MISS WARDA RAMADAN ABOUZEID MOHAMED (Orcid ID : 0000-0002-0117-3566)

Article type : Original Article

Accepted Article
The effectiveness of clinical pathway directed care on
hospitalisation-related outcomes in patients with severe
traumatic brain injury: a quasi-experimental study

Warda Ramadan Abouzeid Mohamed*, BN(Hons), MSN,

Visiting International Research (PhD) Student, University of South Australia, Australia;
Assistant Lecturer of Critical Care and Emergency Nursing, South Valley University, Egypt
E-mail: wardarr1199@gmail.com, ramwy002@mymail.unisa.edu.au, Phone: +201067027775

Matthew J Leach, RN, BN(Hons), ND, DipClinNutr, PhD

Senior Research Fellow, Department of Rural Health, University of South Australia, Australia
Email: Matthew.Leach@unisa.edu.au, Phone: +61 8 8302 2846

Nagwa Ahmad Reda, BN, MSN, PhD

Professor of Critical Care and Emergency Nursing, Alexandria University, Egypt
Email: nagwacc@hotmail.com Phone: +2 01001697687

Mohammad Mohamed Abd-Ellatif, BN, MSN, PhD

Professor of Anesthesia, Assiut University, Egypt
Email: Latif_mohamed@hotmail.com Phone: +2 01001745301

Mona Aly Mohammed, BN, MSN, PhD

Assist. Professor of Critical Care and Emergency Nursing, Assiut University, Egypt
Email: mona.ali77@yahoo.com Phone: +2 01226164645

Mervat Anwar Abdel Aziz, BN, MSN, PhD

Assist. Professor of Critical Care and Emergency Nursing, Assiut University, Egypt
Email: anwerabdelziz@yahoo.com Phone: +2 01062384501

*Corresponding author

Funding

The study was not supported by funding from any agency.

This article has been accepted for publication and undergone full peer review but has not
been through the copyediting, typesetting, pagination and proofreading process, which may
lead to differences between this version and the Version of Record. Please cite this article as
doi: 10.1111/jocn.14194

This article is protected by copyright. All rights reserved.

 ABSTRACT
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Background: Severe traumatic brain injury (STBI) is a major cause of disability and

mortality in young adults. Clinical pathways endeavour to bring evidence and clinical

practice closer together to foster the delivery of best practice and to improve patient

outcomes.

Objective: To compare the effectiveness of clinical pathway directed care to usual care on

hospitalisation-related outcomes in patients with STBI.

Design: Quasi-experimental study.

Methods: The study was conducted in a trauma Intensive Care Unit of a large teaching

hospital in Egypt. Patients aged 18–60 years with a diagnosis of STBI, a Glasgow Coma

Scale score between 3 and 8 and a non-penetrating head injury, were consecutively assigned

to 15 days of care. The outcomes assessed were complications related to hospitalization,

clinical variances, length of ICU stay, ICU readmission rate, and patient/family satisfaction.

Results: Sixty participants completed the study (30 in each arm). Apart from age, there were

no significant differences between groups in baseline characteristics. The clinical pathway

group demonstrated statistically significantly fewer cases of hospitalisation-related

complications at day 15, and a significantly shorter length of ICU stay, lower ICU

readmission rate, and a high level of patient/family satisfaction when compared with the

usual care group. The effect of the intervention on fever, pressure ulceration, hyperglycaemia

and re-admission to the ICU was no longer statistically significant after controlling for age.

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 Conclusions: The findings of the current study suggest that the implementation of a clinical

pathway for patients with severe TBI may be helpful in improving the patient experience as
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well as some hospitalisation-related outcomes.

Relevance to clinical practice: The provision of clinical pathway directed care in a trauma

ICU may offer benefits to the patient, family and institution beyond that provided by usual

care

Key words: Care Pathways, Clinical Effectiveness, Evidence-Based Practice, Outcomes,

Patient Satisfaction, Severe traumatic brain Injury

What does this paper contribute to the wider global clinical community?

 The study findings suggest that the provision of clinical pathway directed

care may improve hospitalisation-related outcomes in patients with severe

traumatic brain injury.

 Clinical pathway directed care may also enhance the patient experience

through improvements in care processes, structures and outcomes.

INTRODUCTION
Traumatic brain injury (TBI) is defined as a physiological disruption of brain function and/or

structures caused by a strong impact or a bump to the head (Zasler et al. 2013). It is a leading

cause of morbidity, mortality and disability in young adults throughout the world (Benson,

2016). The management of STBI is complex and usually directed at reducing secondary

complications and maintaining adequate cerebral blood flow (Benson, 2016). Prevention of

these complications is critical to reducing the burden of head injury, although current practice

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 may not necessary reflect best practice (Kreipke & Rafols 2015). Clinical pathways provide

the means to connect the best available evidence with clinical practice; the intention of which
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is to foster the delivery of high quality care and to improve patient outcomes (Haddadsm

2010). Notwithstanding, there is little evidence to date to support this assumption. The study

described herein examines whether evidence-based, clinical pathway directed care is

effective in improving hospitalisation-related outcomes in persons with severe TBI when

compared with usual care.

BACKGROUND
The incidence of traumatic brain injury (TBI) is increasing worldwide; this increase is most

evident in developing countries where there is a significant rise in transport-related head

injuries (Frieden et al. 2015). In Africa, the majority of head and spinal injuries are related to

road traffic accidents. In Egypt in 2010, moderate and severe traumatic brain injury

accounted for 17.2% of all TBI presentations and males represented 79% of all patients

(Montaser & Hassan 2013). In Assiut University Hospital, approximately160 patients are

admitted to the trauma ICU with traumatic brain injury every year. Globally, the Centre for

Disease Control and Prevention estimate 2.5 million hospitalizations and deaths, annually,

are attributed to TBIs, either as an isolated condition or in combination with other injuries

(Frieden et al, 2015).

The World Health Organization (WHO) indicate that traffic accidents will represent the third

greatest cause of disease and injury burden in the world by the year 2020 (Maas et al. 2008)

and TBI will exceed chronic disease in terms of mortality and disability (Benson, 2016).

Adding to the burden of illness/injury is the relatively young age of persons affected by TBI,

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 with most cases likely to occur in children aged less than five years of age and adults aged

between 15–30 years (Roozenbeek et al. 2013)

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The consequences of TBI can be considerable, resulting in loss of consciousness, prolonged

immobilisation, hydrocephalus, skull fracture, cerebral spinal fluid leakage, and infections.

The residual effects of TBI are also significant, including seizures, cognitive impairment (e.g.

thinking, memory, and reasoning), mental heath or behavioural problems (e.g. aggression,

depression, personality changes, anxiety), and neurodegenerative disorders (e.g. dementia of

the Alzheimer's type and Parkinsonism) (Stocchetti & Zanier 2016).

The prolonged period of hospitalisation and immobilisation following the onset of TBI

contributes an additional risk of harm to the patient by promoting the development of

hospitalisation-related complications such as pressure ulceration, systemic or local infections,

hyperthermia, hyperglycaemia, hyper or hypotension and respiratory complications, in

addition to the complications related to head injury. Systemic complications post-traumatic

brain injury may be neurogenic in nature (e.g. the product of an intensecatecholamine, and

neuro-inflammatory response to injury), or an adverse effect of treatment (Rahul et al. 2008).

The presence of hospitalisation-related complications and TBI-related complications can

impact the prognosis of TBI, as can patient age, pertinent medical conditions, and prolonged

secondary brain insult (Zasler et al. 2013). Another factor contributing to the prognosis of

TBI is the severity of the condition. TBI can be classified as mild, moderate or severe; which

is determined by Glasgow Coma Scale (GCS) scoring. Approximately 10% of all head

trauma patients that are still alive on arrival at the emergency department have severe TBI

(Zasler et al. 2013). The presence of severe TBI has important implications in terms of

management and prognosis. For instance, it is predicted that 25% of all patients who have

severe TBI have neurological lesions that require neuro-surgical intervention (Rahul et al.

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 2008). Further, the mortality rate of adult patients with severe head injury is high, around

60%, and most survivors of severe TBI will suffer from severe disability. The effective
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management of TBI and the prevention of hospitalisation-related complications are therefore

critical to improving the prognosis of TBI.

The management of severe TBI is complex, challenging, and often necessitates a multimodal,

standardised approach. This approach generally includes circumspective hemodynamic

monitoring and support, fluid and electrolyte management, respiratory therapy, and other

aspects of care that focus on preventing secondary brain injury, improving cerebral

oxygenation and maintaining adequate cerebral perfusion pressure. The management of

severe TBI also requires collaboration across multiple disciplines, including the involvement

of critical care nurses, neuro-intensivists, neuro-surgeons, respiratory therapists, and other

medical specialties. Although the management of this condition can be challenging, involving

many different disciplines can lead to omissions in care, and duplicated services; this can

create inefficiencies in care and potentially increase the risk of harm to the patient

(Haddadsm 2010). The provision of high-quality, evidence-based care can be effective in

reducing variations in practice and improving patient outcomes (Howell, 2014). Clinical

pathways provide a means by which to synchronise the best available evidence with clinical

practice in order to facilitate the delivery of high quality care (Rotter et al. 2010).

Clinical pathways are multidisciplinary tools that provide explicit, best practice guidance on

the management of patients with particular diagnoses, or for particular procedures. Current

evidence indicates that the provision of clinical pathway directed care can contribute to

significant improvements in health outcomes, with a Canadian study demonstrating

significant improvement in hospitalization days, morbidity and mortality rate in nursing

home residents with pneumonia (Loeb et al. 2006). However, the evidence of the

effectiveness of clinical pathway directed care for the management of severe TBI is lacking,

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 and in terms of effectiveness in Middle Eastern populations and for hospitalisation-related

outcomes, the evidence is absent. In light of this, there is a need to determine whether clinical
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pathways are effective in improving the clinical outcomes of patients with severe TBI. The

current study aims to address this knowledge gap by comparing the effectiveness of clinical

pathway directed care to usual care in improving hospitalisation-related outcomes in adults

with STBI.

METHODOLOGY
Research design: The study adopted a quasi-experimental design; specifically, a

prospective, non-randomised, open-label, controlled trial design. The study comprised three

distinct phases, including: (1) development of a clinical pathway for severe TBI; (2) pilot

testing of the clinical pathway and study protocol; and (3) examination of the effectiveness of

a severe TBI clinical pathway versus usual care.

Aims and hypotheses: The study investigated whether the implementation of a clinical

pathway for patients with severe traumatic brain injury improves hospitalisation-related

outcomes when compared with usual care. To address this aim, the following hypotheses

were tested:

Primary hypotheses

Patients with STBI receiving clinical pathway directed care will:

1. Exhibit significantly fewer complications related to hospitalisation (e.g. hyperthermia,

pressure ulceration, infection, procedural pain and hyperglycaemia) than those receiving

usual care

2. Demonstrate less than 20% of clinical variances related to the prevention of

hospitalisation-related complications (e.g. DVT prophylaxis, pressure ulcer prevention).

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 Secondary hypotheses

Patients with STBI receiving clinical pathway directed care will:

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1. Exhibit a significantly shorter ICU length of stay than those receiving usual care

2. Demonstrate significantly fewer re-admissions to the ICU than those receiving usual

care

3. Demonstrate a significantly higher level of satisfaction with the care process, care

structure and care outcome than those receiving usual care.

Sample and setting: The pilot and main study were conducted at the Trauma Intensive Care

Unit (ICU) of the Main Assiut University Hospital, the largest teaching hospital in Assiut

City, Egypt. Participant inclusion criteria included: aged 18-60 years (this age group was

selected because it represented an adult population that is likely to require a similar approach

to TBI management), and Glasgow Coma Scale(GCS) score between 3 and 8 (a GCS within

this range is indicative of severe traumatic brain injury).

The sample size for the current study was based on an expected difference in primary

outcomes (i.e. complications and the clinical variances) of 40% between the intervention and

control group; this was based on data derived from the phase II pilot study. A sample size of

60 adult patients (i.e. 30 patients in each study arm) was expected to have 80% power to

detect a statistically significant difference in the primary and secondary outcomes (i.e.

complications, clinical variances, duration of MV, ICU stay and readmission) with a beta

level of 0.8 and a two-tailed alpha level set at 0.05.

Methods: Phase I of the study (i.e. the development of the STBI clinical pathway) began

with a critical review of the relevant literature. A comprehensive search of MEDLINE,

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 ProQuest, ScienceDirect, CINAHL and Google Scholar were undertaken to identify articles

that reported the evidence-based assessment, diagnosis and management of patients with
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severe traumatic brain injury. The search was restricted to articles published in the last ten

years (2004 to 2014) to ensure recency of evidence for phases II and III of the study. The

relevant literature was reviewed, along with theoretical frameworks describing the structure

and design of clinical pathways, as well as other pertinent clinical pathways (e.g. cardiac

pathways, wound care pathways), to develop a preliminary clinical pathway for severe TBI.

Five experts in the field of critical care and anaesthesiology examined and confirmed the face

and content validity of the clinical pathway.

The clinical pathway was a 15-page, double-sided, A4, paper-based document, which

comprised two instruments: the traumatic brain injury assessment checklist (containing four

parts) and the patient progress variances checklist (containing three parts). The traumatic

brain injury assessment checklist, which was designed to assess patients in both study groups,

gathered the following information: socio-demographic and health history, Glasgow Coma

Scale, injury severity scale, and clinical data. The patient progress variances checklist was

designed only for patients in the intervention group and provided guidance on daily

actions/tasks that could be performed to address each clinical objective. The variance

checklist, also recorded variations in care, that is, care that deviated from the clinical

pathway.

Pilot testing of the clinical pathway (phase II) was carried out between September 2014 and

October 2014. Six, consecutively selected, critically ill patients with severe TBI (assigned to

the intervention group only) were recruited (i.e. 10% of the total sample size required for the

phase III study). The purpose of phase II was to determine the feasibility of the study

protocol, clinical pathway and data collection instruments. The pilot study was similar in

every way to the main study, including the study setting, participant selection criteria,

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 duration of intervention (i.e. 15 days), and outcome measures used. Necessary revisions to

the clinical pathway and study protocol were made prior to commencing phase III (e.g. the
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main tools were originally designed to assess/manage patients over a seven-day period, but it

was the opinion of the experts to assess/manage patients over a fifteen-day period; experts

also recommended adding several additional actions/tasks to the pathway and omitting one

other).

Phase III of the study commenced in October 2014 and was completed by April 2015. All

persons presenting to emergency who met the study selection criteria were invited to

participate. Consenting participants were consecutively assigned by the researcher to usual

care or clinical pathway directed care between October and December 2014, and January and

April 2015, respectively. Participants assigned to usual care received 15 days of routine

nursing, medical and ancillary care in the trauma ICU of the hospital. Participants assigned to

the clinical pathway group received 15 days of care directed by a multidisciplinary clinical

pathway for severe TBI (noting that even though data collection ceased at 15 days, patients

continued to receive pathway-directed care after the trial to ensure continued access to best

practice care). The pathway required nursing, medical and ancillary staff to observe and

manage the patient across three phases; the admission phase (i.e. the first 24 hours), the acute

care phase (i.e. days two to eight) and mobility and weaning phase (i.e. days nine to fifteen).

The pathway was reviewed by staff on each shift (i.e. three shifts a day), and any variances to

the pathway or complications were reported. The researcher also provided health education

for the family members of participants in the intervention group on the second day of patient

admission; the education included a description of the care to be provided to the patient each

day, and information about the injury, complications, prognosis and care after discharge.

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 Outcomes: The main outcomes of the study are defined and operationalised below:
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- Complications related to hospitalisation, or adverse events, are an unintended harm

attributed to medical management or lack thereof. Complications were monitored and

recorded daily throughout the patients’ hospitalization period using the patient progress

variance checklist; this was documented by the researcher.

- Clinical care variances refer to the delivery of different levels of care amongst patients

with comparable demographic characteristics, diagnoses, and prognoses, despite the

presence of established and clearly documented evidence of best practice. Clinical

variances were measured across the following areas: assessment, diagnostic studies,

medications, intravenous solution, diet, activity, nursing care, consultation, health teaching

and discharge planning. These variances were measured by the researcher at each shift over

the fifteen-day of study period, using the patient progress variance checklist.

- Length of stay in ICU refers to the period of time the patient was situated within the ICU

(i.e. from the time the patient was admitted to the ICU, until their discharge from the unit).

The length of stay in the ICU was measured by the researcher at the end of the 15-day

study period by counting the number of the days information was recorded in the TBI

assessment checklist.

- Re-admission to ICU is defined as a second admission to the ICU within the same

hospitalization episode, for a diagnosis or problem similar or identical to the initial ICU

admission. Re-admission to the ICU was monitored by the researcher and recorded at the

end of the 15-day study period using the TBI assessment checklist.

- Patient/family satisfaction refers to the patient's/family's perceptions of the quality of the

health care service. Patients (if oriented) and/or family members in each study group were

interviewed by the researcher using the patient/family satisfaction tool before the end of the

study (day fourteen). Each interview lasted between 15 and 20 minutes.

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 Statistical analysis: All data cleaning and analyses were completed using IBM SPSS
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(version 20.0) software. Categorical variables were described using numbers and percentages.

Chi-square (χ2) tests were used to measure associations between categorical variables.

Continuous variables were described using means and standard deviations, with comparisons

made between continuous variables using either t-tests or Mann Whitney U tests. Continuous

variables were also tested for normal distribution using the Kolmogorov-Smirnov test and Q-

Q Plots. Where differences in demographic characteristics between groups were reported at

baseline, ANCOVA was used to test the statistical significance of the relationship between

the independent and dependent variables after controlling for the effects of the covariate(s).

The level of statistical significance for all tests was set at p<0.05.

Ethics: Written approval to conduct the current study was attained from the Assiut University

Hospital administrative authority. The study was also conducted in accordance with the

Assiut University Hospital Ethics Committees policy and the Declaration of Helsinki.

RESULTS

Demographic characteristics of the sample

Table 1 presents the demographic characteristics of the patients assigned to the intervention

and control groups. Participants in both groups were predominantly male and educated.

Participants in the intervention group were on average 10.7 years younger than those in the

control group, with the difference in mean age between groups found to be statistically

significant (p=0.001). There were also between-group differences in the marital status of

participants, with more patients in the intervention group being single (53.3%), and a greater

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 proportion of patients in the control group being married (63.3%); however, the difference

between groups was not statistically significant.

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Clinical characteristics of the sample

The event most likely to lead to TBI in both groups was a motor car accident, which

represented 49.9% of cases in the intervention group and 56.3% of cases in the control group.

Other events leading to TBI were motor bicycle accident (20% in the intervention group and

10% in the control group), falling from a height (20% and 6.7%), assault from another (6.6%

and 20%), firearm injury (3.3% and 0.0%) and a fall to the ground (0.0% and 6.7%). In terms

of past medical history, most patients (86.7% in the intervention group and 83.3% in the

control group) had no co-morbidities. By contrast, most patients (93.3% in the intervention

group and 86.6% in the control group) had poly-trauma on admission. The mean differences

of total injury severity score in intervention group were 19.3 while in control group were

18.5. Differences between groups in past medical history, presence of poly-trauma, type of

event leading to TBI and Injury Severity Score were not statistically significant

Frequency of complications related to hospitalisation

The frequency of complications related to hospitalisation reduced in both study groups over

time (Figure 1). Differences between groups in the occurrence of fever, pressure ulcers,

procedural pain (i.e. did not require lidocaine) and hyperglycaemia were statistically

significant (p=0.004, p=0.062, p=0.002 and p=0.022, respectively), with relatively fewer

cases of these complications reported in the intervention group. After controlling for age, the

intervention still had a significant effect on procedural pain (F [1,57] = 9.027, p = 0.004), but

not fever (F [1,57] = 2.717, p = 0.105), pressure ulcers (F [1,57] = 1.284, p = 0.262)

or hyperglycaemia (F [1,57] = 1.276, p = 0.263).There were no statistically significant

differences between groups in the occurrence of infection with fungi, gram-negative bacilli or

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 gram-negative cocci, deep venous thrombosis, vascular injuries or multiple organ system

failure.
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Overall variance

Variances to the clinical pathway that relate to the prevention of hospitalisation-related

complications are reported in Table 2 (for the intervention group only). Variances occurred

most frequently in areas relating to nursing care (i.e. use of circulating air-cooling blankets

[100%], air matrices [16.7%] and graduated stockings [13.3%], and meeting the 4-day

tracheostomy target [3.3%]) and professional consultations (i.e. rehabilitation consultation

[100%] and social worker consultation [100%]). No variances to the clinical pathway were

reported for patient/family health teaching. The most common reasons for the variations to

the clinical pathway were non-availability of services/equipment and action not applicable or

indicated.

Invasive devices duration

Table 3 outlines the differences in the frequency and duration of use of invasive devices

between study groups. The frequency of use of invasive devices was not significantly

different between groups for any device. Most invasive devices were in-situ for a relatively

shorter period of time in the intervention group than the control group; however, the only

statistically significant difference between groups was in the duration of central venous

catheter use (p=0.028).

Length of ICU stay and re-admission to ICU

Length of stay in the intensive care unit (ICU) and number of re-admissions to the ICU are

illustrated in Figure 2. Differences between groups in mean length of ICU stay and mean

number of re-admissions to the ICU were statistically significant (p=0.007 & p=0.001,

respectively), with relatively smaller means reported in the intervention group. After

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 controlling for age, the intervention still had a significant effect on length of ICU stay

(F [1,55] = 7.341, p = 0.009), but not rate of re-admission to the ICU (F [1,57] = 0.213, p =
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0.646)."

Patient/family Satisfaction

In relation to the level of patient/family satisfaction with the care structure (Table 4), there

was a statistically significant difference between groups in areas relating to the hospital

environment (p=0.001), privacy (p=0.001), safety (p=0.004) and diet (p=0.001), with

relatively higher satisfaction scores reported in the intervention group across all four areas.

Patient/family satisfaction scores relating to care processes (i.e. respecting patient dignity,

maintaining social life, caring approach by nursing/medical/auxiliary teams and hospital

administration, and family education) and care outcomes (i.e. hospitalisation outcomes), are

presented in Table 5. There were no statistically significant differences between the

intervention and control groups in relation to the level of patient/family satisfaction with the

hospital administration processes. Differences between groups across all other process and

outcome areas were statistically significant (p=0.001), with relatively higher satisfaction

scores reported in the intervention group.

Table 6 illustrates the overall level of patient/family satisfaction with care (i.e. Care structure,

process and outcome) in the control and intervention groups. Chi-square analysis revealed a

statistically significant association between overall patient/family satisfaction and study

group (X2= 60.0, p< 0.001), with higher levels of satisfaction reported in the intervention

group.

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 DISCUSSION
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The utilisation of multidisciplinary clinical pathways for the management of various clinical

presentations has been associated with improvements in patient outcomes, adverse events and

health care costs (Santamaria et al. 2003). Notwithstanding, there has been very little research

to date examining the effectiveness of clinical pathways for patients with severe traumatic

brain injury (Harris et al. 2012). This is the first known study to examine the effectiveness of

clinical pathway directed care on hospitalisation-related outcomes in adults with STBI. The

study findings indicate that clinical pathways may offer patients and institutions some benefit

in terms of hospitalisation-related complications, length of ICU stay, ICU readmission rates,

and satisfaction with care, relative to usual care. The extent to which these findings might be

applicable to other patients with STBI requires a closer look at the study sample.

The sample

The study sample overall was predominantly young, male, married and educated. The higher

ratio of married and educated participants within this study could not be explained. The

higher ratio of males to females, and the young age of participants, is understandable

however, as this is typical of the general TBI population. This can be explained by the fact

that males are more prone to trauma during driving (the most common cause of head injury)

than females (Frieden et al. 2015); further, according to data from the Centers for Disease

Control and Prevention (Sahler & Greenwald 2012), head injury is most likely to occur in

males aged between 14 and 24 years.

The study sample was also reasonably homogenous in terms of clinical presentation, with

most participants presenting with a non-penetrating head injury secondary to a motorcar

accident, as well as poly-trauma, a GCS between 6 and 8, and the absence of any co-

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 morbidities. These characteristics are similar to the general head injury population in Egypt.

For instance, data from Farghaly et al (2007) indicate that 60% of patients admitted to Assiut
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hospital (Egypt) with head injury had sustained their injury from a road traffic accident, with

the highest incidence occurring in the age group of 20 to 29 years. Similarly, evidence from

the trauma audit and research network (TARN) showed that around 16% of trauma registry

patients (26,514 patients) between 1989–2007 had signs of poly-trauma; that is, significant

injuries to more than one body region (Pape et al. 2010). Unfortunately, there are insufficient

published data on typical GCS scores and the presence of pre-injury co-morbidities in

patients with severe traumatic brain injury. Notwithstanding, the sample of the current study

appeared to be generally representative of the head injury population in Egypt.

The only statistically significant difference observed between groups at baseline was the age

of participants. Participants in the intervention group were on average 10.7 years younger

than those in the control group. Whilst there is no obvious explanation for the difference in

age between groups, the difference is of clinical importance as older age has been shown to

have a negative impact on patient outcomes post-TBI (e.g. complications and mortality) (Røe

et al. 2013). The differences in the age of participants between groups could provide a

plausible alternate explanation for the improvements observed among participants in the

clinical pathway group for some, but not all, study outcomes, as discussed below.

Complications related to hospitalisation

The aim of this study was to determine whether the implementation of a clinical pathway

could improve the complications of hospitalisation among adults with STBI. The outcomes of

primary interest were hyperthermia, pressure ulceration, presence of procedural pain,

hyperglycaemia, infection, clinical variances related to the prevention of hospitalisation-

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 related complications, and ICU length of stay and re-admission rate. A discussion of the

findings relating to each of these outcomes now follows.

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Hyperthermia

There is a clear rationale for why body temperature must be controlled and pyrexia

aggressively managed in patients with severe TBI, with evidence suggesting that moderate

systemic hypothermia or normothermia can reduce cerebral metabolism, lower intracranial

pressure and raise cerebral perfusion pressure (Haddad & Arabi 2012). The current study

found statistically significantly fewer cases of fever in the intervention group than the control

group. This suggests that the implementation of the clinical pathway may have improved the

management of hyperthermia, possibly because the strategies outlined in the clinical pathway

were informed by the best available evidence. The use of antipyretic medication, cooling

blankets, ice packs, and cooled intravascular fluids as recommended in the pathway parallel

national and regional trends in fever and hyperthermia management as well as neuroscience

nurse decision-making, both nationally and regionally (Young & Saxena 2014).

Of course, many factors can impact body temperature, including environmental temperature.

For instance, during periods of persistent high ambient temperature, hyperthermia can arise in

critically ill infected patients and to a minor extent, in non-infected patients. In the current

study, the control group was conducted between summer and autumn, and the intervention

group conducted between winter and spring, thus exposing participants in the control group

to higher ambient temperature and potentially to an increased risk of elevated body

temperature. Whilst such an explanation is plausible, given the presence of air-conditioning

in the intensive care unit, it is unlikely that the timing of the study groups and subsequent

seasonal variations would have contributed much to the differences in this outcome between

study groups.

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 Pressure ulcers

Pressure ulcers are serious complications that commonly develop in individuals with severe
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traumatic brain injury (Dhandapani et al. 2014). Preventing pressure ulceration in

hospitalised patients is a clinical priority as the development of these wounds is associated

with a long list of negative patient and economic outcomes, including delayed enteral

feeding, fall in haemoglobin level, increased hospital length of stay (LOS), greater mortality

and health-care expenditure and decreased patient and family satisfaction with care

(Dickinson & Tschannen 2012). Findings from the current study revealed statistically

significant differences between groups in the occurrence of pressure ulcers, with no cases of

pressure ulceration reported in the intervention group compared to five reported cases in the

control group. It is probable that the application of the evidence-based pressure ulcer

prevention methods outlined in the STBI clinical pathway (e.g. changing patient position

every two hours, maintaining good body alignment, use of air mattresses, applying range of

motion exercises, massaging the lower limbs and back and sitting the patient out of bed)

contributed to these differences between groups, as the control group only received routine

hospital care (e.g. changing patient position every two hours and applying range of motion

exercises). It is also probable that the maintenance of adequate nutrition in the clinical

pathway group contributed to differences in the occurrence of pressure ulceration between

groups. This is because nutrition plays a central role in supporting tissue viability and the

preservation of skin integrity, both of which are critical to the prevention of pressure

ulceration and healing of existing ulcers (Kennerly et al. 2015).

Despite the aforementioned findings, the higher mean age of participants in the control group

could have played a part in the greater occurrence of pressure ulcers in this group, with

empirical evidence strongly supporting the relationship between advancing age and the

development of pressure ulcers in critical care patients. The results of ANVOVA certainly

This article is protected by copyright. All rights reserved.

 suggest that the effect of the intervention on pressure ulcer occurrence was clearly modified

by age. Notwithstanding, the degree to which age contributed to the difference in pressure
Accepted Article
ulcer occurrence between groups is questionable as the control group was still relatively

young (i.e. 39 years), with studies indicating that pressure ulcers typically develop in much

older patients (i.e. 73 years) (Cox, 2011).

Use of lidocaine and presence of pain

Critically ill adult patients often experience considerable pain during hospitalisation, with

more than 30% of ICU patients reporting substantial pain at rest, and over 50% experiencing

marked pain during usual care, including endotracheal suctioning, repositioning, and wound

management (Puntillo et al. 2014). Lidocaineis widely used to reduce procedural pain, such

as endotracheal or nasogastric tube insertion. Evidence from a prospective study of nineteen

patients in a medical ICU in Taipei, Taiwan (Lee et al. 2012) lends some support to this

practice, concluding that lidocaine spray is effective in reducing pain caused by endotracheal

tube insertion.

The findings of the current study concur with the results of the aforementioned study (Lee et

al. 2012), revealing significantly fewer cases of procedural pain in the intervention group

than the control group. This may be because the clinical pathway encouraged nursing and

medical staff to deliver best practice care around minimising the occurrence of procedural

pain. However, given that the intervention and control group were administered at different

points in time, other factors influencing the occurrence of pain cannot be dismissed, such as

the variability in techniques provided by different nursing and medical personnel. It was

certainly the case in the current study that the nursing and medical staff present during the

control phase and intervention phase were different; this is mainly due to the level of staff

turnover (including medical staff rotations) observed over the seven-month study period. A

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 retrospective study of critically ill intubated patients has shown that such variations in

staffing can lead to differences in the level of pain experienced during procedures (Gélinas et
Accepted Article
al. 2004).

Hyperglycaemia

The acute sympathoadrenomedullary response following trauma is characterised by elevated

catecholamine levels, which predisposes patients with severe traumatic brain injury to

hyperglycaemia. Hyperglycaemia is also positively correlated with infection, the need for

intensive care, hospital length of stay, and mortality (Salim et al. 2009). As such, the

effective management of hyperglycaemia should not be overlooked in the overall

management of severe TBI in the ICU.

In the current study, participants receiving care guided by the TBI clinical pathway

demonstrated significantly fewer cases of hyperglycaemia than participants receiving usual

care. This may be because the strategies outlined in the clinical pathway were informed by

the best available evidence (e.g. administration of intensive insulin therapy for serum glucose

levels exceeding than 120 mg/dl) (Salim et al.2009). This is supported by findings from a

prospective observational study of 100 patients hospitalized in an Eastern European medical

intensive care unit. The study found protocol-directed intensive monitoring and insulin

therapy to be effective in the treatment of hyperglycaemia in critically ill patients (Godinjak

et al. 2015). It is also possible that the improvement in blood glucose levels in the

intervention group may have been mediated by age (as shown by ANCOVA), with evidence

from cross-sectional studies indicating that plasma glucose levels rise with increasing age in

non-diabetic adults (Ko et al. 2006).

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 Infection

Patients with severe traumatic brain injury are particularly prone to developing infections and
Accepted Article
sepsis because clinical symptoms and conventional markers are not always reliable indicators

of infection in this patient group. Adding to this, patients with Glasgow Coma Scale scores

less than nine (as is the case in severe TBI) have relatively higher rates of upper airway

microbial colonisation (Feasal et al. 2015), possible attributed to the aspiration of high

inoculum oropharyngeal secretions immediately following brain injury, during resuscitation,

and as a result of intubation. The presence of long-term invasive devices such as urinary

catheters or intravenous cannulae compounds this risk (McClelland & Moxon, 2014)

The findings of the current study revealed no significant differences between study groups in

terms of the occurrence of infection with fungi, gram-negative bacilli or gram-negative cocci;

however, there were fifty-five percent fewer cases of infection reported in the clinical

pathway group. The lower infection rate in the intervention group may be related to the

relatively fewer risk factors for infection observed in this group, such as reduced number of

days with invasive devices in-situ, decreased incidence of pressure ulceration and greater

adherence infection control practices. This is supported by findings from a meta-analysis of

twenty-two studies examining the effectiveness of clinical pathway directed care for hip and

knee joint replacement. The analysis revealed significantly fewer reports of postoperative

complications, including superficial and deep infections, among patients receiving clinical

pathway care when compared with standard care (Barbieri et al. 2009).

Overall variances

Reports from Australia and overseas suggest that deviations in clinical practice are not

atypical even where approved clinical practice guidelines are available. Unnecessary

variations that are unable to be attributed to disease severity or patient factors are common,

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 and clinical practice is often idiosyncratic and unscientific (Kennedy et al 2010). Clinical

pathways aim to reduce such inconsistencies in clinical practice and to facilitate the delivery
Accepted Article
of evidence-based practice.

The findings of the current study suggest that the clinical pathway for severe traumatic brain

injury may have fostered the uptake of best practice, with few variances to the evidence-

based clinical pathway reported. It is also possible that because of the nature of the study

design, and that variances were not (understandably) measured in the control group, that

nursing, medical and ancillary staff may have already been delivering best practice care. The

limitation of the current study highlights the need for future clinical pathway studies to more

closely monitor clinical practice in control groups to determine the extent to which clinical

pathways may impact the delivery of best practice care.

Variances occurred in the intervention group most frequently in areas relating to nursing care.

The most common reasons for the variations to the clinical pathway were non-availability of

services/equipment and actions not applicable or indicated. Most studies agree that

insufficient funds and decreased availability of equipment and resources can affect the

delivery of services to patients in hospitals, adversely affecting perceptions of health service

quality, patient satisfaction and patient loyalty (Wanjau et al. 2012). These findings suggest

that if sufficient resources and services were available to nurses, adherence to the clinical

pathway, and thus best practice, may have been greater. Notwithstanding, there are multiple

and diverse reasons for variations in clinical practice (Kennedy et al 2010), thus the provision

of necessary services/equipment may only partially address variations to a clinical pathway.

Understanding how other factors contribute to such variations in clinical pathways should be

the focus of future research.

This article is protected by copyright. All rights reserved.

 Invasive devices duration

Invasive medical devices play an essential role in the monitoring and management of
Accepted Article
critically ill patients. However, the presence of an indwelling invasive device is a recognised

risk factor for healthcare-associated infection (HAIs), such as ventilator-associated

pneumonia, central venous catheter related bloodstream infections and catheter-associated

urinary tract infections (Loveday et al. 2014). Hence, the early removal of invasive medical

devices is an important strategy in reducing infection risk in hospitalised patients (Evik et al.

2013).

The current study found invasive devices to be in-situ for a relatively shorter period of time in

the intervention group than the control group. This suggests that there was greater adherence

to best practice in the intervention group, possibly translating to a lower risk of harm from

invasive device-associated hospital infection among participants in this group. The impact of

clinical pathways on infection rates also has been demonstrated by Walker et al. (2012), who

showed the introduction of a bronchiolitis clinical care pathway to be effective in reducing

the proportion of infants with infection as well as the use of prescribed salbutamol. In a

systematic review and meta-analysis of the effects of clinical pathways on patient outcomes,

hospital costs and length of stay, Rotter et al, (2008) revealed a significant reduction in the

duration of invasive devices. Both of these studies corroborate the findings of the current

study, thus supporting the value of clinical pathways in reducing healthcare associated

infection.

Length of stay and re-admission

Many clinical studies on traumatic brain injury have used length of stay (LOS) as a health

care performance indicator, with many using pre-defined LOS as an “economic” outcome

and a suitable surrogate for hospital expenditure (Lazaridis et al. 2015). The current study

This article is protected by copyright. All rights reserved.

 indicates that clinical pathway directed care may influence the duration of hospitalization, but

possibly not ICU re-admission rate, with patients in the pathway group demonstrating
Accepted Article
significantly shorter lengths of stay in the ICU than patients in the control group. These

findings may be attributed to a number of factors, such as the shorter duration of mechanical

ventilation, meeting the 4-day tracheostomy target (Hosokawa et al. 2015), earlier

mobilization, earlier return of oral intake, and the education of hospital healthcare providers

in the intervention group. The findings of this study corroborate the results of other studies,

which have shown clinical pathways to be effective in reducing the number of hospitalisation

days, health care costs and mortality rates in persons with pneumonia, lower respiratory tract

infection and heart failure (Loeb et al. 2006). These findings highlight the potential economic

benefit of implementing clinical pathways in STBI; an important focus of further research in

this area would be to examine the cost-benefit of implementing clinical pathways in STBI.

Patients/Family Satisfaction

While patient satisfaction is regarded as one of the most desired outcomes of care, and is a

key domain of quality care, the assessment of patient satisfaction in the critical care

environment is somewhat complicated. Patients in the critical care setting are typically not

able to make decisions about their care because of the level of consciousness or severity of

illness (Stricker et al. 2007). Likewise, patients in this setting are often too ill to ascertain the

level of satisfaction with care or may not even recall the critical care experience;

consequently, patient satisfaction surveys may not be an adequate measure of satisfaction in

the critical care environment. Instead, family members are frequently the ones to establish a

patient’s satisfaction with care, as well as the patient’s overall critical care experience. In

other words, satisfaction may be measured by the family member's perception of care

delivered rather than the actual care received (Roberti & Fitzpatrick 2010).

This article is protected by copyright. All rights reserved.

 In the current study, there was a statistically significant difference between groups in

perception of care structure, with relatively higher satisfaction levels reported in the clinical
Accepted Article
pathway group across areas relating to the hospital environment, privacy, safety and diet.

Differences between groups across care processes and care outcomes were statistically

significant, with relatively higher satisfaction scores reported in the intervention group.

However, there was no statistically significant difference found between the intervention and

control groups in regards to satisfaction with hospital administration.

The significant improvements in patient/family satisfaction across multiple aspects of care

correlates with the findings of other clinical pathway research (Neves et al 2009). In an

earlier review of 200 studies evaluating the effectiveness of clinical pathways (Van Herck et

al. 2004), 66% of the included studies reported a positive effect on clinical pathway

outcomes, with 62% reporting a positive effect on patient satisfaction. Similarly, Hassan et al.

(2014) had shown that the implementation of a diabetic ketoacidosis (DKA) clinical pathway

had empowered clinicians to deliver evidence-base practice, which in turn, resulted in the

provision of better patient care. These findings suggest that clinical pathways may foster a

positive patient experience not only by improving the safety and quality of patient care, but

by enhancing patient, family and clinician education and communication.

Limitations

There are several limitations to this study that may affect the interpretation and

generalizability of the findings. The most notable limitation of the current study was the

study design. The collection of data for each of the two groups occurred at different time

points, which may have increased the risk of chronology bias (Paradis, 2008). Further,

without participant/family and clinician blinding, we cannot exclude the possibility that

expectation bias impacted the results. It is also possible that the absence of randomization

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 may have increased the risk of selection bias. However, given that the two study groups were

similar across all clinical variables and demographic variables (except for age), the likelihood
Accepted Article
of selection bias is very small. Nevertheless, patients in the intervention group were on

average ten years younger than those in the control group; this difference is of clinical

importance as older age has been shown to have a negative impact on patient outcomes post-

TBI (Dhandapani et al. 2012).

CONCLUSIONS AND RECOMMENDATIONS

Severe traumatic brain injury can lead to considerable morbidity and disability, even death, if

not promptly diagnosed and treated. The findings of the present study suggest that the

implementation of clinical pathway directed care for adults with STBI may be useful in

improving procedural pain, the patient experience, and potentially, decreasing health care

expenditure (via reductions in ICU length of stay). Further research is needed to determine

whether these findings can be reproduced in persons of different age groups (i.e. older adults

and children), in different settings, and over longer periods of time. Such research should also

consider the economic impact of using clinical pathways for STBI.

ACKNOWLEDGMENTS

We would like to thank the Assiut University Hospital Trauma ICU, Egypt, for their support

with participate recruitment and data collection. We would also like to thank the study

participants for their involvement in the study.

FUNDING
The study was not supported by funding from any agency.

This article is protected by copyright. All rights reserved.

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 Tables and Figures

Table 1: Demographic characteristics of participants by study group

Accepted Article
Intervention Control P value
Age (year), mean + SD 29.0+10.2 39.7+13.7 0.001
Gender, n (%)
Male 28 (93.3) 26 (86.7)
0.389
Female 2 (6.7) 4(13.3)
Marital status, n (%)
Single 16 (53.3) 10 (33.3)
Married 14 (46.7) 19 (63.3) 0.208
Divorce 0(0.0) 1 (3.3)
Level of education, n (%)
Educated 28 (93.3) 26 (86.7)
0.389
Illiterate 2(6.7) 4(13.3)

27 **
24
21
18
15 * **
Number of patients

12
9 Intervention
*
6
3 0 Control
0

Complications related hospitalization

**significance at p< 0.005, * significance at p < 0.05

Figure 1: Frequency of complications related to hospitalisation by study group

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 Table 2: Occurrence of variances to the clinical pathway in the intervention group
Accepted Article
Intervention
Variance Reasons for variance
n (%)
Related to nursing care
Did not use of Cervical collar Not applicable 30 (100.0)
Did not use circulating air cooling Not available 30 (100.0)
blanket
Did not use air matrices Not available 5 (16.7)
Did not remove endotracheal tube Not required 1(3.3)
by day 4
Did not use graduated stocking Not available 4(13.3)
Related to activity
Did not move Patient on chair Condition of the patients not 5(16.7)
allowed
Related to medication
Did not use low molecular weight Not required 3 (10.0)
heparin
Did not give Midazolam Not required 6 (20)
Did not administer of vasopressor as Not required 5(16.7)
ordered
Related to diet / nutrition
Did not start oral feeding Condition of the patient not 4 (13.3)
allowed
Related to diagnostic studies
Did not monitor ECG Not required 4 (13.3)
Related to IV fluids
Did not use Blood product Not required 6 (20)
Related to consultation
Did not consult rehabilitation Not available 30 (100.0)
consultant
Did not consult social worker Not available 30 (100.0)
Related to health teaching and discharge planning
Did not deliver health teaching No variance 0.0(0.0)
Did not complete discharge planning Patients still in the ICU 4 (13.3)

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 Table 3: Frequency and duration of use of invasive devices by study group
Invasive devices Number of patient's Duration insitu (days)
Intervention, Control, Intervention, Control, Mean difference
Accepted Article
P value P value
n (%) n (%) mean + SD mean + SD (95% CI)
Endotracheal tube -0.8
30 (100) 29 (96.7) 0.313 3.9+1.4 4.7+2.4 0.096
(-1.87,0.16)
Tracheostomy -0.6
9 (30) 7 (23.3) 0.770 4.5+1.2 5.1+1.1 0.295
(-1.92,0.63)
Central venous -1.6
30 (100) 29 (96.7) 0.313 12.1+3 13.7+2.5 0.028
catheter (-3.1,-0.18
Chest tube -2.2
17(56.7) 22 (73.3) 0.176 5.2+5 7.4+4.7 0.093
(-4.64,0.37)
Peripheral catheter 0.2
30 (100) 29 (96.7) 0.313 14.1+1.2 13.9+2.9 0.648
(-0.90,1.43)
Urinary catheter -0.6
30 (100) 29 (96.7) 0.313 14.1+1.5 14.7+1.2 0.104
(-1.3,0.13)
Nasogastric tube -5.3
30 (100) 29 (96.7) 0.313 12.1+2.9 17.4+20.2 0.091
(-12.78,2.15)

18
16 **
14
12
10
Mean

**
8
Intervention
6
Control
4
2
0
LOS in ICU Readmission to ICU

LOS= length of stay, ICU= Intensive care unit, ** significance at p< 0.005

Figure 2: Length of ICU stay and readmission to ICU, by study group

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 Table 4: Patient / family satisfaction with the care structure, by study group

Mean
Satisfaction with Intervention Control difference T value
Accepted Article
Cohen’s d P value
care structure (95% CI)
Mean+ SD Mean+ SD
a 1.1
Environment 20 + 1.1 18.9 + 0.3 1.36 5.02 0.001
(0.69,1.52)
b 1.5
Safety 19.1 + 1.6 17.6 + 2.1 0.80 3.05 0.004
(0.5,2.4)
c 2.0
Diet 9.9 + 0.5 7.9 + 1.0 2.53 9.71 0.001
(1.59,2.4)
d 0.7
Privacy 6.9 + 0.9 6.2 + 0.4 1.01 3.70 0.001
(0.31,1.03)
a
Environment satisfaction: 7 questions; scoring: rarely (1), sometimes (2) & always (3); maximum score = 21
b
Safety satisfaction: 8 questions; scoring: rarely (1), sometimes (2) & always (3); maximum score = 24
c
Diet satisfaction: 4 questions; scoring: rarely (1), sometimes (2) & always (3); maximum score = 12
d
Privacy satisfaction: 4 questions; scoring: rarely (1), sometimes (2) & always (3); maximum score = 12

Table 5: Patient / family satisfaction with care process and outcome, by study group

Mean
Satisfaction with care Intervention Control Cohen’s
difference T value P value
process & outcome d
Mean+ SD Mean+ SD (95% CI)
a 6.2
Hospitalisation outcome 19.1+ 0.9 12.9+ 1.0 6.52 21.82 0.001
(6.16,6.89)
b 5.5
Respect dignity 18.3 + 0.9 12.8 + 1.0 5.78 21.80 0.001
(4.9,5.9)
c 3.7
Caring by auxiliary team 17.0 + 1.5 13.3 + 1.6 2.39 14.30 0.001
(3.12,4.01)
d -0.6
Hospital administration 14.1 + 1.5 14.7 + 1.2 0.44 14.33 0.104
(-1.9,0.63)
e 4.5
Education 9.6 + 1.4 5.1 + 0.3 4.45 6.87 0.001
(4.1,5.04)
f 2.6
Caring by nursing team 8.5 + 0.7 5.9 + 1.1 2.82 19.41 0.001
(1.58,2.42)
g 1.5
Caring by medical team 8.4 + 0.7 6.9 + 1.0 1.74 16.07 0.001
(0.91,1.88)
h 1.4
Maintain social life 7.5 + 1.3 6.1 + 0.3 1.48 5.76 0.001
(0.92,1.88)
a
Hospitalization outcome: 7 questions; scoring: rarely (1), sometimes (2) & always (3); maximum score =21.
b
Respect dignity: 7 questions; scoring: rarely (1), sometimes (2) & always (3); maximum score =21.
c
Caring by auxiliary team: 7 questions; scoring: weak (1), good (2) &excellent (3); maximum score =21.
d
Hospital administration: 3 questions; scoring: weak (1), good (2) &excellent (3); maximum score =9.
e
Education: 5 questions; scoring: rarely (1), sometimes (2) & always (3); maximum score =15.
f
Caring by nursing team: 3 questions; scoring: weak (1), good (2) &excellent (3); maximum score =9.
g
Caring by medical team: 3 questions; scoring: weak (1), good (2) &excellent (3); maximum score =9.
h
Maintain social life: 5 questions; scoring: rarely (1), sometimes (2) & always (3); maximum score =15.

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 Table 6: Overall level of patient/family satisfaction with care, by study group

Intervention Control Chi-square

Overall satisfaction level P value
(X2)
Accepted Article
N (%) N (%)
90-100% 0 (0.0) 0 (0.0)
80-89% 16 (53.3) 0 (0.0)
70-79% 14 (46.7) 0 (0.0) 60.0 0.001
60-69% 0 (0.0) 13 (43.3)
<60% 0 (0.0) 17 (56.7)
Total 30 (100.0) 30 (100.0)

This article is protected by copyright. All rights reserved.