[page 122] [Emergency Care Journal 2020; 16:8972]
Emergency Care Journal 2020; volume 16:8972
Even if health care professionals should take into account the
active involvement of families in Intensive Care Units (ICUs), lit-
tle research that investigates family member’s contributions to care
and includes its outcomes on both the family itself and the patient
care, is available. The aim of this research project is to assess the
effects of a family engagement program on family members’ satis-
faction and on patients’ well-being and quality of life. A quasi-
experimental study with two non-randomized groups (94 per each
group) will be performed in two general ICUs of an Academic
Italian Hospital. The intervention will be carried out in a single
ICU and it consists of family members’ involvement in the care of
their loved ones by means of bed physical exercises and simple
care tasks. Participants will be evaluated through manifold out-
comes: family satisfaction, assessed with the FS-ICU tool within
48 hours after ICU discharge; patients’ sense of well-being, meas-
ured with a visual analogue scale within 30 minutes after the time
period of a visit; and the quality of life, investigated with the SF-
12 questionnaire within the first 48 hours after admission to ICU,
at three and six months after ICU discharge by telephone. From
July 2020, 188 subjects are going to be enrolled throughout the
year. The latest data will be collected in December 2021 to allow
the completion of the follow-ups of all participants. First, this
study constitutes a significant step in a research agenda aimed at
deepening the nursing sensitive outcomes in ICUs and the quality
of hospital care. Secondly, the results of this study might have the
potential to provide a better understanding of how families may
modify patients’ outcomes and whether family members would
benefit from an involvement program.
The well-being of patients and their relatives is considered fun-
damental in the care of critically ill adult patients and one of the
top five research priorities among intensive care nurses.1The con-
cept of “family engagement” in Intensive Care Unit (ICU) has
expanded to the point where Health Care Professionals (HCPs)
should now consider the role of the family as no longer of passive
consultation, but rather of active involvement.2
A recent scoping review has investigated the extent of litera-
ture on patient and family involvement in ICUs between 2003 and
2014.3The authors identified five components of family participa-
tion, that focused on involvement as: i) being present; ii) receiving
care and meeting needs; iii) communicating and receiving infor-
mation; iv) participating in the decision-making process; and v)
contributing to care.3A more recent clinical review in 2018 has
summarized the concept of “engagement” by defining it as a mech-
anism to take action with people and to share with them informa-
tion and decisions, and a way to achieve patient- and family-cen-
tered care.4In addition, authors designated as “family” each family
member, close relative, and caregiver with whom the patient spent
most of the time.4
Where “family involvement” has been documented, the contri-
butions have primarily considered family’s attendance in ICU
rounds,5-7 followed by the participation in fundamental care, such
as bathing and massaging,8in psychological patients’ care,9in ven-
tilator weaning programs,10 and in research experiences.11
Regarding the outcomes, the family members’ involvement in
the ICU patient care seems to improve patients’ psychological
recovery, well-being, and satisfaction levels,12 while their post-
traumatic disorders and depression were found to be reduced.13
Recently, family engagement in professional care has been recog-
nized as a Nursing Sensitive Outcome (NSO),14,15 that is a patient
or caregiver ’s state, behavior, or perception associated to nursing
interventions.16 Accordingly, assessing family members’ satisfac-
tion should be considered a way to improve the quality of critical
care provided to families of patients in ICU environments.17
To date, little research investigating family members’ contribu-
tions to care in ICUs, including its outcomes on family itself and on
Correspondence: Matteo Danielis, Department of Clinical Sciences and
Community Health, University of Milan, Via Vanzetti, 5 - 20133, Milan,
Key Words: family engagement; intensive care unit; critical care;
patient and family outcomes; experimental study.
Ethical Committee: This protocol was approved by the Regional Ethics
Committee of the Friuli Venezia Giulia, Italy (CEUR-2020-Sper-012).
Trial registration: ClinicalTrials.gov, Identifier: NCT04311190.
Registered on March 17, 2020. Available from: https://clinicaltrials.gov/
Conflict of interest: No one. This work was not supported by any grant.
Ethics approval and consent to participate: The manuscript does not
contain any individual person's data in any form.
Received for publication: 19 March 2020.
Accepted for publication: 27 May 2020.
This work is licensed under a Creative Commons Attribution 4.0
License (by-nc 4.0).
©Copyright: the Author(s), 2020
Licensee PAGEPress, Italy
Emergency Care Journal 2020; 16:8972
Family ENgagement in Intensive Care Environments (FENICE):
A quasi-experimental study protocol
Matteo Danielis,1,2 Alvisa Palese,2Stefano Terzoni,3Anne Destrebecq4
1Department of Clinical Sciences and Community Health, University of Milan, Milan; 2Department of
Medical Sciences, University of Udine, Udine; 3School of Nursing, San Paolo Hospital, Milan; 4Department
of Biomedical Sciences for Health, University of Milan, Milan, Italy
Non commercial use only
patient care, is available.3We hypothesized that engaging families in
the care of critically ill patients could improve outcome both at fam-
ily and at patient levels. Thus, the aim of this project is to assess the
effects of a family engagement program on family members’ satis-
faction and on patients’ well-being and Quality of Life (QoL).
Materials and Methods
Research hypothesis and expected outcomes
i) At family level: Families of critically ill patients in the family
engagement group will show a higher general satisfaction as
compared to those families in the control group.
ii) At patient level: The family-involved patients’ group will show
a) an increased sense of well-being after the daily visiting peri-
od, and b) a better QoL after ICU discharge (three and six
months) as compared than the control group.
A quasi-experimental study with two non-randomized groups
will be performed by following the CONSORT (CONsolidated
Standards Of Reporting Trials) guidelines.18 Figure 1 shows the
CONSORT flow diagram corresponding to the present study.
This study will be conducted in two general ICUs of an
Academic Hospital in the Northeast of Italy equipped with 900
beds. ICU A and B (beds = eight/each) provide care for both ven-
tilated and non-ventilated patients and mixed medical, surgical,
and trauma patients admitted directly through the Emergency
Department (ED) or other hospital wards. Each ICU environment
is a traditional open space, in which beds are separated by curtains.
Staff is composed of Registered Nurses (RNs), with a nurse-to-
patient ratio of 1:2, Medical Doctors (MD) and Nursing Assistants
(NAs). Generally, the average ICU Length Of Stay (LOS) is 5.0
days and the average ICU occupancy rate is 80.2%.
Sampling and sample
This study will involve two groups of family members of
patients who will be admitted to two ICUs. Specifically, in the
intervention group, family members will be actively involved in
the care of their relative; in the control group, patients will receive
the usual care provided only by the nurses. Given the setting of the
ICUs, with one open space shared by patients and visitors, partici-
pant randomization is not feasible. Moreover, to reduce the risk of
inter-group contamination, ICU-A will be assigned to the interven-
tion group and ICU-B to the control group.
A consecutive sampling method will be adopted to recruit the
expected family members of adult patients (≥18 years) in both the
intervention and the control groups in the same period, from July
2020 to June 2021. Inclusion and exclusion criteria for the study
population are shown in detail in Table 1. Patients’ withdrawal cri-
teria will be as follows: discharge from ICU, transfer to another
hospital, or death. The withdrawal criterion for family members
will be the unexpected suspension of daily visiting.
Figure 1. Flow chart of the study protocol.
[Emergency Care Journal 2020; 16:8972] [page 123]
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[page 124] [Emergency Care Journal 2020; 16:8972]
Sample size calculation
The sample size calculation is based on the target population of
the study, which is composed of family members. Yet, no studies
have evaluated the specific effect of the implementation of a fam-
ily involvement program in ICUs on family’s’ perceived satisfac-
tion. However, previous studies estimated the effect of structured
communication and support programs on the satisfaction of family
members of critically ill patients with the FS-ICU tool,19,20 in
which the mean of FS-ICU total score before intervention was 55.3
(± 10.3) and after intervention was 61.4 (± 17.7). Based on this, a
sample of 188 patients (94 per each group) is the adequate require-
ment for the present study. This will result in a mid-scale effect
size of 0.41, at a 5% significance level with a power of 80% and
an allocation rate of 1:1. The sample size of this study was calcu-
lated with the software G*Power (version 126.96.36.199).21 Thus, each
family member will be included together with his/her loved one
who is being taken care for in ICU (94 per each group).
Despite light sedation being considered a routine therapy in the
ICU settings of this study, a variety of reasons, including neurolog-
ical, physiological, and communicative disabilities, can prevent
patients’ accurate estimation of their well-being by means of self-
reported measures. This group of patients may include uncon-
scious, deeply sedated and intubated patients, as well as those with
a cognitive impairment or a head and maxillofacial trauma. For
this reason, the researchers could not extend the sample size eval-
uation to the patient’ well-being outcome.
Intervention and control group
The intervention will be carried out in a single ICU (ICU-A) and
will engage family members in the care of their loved one with bed
physical exercises and simple care tasks, as reported in Table 2.
Trained nurses will provide families with written and verbal informa-
tion about their involvement in the above-mentioned care activities
(day 1: patient’s admission to ICU) and will strictly supervise their
engagement during the daily visiting hours (from day 2 to the trans-
ferring into another unit/ward). No intervention will be implemented
without the approval of nurses and physicians who daily evaluate
patients’ conditions. Each session of family involvement will last for
at least one hour per patient/day. In the case of signs of respiratory,
hemodynamic or neurovegetative distress, the session will be imme-
diately suspended by any HCP and the reasons of such decision will
be appropriately communicated to the family member. The interven-
Table 1. Inclusion and exclusion criteria for patients and family members
Adult (18 years of age and older) Pediatric population (< 18 years old)
If patient meets any of the following criteria:
Expected to stay in ICU at least three days to ensure adequate - Unsafe airways
exposure to ICU environment Airways - Hypoventilation/hyperventilation
Suffering from either high or low acuity conditions - PaO2/FiO2< 200mmHg
Breathing - pH < 7.30
- SpO2< 92%
- Respiratory rate > 35/min
- Heart rate < 50/min
- Heart rate > 130/min
Circulation - Mean arterial pressure between 60 to 80 mmHg
- Having mechanical heart/blood pressure support
(e.g. intra-aortic pump balloon)
- Intense diaphoresis
- Prone position
- Intracranial pressure monitoring
Disability - Hypersensitivity to touch (e.g. epileptic status)
- Psychomotor agitation or anxiety status (e.g. RASS
scores +1 to +5)
- Suppurating/infective/inflammatory/burned skin conditions
Exposure - Unstable fractures
- Peripheral intravenous line on the hands
- Terminally ill conditions
Adult (18 years of age and older) Pediatric population (< 18 years old)
Being the patient’s spouse, or in a blood relation, or next of kin, Lack of propensity or interest in participating in the study
and/or a person with whom the patient spends most of the time
Willing to visit the patient daily
Willing to participate in the study
RASS = Richmond Agitation Sedation Scale.
Non commercial use only
tion group will be formed of maximum eight patients, corresponding
to the ICU-A bed availability. In the ICU-B, patients will receive the
usual care consisting of a once-daily visit of at least one hour by fam-
ily members without their formal involvement in simple care.
Family members’ recruitment and involvement
Table 3 illustrates the recruitment and the involvement
processes for family members.
Data collection and measurements
All data will be collected daily by two researchers (MD, AP),
together with the nursing and medical staff of the Department of
Anaesthesia and Intensive Care, and professionally trained med-
ical and nursing students. Data collection will include both clinical
information and paper-based questionnaires. The anonymized
paper data will be stored by the researchers (see authors) of the
Sociodemographic and clinical data
At the time of admission to ICU, within the routinely admis-
sion assessment, patients’ demographics (age, gender), clinical
characteristics (diagnosis, comorbidities, Glasgow Coma Scale
[GCS] and Richmond Agitation-Sedation Scale [RASS] scores),
anthropometric measures (weight and height, both required to cal-
culate the Body Mass Index [BMI]), and previous habits (e.g., cig-
arette smoking) will be assessed. Simultaneously, the family mem-
ber’s information, including age, gender, education, relation to
patient and profession, will be collected with an ad hoc form.
Every day, each activity performed by the family member in
the intervention group will be recorded in a pre-established form.
The grid will report data, time, type of activities, and their duration
(in minutes). In case of clinical deterioration during the interven-
tion, this will be immediately stopped by the nurse and/or physi-
cian in charge of the patient’s care. The intervention group will be
formed of maximum eight patients, corresponding to the ICU-A
At family level: Family satisfaction, assessed with the FS-ICU
tool,22,23 will be self-reported by family members within 48 hours
after a patient’s discharge from ICU.
At patient level: i) A patient’s sense of well-being will be
measured with a visual analogue scale (VAS) within 30 minutes
after the family involvement for the intervention group and in the
same span of time after the ICU visiting hours for the control
group;24 ii) The QoL will be investigated with the SF-1225 ques-
tionnaire within the first 48 hours after admission to assess pre-
admission QoL,26 at three and six months after ICU discharge by
telephone (patient or family members).
The FS-ICU questionnaire includes 24 items; 14 inquire about
families’ satisfaction with care and 10 explore their satisfaction
with decision-making.22 All items are scored on a five-point Likert
scale (from 1=very dissatisfied to 5=very satisfied) except one
item which is dichotomous (yes/no). All questions included the
Table 2. Family involvement: care activities
High acuity patients Low acuity patients
(when a patient is mechanically ventilated and under analgosedation) (when a patient is awake and collaborative)
Open and close the fingers Massages
Open and close the toes Arms and legs position changes
Physical presence with touch at least 60 minutes/day Washing face
Hair brushing Assisting with rehabilitation exercises
Reading texts of interest to the patient (e.g., newspapers) Encouraging/assisting with eating and drinking under nurses’ strict
Table 3. Details of the intervention protocol
Step 1 – Day one (patient’s admission to ICU)
The researcheraverifies if the patient meets the inclusion criteria.
If yes, the researcheraproceeds with step 2.
Step 2 – Day one (family members’ first visit to the ICU)
The researcheraverifies if the family member meets the inclusion criteria.
If yes, the researchera provides information about the intervention (including how to talk to the patient, advice on where to sit or stand at the bedside and on
how to open and close the interaction, as well as on the activities in which family members can be involved). The education session will last at least half an
hour. Moreover, the researchera discusses the study details with the family, identifies with them a family member as a reference, and ascertains decisions
If the written consent is provided, data collection starts with step 3.
Step 3 – Day two to transfer to ward (during the ICU-stay)
The researcheraactively seeks opportunities to promote the family access to the patient, maximizing the time available for the family to be with s/he and
encouraging them to interact by talking and holding the patient’s hand. In addition, the researcherapromotes the implementation of the activities described in
Table 2 by recording them in the ad hoc grid.
On daily basis, the researcheraevaluates both the availability of the family member to participate, and the patient’s clinical conditions before engaging the
family member. Furthermore, the researcherasupervises all activities performed by the family member and provides feedback of encouragement.
ICU = Intensive Care Unit. a the authors and/or a member of the research team.
[Emergency Care Journal 2020; 16:8972] [page 125]
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[page 126] [Emergency Care Journal 2020; 16:8972]
“not applicable” optional response. Data will be collected from all
participants via self-administered questionnaires (written).
Originally developed from the Medical Outcomes Study
(MOS) 36-item Short-Form Health Survey (SF-36), the SF-12 tool
consists of 12 questions and measures eight domains: physical
functioning, role-physical, bodily pain, general health, vitality,
social functioning, role-emotional, and mental health.25,27 A score
ranging from 0 (indicating the worse health status) to 100 (the best
health status) is assigned to each domain. Domain scores can be
summarized into a Physical Component Score (PCS) and Mental
Component Score (MCS). Data will be collected on all participants
via a combination of self-administered questionnaires (written)
during the ICU-stay and telephone interviews post-discharge.
Collected data will be entered into a Microsoft Excel® work-
sheet. All statistical analysis will be performed using the SPSS
software version 25 (SPSS Institute Inc., USA) and the statistical
significance set at p<0.05. Continuous variables (e.g. age, LOS)
will be displayed as mean and Standard Deviation (SD) if normally
distributed or median and quartiles otherwise. Normality will be
assessed by using the Kolmogorov-Smirnov test. Nominal vari-
ables (e.g. gender, reason of admission) will be calculated as
absolute numbers and percentage. Student’s unpaired t-test will be
used to analyze comparisons between means; Blom’s transforma-
tion will be used if normality test fails. Categorical variables will
be analyzed using the chi-squared test for independence. A conti-
nuity-corrected chi-squared statistic or Fisher’s exact test to evalu-
ate the null hypothesis of this study in case of expected frequencies
<5 in contingency tables will be applied. Moreover, the scores of
FS-ICU and SF-12 obtained from the two groups will be examine
using the analysis of covariance (ANCOVA).
Once half of the sample is reached (47 per each group), an ad
interim analysis will be performed to assess i) whether the inter-
vention is feasible in terms of family members acceptability and
willingness to participate in the study, and ii) whether a statistically
significant difference regarding family satisfaction between groups
is already noticeable (p-value set to 0.05). According to the results
(e.g., study dropout rates and consent refusal, treatment difference
larger or smaller than expected), the intervention and/or sample
size calculation will be changed, and a new research protocol will
be developed. However, this study has not stopping rules.
The current study will be conducted according to the criteria
set by the declaration of Helsinki; each patient legally authorizes a
representative and/or a family member will provide written
informed consent for all study procedures. Family members will be
informed about withdrawing from the study at any time without
affecting the care provided. The participants’ privacy and personal
information will be protected, and data will be anonymously ana-
lyzed. In addition, both ICUs are equipped to ensure patients’ pri-
vacy during the visiting and intervention time (e.g. large spaces,
beds separated by curtains). Lastly, this protocol was approved by
the Regional Ethics Committee of the Friuli Venezia Giulia
Beginning from July 2020, 188 subjects are going to be
enrolled throughout the year. The latest data will be collected in
December 2021 to allow the completion of the follow-ups of all
To our best knowledge, very few works19,20 have studied the
relationship between engaging families’ interventions and NSOs in
ICUs. This protocol constitutes a significant step in a research
agenda aimed at deepening the NSOs’ reliability across the ICUs
and useful to proxy monitoring the quality of hospital care. The
results of this study might have the potential to provide additional
evidence for family participation in bedside care in ICUs, and a
better understanding of how family members and critically ill
patients may benefit from the involvement itself.
Regarding dissemination, the results of the present study will
be firstly presented and discussed at professional meetings by con-
ducting a stakeholders’ consultation. Then, research findings will
be disseminated in scientific journals and at national and interna-
Despite international bodies prioritizing the well-being of fam-
ilies and patients in ICU, current literature lacks practical under-
pinnings and examples to promote the involvement of family in the
care of the critically ill patients. This study protocol aimed at
examining the effect of a family engagement program on NSOs at
both family- and patient-level. The results may provide valuable
insight into the quality of care delivered. ICU nurses and physi-
cians need to become convinced that families can be routinely
involved in care activities; family engagement can optimize
patients’ outcomes including well-being and quality of life, and
increase family satisfaction with care in ICU.
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