ recall of
ICU experiences.17e19 The script was refined based on reviews of 3
critical care experts, and further adjustments to message volume,
length, and speaker location were made following input from
healthy nurse volunteers in the ICU setting. The original script was
developed in English; a Spanish version was translated from English by a certified medical translator and back-translated.
Message description
Each message was scripted, was no longer than 2 min long,
included the subject’s name (preferred name as recommended by
the subject’s family), and used simple terms at a 5th grade
reading level. Other than the subject’s name, the recorded message was not specific to any patient condition, procedure, or
family situation. Each message was delivered only during daytime
hours (to provide general time orientation), stated that the
message was recorded, and reoriented the subject frequently
throughout the day to help them understand they were in the
ICU. Additional message elements followed in random order, and
provided information about the critical care environment, the
visual and auditory stimuli to be expected, and the availability of
providers and family. Random ordering of elements within the
recorded message at each delivery was designed to reduce message repetition. The elements of the reorientation message are
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
research staff person (for the unknown voice group). Selection of
the English or Spanish script was based on the family’s decision
regarding which language would be most meaningful to the subject. The messages were digitally recorded through a sound card
and stored as a standard Microsoft wave file.
Intervention delivery
At predetermined time intervals over 3 days in the ICU (every
hour for 8 h during the daytime hours, beginning at 9:00 am and
ending at 4:00 p.m.), a recorded message was played back in the
patient’s room through the room’s television audio system. The
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
waking hours, so as not to disturb sleep or interrupt family visits in
the evening hours. Intervention began at the earliest available
daytime hour following completion of family or staff recording.
Subjects received a maximum of 24 recorded messages (8 messages
per day for 3 days). Instances where the message was not delivered,
for example when the subject was off the unit for procedures, were
noted. The intervention ended if the subject was discharged from
the ICU during the study period. The number of messages delivered
was summed for each subject, and group means were calculated.
Delirium
The primary outcome for the study was delirium free days.
Delirium was evaluated twice daily (prior to initiation of and
following completion of the intervention administration) using the
Confusion Assessment Method (CAM)emodified ICU version.20 For
this research study, CAM-ICU determinations were made by the
research nurse (PC) who is an experienced critical care RN trained
in CAM-ICU administration. The CAM-ICU was developed for use by
clinical providers who are not psychiatrists. Four features are
evaluated as present or absent using standardized methods: 1)
acute onset or fluctuating course, 2) inattention, 3) altered level of
consciousness, and 4) disorganized thinking. A patient is assessed
to have delirium only if features 1 and 2 are both present with
either feature 3 or 4 also present. The CAM-ICU is recognized in the
Society for Critical Care Medicine’s Clinical Practice Guidelines for
the Management of Pain, Agitation, and Delirium in adult patients
in the ICU settings as a valid, reliable, and feasible tool to detect
delirium in ICU patients.2 A systematic review of 16 research
studies involving 1523 participants using five screening tools
concluded that the CAM-ICU was the most specific bedside tool for
the assessment of delirium in critically ill patients, with pooled
sensitivity of 75.5% and specificity of 95.8%.21
When CAM-ICU criteria for delirium were not met (negative
result) for either of the assessments for a study day, and no clinical
providers had documented intervening delirium, the day was
counted as a delirium free day. Mean days of delirium, where at
least one assessment indicated that CAM-ICU criteria were met
(positive result) on the study day, were also calculated for each
group.
Sample characteristics
In order to assess group equivalence and identify potential
covariates, demographic data were collected, including sex,
ethnicity, race, and age. In addition, baseline data about severity of
illness and comorbidities were collected using the APACHE III
scoring system, calculated on the most deranged values during the
first 24 h of ICU admission.
Analysis
All enrolled subjects were analyzed. Descriptive statistics were
produced to describe the 3 groups and to compare their characteristics (see Table 2). Groups were equivalent by ANOVA (including
positive CAM-ICU at study admission and days in ICU) and no adjustments of covariates were needed. A Fisher’s Exact Test at
Table 2
Sample characteristics.
Variable
Sex % (n)
Male
Female
Ethnicity % (n)
Hispanic
Non-hispanic
Race % (n)
White
Black
Age in years, mean (SD)
Positive CAM-ICU at study admission (n)
APACHE score, mean (SD)
Days on mechanical ventilation, mean (SD)
Days in ICU, mean (SD)
Total sample
(30)
Subjects by group
Family voice
Non-family voice
Control
63.3 (19)
36.7 (11)
60 (6)
40 (4)
60 (6)
40 (4)
70 (7)
30 (3)
10 (3)
90 (27)
20 (2)
80 (8)
0 (0)
100 (10)
10 (1)
90 (9)
83.3 (25)
16.7 (5)
59.5 (17.0)
4
63.6 (20.7)
2.1 (5.5)
5.0 (5.9)
100 (10)
0 (0)
58.8 (14.2)
1
68.9 (12.4)
0.8 (0.8)
3.0 (1.6)
70 (7)
30 (3)
57.0 (12.1)
1
59.7 (23.8)
4.1 (9.0)
7.1 (9.4)
80 (8)
20 (2)
62.6 (23.9)
2
62.2 (24.7)
1.2 (2.7)
4.9 (3.5)
4
C.L. Munro et al. / Heart & Lung xxx (2017) 1e5
Table 3
Delirium assessments.
Delirium free days, mean (SD)
Mean days of delirium (SD)
Family voice
Unknown voice
Control
1.9 (0.99)
0.3 (0.48)
1.6 (1.07)
0.6 (0.84)
1.6 (1.13)
0.9 (1.28)
p < 0.05 for the number of delirium free days and the treatment
assignment was performed to test the primary hypothesis. We did
not make any adjustments for total duration of the intervention;
not receiving the full 3 days of intervention attenuates the intervention effect, and we conservatively chose not to adjust in this
small sample.
Results
Sample demographics and clinical characteristics
The sample was 63% male, ranged in age from 19 to 92 years old
(mean 59.5, SD 17.0), and had a mean APACHE severity of illness
score of 64 (SD 20.7). Because we recruited from 5 ICUs (including
Medical ICU, Cardiothoracic ICU, Vascular ICU, Surgical Trauma ICU,
and Medical Respiratory ICU), there were a wide variety of admitting diagnoses; analysis was not performed for diagnosis or comorbidity subgroups. Eighteen of the 20 intervention subjects
received messages in English, and 2 of the 20 intervention subjects
received the messages in Spanish. Additional characteristics of the
sample by group are presented in Table 2.
Intervention delivery
The mean number of messages delivered did not differ between
the unknown voice group and the family voice group. The mean
number of messages received by the unknown voice group was
20.3 (SD 6.25). The mean number of messages received by the
family voice group was 19.8 (SD 5.16).
Delirium free days and means days of delirium between groups
During the three day intervention period, mean delirium free
days were 1.9 in the family voice group, 1.6 in the unknown voice
group and 1.6 in the control group (Table 3). Mean days of delirium
were 0.3 in the family voice group, 0.6 in the unknown voice group,
and 0.9 in the control group. To test the association between
number of delirium free days and groups, we performed a contingency table analysis which yielded a Fisher’s Exact Test p value of
0.0437, indicating a significant difference among groups on number
of delirium free days. Although the descriptive statistic of mean
days of delirium showed a decreasing trend across the control, the
unknown voice and family voice groups, the differences were not
statistically significant.
Discussion
The major finding of our study was that patients in the family
voice group had significantly more delirium free days than the
control group. Mean delirium days were less in the family voice
group than the unknown voice group or the control group,
although the differences were not significant in this small sample.
Our study is the first randomized controlled trial to examine the
effects of using an automated reorientation intervention to prevent
delirium among ICU patients.
Delirium is a common manifestation of cognitive dysfunction in
critically ill patients which is associated with substantial negative
outcomes both during and following hospitalization. A recent
meta-analysis concluded that compared to patients without
delirium, patients with delirium were six times more likely to
experience complications, had longer duration of mechanical
ventilation, longer ICU length of stay, and longer hospital length of
stay.3 Furthermore, patients who experience delirium have problems with cognitive function and health status after hospital
discharge, which have been documented at 3 and 12 months and
may persist indefinitely.13,22,23
Because of the extensive incidence and significant negative
outcomes associated with delirium, identification of effective
interventions to prevent or reduce delirium is critically important. The Society of Critical Care Medicine, in its most recent
guidelines for managing pain, agitation, and delirium in the
critically ill adult,2 recommended routine assessment for
delirium in the ICU.
As a result of trends toward lighter sedation, most patients are
aware of the ICU surroundings and require consistent and frequent
reorientation to all aspects of their care. Reorientation may
enhance patients’ feelings of security and comfort, allow them to
more accurately interpret these stimuli, and ultimately reduce
delirium. However, communication with sedated or nonresponsive critically ill patients is often not optimal24e26 and is
often considered to be a low priority in the ICU setting.27 A review
of nurse-patient communication in the ICU found that nurses
communicate poorly with patients, despite a high level of
knowledge and skill with respect to communication. High stress
levels and preoccupation with physical care and technology are
potential explanations.26 Although most critically ill patients are
sedated and many appear nonresponsive, several studies have
documented that patients hear, understand and respond
emotionally to what is being said even when healthcare providers
assumed they were not aware.28,29 In interviews 48 h after ICU
discharge, patients were not able to recall their nurse’s name, but
did recall detailed explanations given to them by nurses.28 Automated messages about the ICU environment can provide consistency of information, augment the communication provided by
nurses at the bedside, and may enhance the critically ill patient’s
feelings of comfort. Inclusion of the patient’s name in the automated reorientation message may create greater attention to the
message.
Providing reorientation through scripted, automated, recorded
messages may mitigate the reduction of orientation to the
environment, which is a central feature of delirium, and reduce
the occurrence of delirium. In our study, messages recorded in a
family member voice familiar to the critically ill subject were
particularly effective. Several small studies have evaluated the
safety of messages recorded by family on head injured comatose
patients.30e32 Walker and associates31 investigated the effects of
taped messages by a family member on physiological functioning in a convenience sample of 10 comatose patients. The
findings support family interaction via family voice taped messages was safe, even though no significant differences were
observed. Tavangar and colleagues32 examined the effects of
family members’ voice on level of consciousness in 40 comatose
patients. There was a significant difference between the mean
daily GCS scores in two groups (p ¼ 0.003), indicating that
family members’ voice can increase level of consciousness of
comatose patients. However, none of these studies have assessed
delirium and non-comatose patients. Our study using recorded
family voice to improve orientation and reduce delirium is a
novel approach which has not been previously described in the
research literature nor considered in recent clinical guidelines;
the data in our small randomized trial of 30 subjects supports
beneficial effects of the intervention on reducing delirium
occurrence.
C.L. Munro et al. / Heart & Lung xxx (2017) 1e5
Limitations
The sample size of this study was small. The small sample size
precluded subgroup analysis to identify potential moderating factors However, the automated voice reorientation intervention
demonstrated a statistically significant effect, and these data provided preliminary results for a larger randomized controlled trial
(NIH R01 NR016702; ClinicalTrials.org identifier NCT03128671).
Not all subjects in the intervention groups received the maximum 3
days of intervention. The primary reason for not receiving 3 days of
intervention was improvement in clinical condition resulting in
discharge from the ICU, which potentially attenuated the intervention effect.
Implications for future research and clinical practice
While the results of this small study are promising, additional
research is needed. Replication in a larger sample is required to
confirm the effect of the intervention. The mechanisms underlying
the intervention effect have not been elucidated, nor have mediating factors such as age and gender been explored. Since ICU
delirium is associated with persistent disability,7e14 future research
should investigate whether the intervention mitigates long term
problems experienced by ICU survivors.
Although no recommendation for changes in clinical practice
can be made without additional research, the potential to augment
information provided by clinical providers with automated messages is intriguing. Such messages might be helpful in reducing
other symptoms experienced by patients in the ICU, including
anxiety about the unfamiliar ICU environment. The differential effect of family voice supports the importance of involving family
members in care of ICU patients. Finding meaningful ways to
engage families may result in better outcomes for both patients and
families.
Conclusion
Reorientation through automated, scripted messages reduced
incidence of delirium in critically ill adults. Using identical scripted
messages, family voice was more effective in reducing delirium
than an unknown voice. While promising, a more robust examination of the effects of this intervention, using rigorous methods in
larger samples, is warranted.
The automated reorientation intervention we report here is a
simple but potentially powerful strategy to provide structured information to patients on a regular basis, and its effectiveness is
enhanced when the message is delivered in the voice of a family
member. Because the intervention has a strong nursing care focus,
it has the potential to affect delirium in ways that are distinct from
but synergistic with medical care, which has focused primarily on
pharmacologic management of delirium. The ease of implementation of this intervention combined with its low cost make it
an attractive strategy to reduce risk of delirium in critically ill
adults.
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