Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05721664 |
| Other study ID # |
EBNPTP-NC-MVP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2022 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
the overall aim of this study is to examine the effect of adapted Evidence-based nursing
practices training program on the competency level of nurses caring for Mechanically
ventilated patients in selected ICU in Egypt.
Significant of the study:
The current study is expected to improve the nurses' practices regarding caring for
mechanically ventilated patients in terms of optimal quality of care by keeping them up to
date with the latest (EBP). Also, it is likely to enhance nurses' confidence and work
satisfaction. Accordingly, all mentioned expected outputs will significantly impact either
patients or the Healthcare Delivery System (HDS) in Egypt. The implementation of the study
will be expected to positively impact minimizing mortality, morbidity, length of stay,
incidence of readmission, and costs. Accordingly, all mentioned expected outputs will
significantly impact either patients or the Healthcare Delivery System (HDS) in Egypt. Also
increases the satisfaction of patients and their families. Also, the current study is
expected to encourage health care providers in Egypt to increase the engagement of EBP as a
concept in patient care since EBP is rarely adopted in health care facilities especially in
Egypt [21-23]. in addition to recognizing the factors that may affect the implementation of
EBP in such Egyptian hospitals.
Hypothesis: H1: Nurses who are given an evidence-based nursing practices training program
(μ1) demonstrate a sustainable higher change in their level of competency than those who take
the current traditional in-service education (μ2) in respect of caring for mechanically
ventilated patients. (H1: μ1 > μ2).
Research Design:
A prospective, true experimental, and comparative research design will be used in the current
study. The type of true experiment that will be conducted is (pretest-posttest control). The
study will compare the current traditional in-service training with developed (EBNTP)
regarding the care of mechanically ventilated patients. True-experiment is research design
where the researcher initiates an experimental treatment, randomly assigns test units and
treatments to the experimental group, and use of control group [27].
Sample and Setting
The research will take place in an adult intensive care unit (ICUs) of the National
Hepatology and tropical medicine research institute (NHTMRI), Cairo, Egypt. In this study,
the sample size is expected to be 80 critical care nurses working in selected (ICUs)
estimated by (G Power analysis). Two groups will be selected randomly from the overall sample
size (study and control). All nurses should have met the following requirements to be
included:
- Willing to take part in this research.
- Hold the existing position for at least three months.
- Two years or more of critical care experience.
- Nurses who intend to leave their jobs four months from now will not be eligible.
Description:
Background:
Evidence-based practices (EBP) is a universal key approach for delivering standardized care
using the latest evidence to enhance healthcare quality and patient outcomes. EBP is a
problem-solving method to make a clinical decision within healthcare setting. Nurses play a
significant role in optimizing health service productivity. Further, they directly interact
with patients, especially in Intensive Care Units (ICU). Hence, healthcare organizations
should always work to make it simple for nurses on the frontlines to use the best evidence in
their everyday practices.
EBP in healthcare is not conceptually new. From a nursing perspective, Florence Nightingale
pioneered the concept of using research evidence to dictate care. The concept of EBP changed
as the nursing profession evolved, as with any other applied science. As early as 1972,
British medical researcher Archibald L. Cochrane criticized the medical discipline for
providing management that lacked proof by evidence. Cochrane Center, which ultimately
resulted in the founding of the Cochrane Collaboration in 1993. Cochrane continues to offer
systematic evaluations of randomized controlled trials of medical management to assess the
efficacy of provided care. The first detailed description of EBP and nursing in primary care
was published in 1996 . EBP in nursing has continue tremendous growth in the past few
decades.
ICU is the department that cares for critically ill patients with severe or life-threatening
illnesses, requiring constant care, close supervision, and high-alert caregivers. For
critically ill patients, mechanical ventilation (MV) is the most often employed therapeutic
treatment modality. MV is a machine that helps a patient breathe better when they cannot
breathe effectively. Mechanically ventilated patients are suspected of developing several
complications that negatively affect patient outcomes, such as increased patient costs,
length of stay, morbidity, and mortality rate.
While, EBP provides opportunities for nursing practices to be more individualized and
effective, one of the main obstacles in the clinical context worldwide is turning the
evidence into practice. Several of these obstacles were investigated such as lack of
administrative support, deficiency of interest, negative beliefs, attitudes and values, heavy
patient workloads, lack of resources, or inadequate staffing. By 2020, according to the
Institute of Medicine (2009), 90% of clinical decisions should be supported by evidence.
Since, EBP has been acknowledged as one of the fundamental skills that clinical nurses should
possess. Nurses alleged that there was a worldwide issue with having insufficient EBP
knowledge and skills for using EBP in practice. Nurses in Egypt has no exception, several
studies recommended extensive training of the nurses due to inadequate nurses' practices
regarding caring for patients with MV . Since, healthcare is rapidly evolving and there are
no shortcuts of practices, peak performance requires a lifelong passion of learning to
guarantee that the patients receive the best care in term of EBP as a priority globally.
Hence, the overall aim of this study is to examine the effect of adapted Evidence-based
nursing practices training program on the competency level of nurses caring for Mechanically
ventilated patients in selected ICU in Egypt.
Significant of the study:
The current study is expected to improve the nurses' practices regarding caring for
mechanically ventilated patients in terms of optimal quality of care by keeping them up to
date with the latest (EBP). Also, it is likely to enhance nurses' confidence and work
satisfaction. Accordingly, all mentioned expected outputs will significantly impact either
patients or the Healthcare Delivery System (HDS) in Egypt. The implementation of the study
will be expected to positively impact minimizing mortality, morbidity, length of stay,
incidence of readmission, and costs. Accordingly, all mentioned expected outputs will
significantly impact either patients or the Healthcare Delivery System (HDS) in Egypt. Also
increases the satisfaction of patients and their families. Also, the current study is
expected to encourage health care providers in Egypt to increase the engagement of EBP as a
concept in patient care since EBP is rarely adopted in health care facilities especially in
Egypt. in addition to recognizing the factors that may affect the implementation of EBP in
such Egyptian hospitals.
Hypothesis: H1: Nurses who are given an evidence-based nursing practices training program
(μ1) demonstrate a sustainable higher change in their level of competency than those who take
the current traditional in-service education (μ2) in respect of caring for mechanically
ventilated patients. (H1: μ1 > μ2).
Conceptual Framework:
The revised Johns Hopkins Evidence-Based Practice (JHEBP) Model for Nurses (2020) is designed
as a systematic and efficient approach to EBP in nursing that helps solve problems. Since a
conceptual framework illustrates the underlying structure and how researchers think their
study will operate, (JHEBP) model encompasses three essential components: Inquiry, Practice,
and Learning
Inquiry:
Inquiry is a basis for healthcare practice and incorporates a deliberate effort to question,
examine, and gather information about faced problem through clinical observation, assessment,
and composed experience within the clinical setting. The stated inquiry of the current study
is indicated by the researchers' observation, experience, and previous research. Moreover, a
pre-assessment of the nurses' level of competency may confirm the study inquiry.
Practice Practice demonstrates how nurses apply their knowledge to their work. It consists of
three items' process (Practice Question, Evidence, and Translation), it is the who, when,
where, what, why, and how that demonstrates the range of clinical activities that shape the
provided care. In order to JHEBP PET process, the researcher formulated the following PET
process
Learning:
learning defined by Braungart et al. (2014) as "a reasonably permanent change in skill,
and/or behavior as a result of experience". Transformational learning, also known as
behavioral changes, the basic objective of learning is to keep nurses' behavior from
changing. Staff must believe that changing practice will enhance the standard of care and
have a positive impact on patients' lives for EBP to be properly embraced and integrated into
the organization.
Research Design:
A prospective, true experimental, and comparative research design will be used in the current
study. The type of true experiment that will be conducted is (pretest-posttest control). The
study will compare the current traditional in-service training with developed (EBNTP)
regarding the care of mechanically ventilated patients. True-experiment is research design
where the researcher initiates an experimental treatment, randomly assigns test units and
treatments to the experimental group and uses of control group.
Sample and Setting
The research will take place in an adult intensive care unit (ICUs) of the National
Hepatology and tropical medicine research institute (NHTMRI), Cairo, Egypt. In this study,
the sample size is expected to be 80 critical care nurses working in selected (ICUs)
estimated by (G Power analysis). Two groups will be selected randomly from the overall sample
size (study and control). All nurses should have met the following requirements to be
included:
- Willing to take part in this research.
- Hold the existing position for at least three months.
- Two years or more of critical care experience.
- Nurses who intend to leave their jobs four months from now will not be eligible.
Study variables and measured outcomes:
Evidence-Based Nursing Training Program (EBNTP) regards caring for mechanically ventilated
patients (independent variable). It's an integrated training clinical course designed by the
researchers in terms of the concept of EBP. It consists of eight domains: Minimize ventilator
exposure, provide oral hygiene care; management of subglottic secretion; ensure adequate
staffing, Bronchial hygiene maneuvers, change ventilator circuits; give the prescribed
medications recommended in the VAP bundle; and promote extubation and MV liberation. Nurses'
level of competency is the dependent variable and measured outcome of the current experiment
that will be assessed by a structured observational (EBNCAC).
. Tools of Data Collection: For the purpose of the study, only one adapted data collection
tool will be used. "Evidence-Based Nursing Competency Assessment Checklist (EBNCAC) concerned
with caring of MV patients" is a structured observational checklist that was adapted and
compiled from many resources, including the Cochrane Library, AACN, and American Association
for Respiratory Care (AARC). Critical nursing and medical experts reviewed the tool for
content validity. Additionally, the program was adjusted to take advantage of the setting
amenities.
The charge nurses in the chosen ICU will serve as the assessors, who will observe and assess
the nurses' performance while caring the MV patients. Background information on the
participants will also be gathered, including participant code number, sex, years of ICU
experience, staff category, and educational level.
The eight domains encompassed in the training program were covered in the tool and
transformed into specific nursing actions. It consists of 74 points. Nursed response to each
item will be graded on a scale of 2 to 0. An item that is done correctly and satisfactorily
by the nurse will receive a score of 2; handled unsatisfactory item will get 1, Items that
are not performed will receive a zero score. The perceived level of skill will be classified
into three categories based on the total score of 148: High (> 120 / >80%), Moderate (74-120
/ 50-80%), and Low (74 / 50%).
Procedure:
The study will be carried out in three stages: planning and design, empirical, and evaluation
& follow-up. The planning and design phase will involve a recent review of relevant
literature, the creation of the structured study tool, the formulation of integrated training
program content in light of EBP, and prepare the teaching materials related to caring for MV
patients while taking into consideration the qualifications of targeted nurses and the
facilities in the selected setting. The educational tool and its content will be revised by
medical and nursing specialists to assure their content validity. Additionally, prior to
beginning the implementation phase, official approval and ethical approval will be requested.
The empirical phase will be implemented in two stages once official permission and ethical
approval are given to proceed with the proposed study:
The first stage will begin by randomly assigning the selected nurses to two paired groups
(study and control) 40 nurses each. The nurses in the control group are those who are taking
the current traditional in-service education (It is a daily, unstructured training sessions
given in clinical settings regarding caring for ICU patients). Another group will be taking
the EBNTP (study group). The second stage will begin with the selected ICU charge nurses
administering the study's pre-assessment for the study and control group in real clinical
settings using the study tool (EBNCAC). Following that, the recommended EBNTP will be
administered to the study group for one week, while the control group receives the previously
mentioned traditional in-service education.
Once empirical is complete, the 3rd phase will be initiated by evaluation & follow-up. It
will include immediate 1st post-assessment for the study and control group of nurses that
will measure the change expected to happen directly at the end of the program. Follow-up (2nd
post-assessment) will be started one month later, followed by 3rd post-assessment after three
months from the end of the EBNTP. 2nd and 3rd post-assessments aimed to measure the
sustainability of the change in the level of competency of nurses. In fact, the nurses
consider that they have learned if a sustainable, permanent change in their competency has
been observed.
After the empirical phase is finished, the third phase will begin with evaluation &
follow-up. It will include a first post-assessment that will be conducted immediately after
the program ends for both the study's nurses and the control group. The second
post-assessment for follow-up will begin one month later, and the third post-assessment will
begin three months after the EBNTP has ended. The purpose of the second and third
post-assessments was to measure the sustainability of the change in the level of competency
of nurses. The nurses actually believe that they have learned if there has been a noticeable,
sustainable, and permanent change in their competency.
Finally, in response to the aim of the study, the researcher will compare the scores of the
study group of nurses with the scores of the control group, which will be considered as
baseline data to determine the effect of given EBNTP.
Ethical Consideration:
The proposed study will only be carried out with official approval from the ethics committee.
Additionally, participation in the study is entirely optional, and each subject is free to
leave at any time. The subjects' informed consent will be acquired. Through the coding of all
data, the confidentiality and anonymity of the subjects are ensured; subjects are given the
assurance that their data won't be used in another study without their consent, that they'll
only be used for the research, and that the entire required sample in the study will be
followed until it's been analyzed. All information obtained will be kept private and will not
in any way influence their annual evaluation.
Data analysis The statistical package for social sciences (SPSS), version 21, will be used to
enter, classify, tabulate, and analyze the collected data. Descriptive statistics, such as
mean, standard deviation, frequency, and percentage, will be made. The study's hypotheses
were put to the test using tests of significance, such as the paired and unpaired t-test, the
chi-square test, and the ANOVA test. Between quantitative variables, Pearson's correlation
coefficient was used. At p 0.05, a significant level was taken into account.
