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Healthcare Intervention Research Proposal

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This assignment presents a comprehensive research proposal for a healthcare intervention study. The proposal outlines a detailed timeline spanning fourteen months, encompassing stages such as formulating the research question, intervention development, participant enrollment, intervention implementation, data collection, and data analysis. The plan includes specific activities for each month and utilizes SPSS software version 22 for statistical analysis. A budget breakdown is also provided, covering various expenses like overheads, meeting costs, office supplies, communications, staff time, travel, and dissemination.

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Running head- RESEARCH PROPOSAL
Research proposal on infection control among hospitalized patients
Name of the Student
Student ID
Name of the University
Author Note

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1RESEARCH PROPOSAL
Executive summary
Nosocomial or hospital acquired infections (HAIs) develop due to bacterial, fungal or viral
pathogens and are most commonly manifested in the form of blood stream infections, urinary
tract infection, pneumonia and surgical site infection. These occur due to contraction of
infections during stay at the hospital. Intensive care units are the most common regions where
these infections are found to prevail. This increases morbidity and mortality rates, and associated
healthcare costs. Chlorhexidine gluconate (CHG) is an effective antibiotic, usually applied for
disinfection of the skin before any surgery. This report encompasses a research proposal that
intends to determine the effectiveness of chlorhexidine in reducing such nosocomial infections in
ICUs.
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2RESEARCH PROPOSAL
Table of Contents
3. Research question/hypothesis and its purpose.............................................................................2
4. Literature review..........................................................................................................................3
5. Methodology, data collection and analysis method.....................................................................7
6. Validity......................................................................................................................................11
7. Ethical considerations................................................................................................................12
8. Dissemination............................................................................................................................13
9. Reflection...................................................................................................................................13
References......................................................................................................................................14
Appendix A- Proposed timeline....................................................................................................17
Appendix B- Research Budget......................................................................................................18
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3RESEARCH PROPOSAL
3. Research question/hypothesis and its purpose
3.1 “Effect of chlorhexidine bathing treatment in reducing hospital acquired
infections”.
3.2 Evidence based practice (EBP) refers to the interdisciplinary approach that focuses on
the conscientious use of recent, relevant and best available evidence that contribute to decision
making in patient care (Melnyk et al. 2012). This approach integrates several components,
namely, clinical expertise, values and preferences of the concerned patients, and a systematic
search along with critical analysis of the evidences that are considered to be most relevant to the
clinical context (Greenhalgh, Howick and Maskrey 2014). In the current scenario, effect of
chlorhexidine bathing in reducing infections in hospital setting will be based upon best available
evidences.
EBP involves 6 steps that assist nurses to enhance their clinical knowledge, thereby
enhancing their capabilities of participating in clinical decision making process. The first step
involves a thorough assessment of the patient by identifying the clinical problem. The second
step encompasses formulation of the clinical question after gaining a sound understanding of the
case scenario. The clinical question generally involves utilizing information on the risk factors,
diagnosis, management, prevention of the disorder in the healthcare setting. This is followed by
acquiring best available evidences by conducting an extensive database search, which forms the
third step. Several key terms and boolean operators are used to retrieve relevant articles. The
fourth step involves a critical appraisal of the selected articles by evaluating the strength and
weakness of each, followed by correlating them to the clinical question. This helps in
determining the way by which the findings of the evidences can be applied in clinical practice for

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4RESEARCH PROPOSAL
improving patient outcomes. The previous step is succeeded by returning to the patient in order
to correlate the collected evidences with preferences of the patient and clinical expertise, while
applying it to nursing practice. The final step focuses on evaluating the outcome in terms of the
expected results, and identification of factors that might act as a barrier in this context
(Guides.mclibrary.duke.edu 2018).
3.3 The results of the intended research proposal will positively contribute to EBP owing
to the fact that it will facilitate easy understanding the effectiveness of chlorhexidine bathing in
preventing infections, which will help healthcare professionals to implement its use in clinical
setting, thereby reducing the rates of HAIs, and improving health and wellbeing of the patients.
3.4 Proper evaluation of effectiveness of the antiseptic chlorhexidine will help all
healthcare professionals administer it upon the concerned patients, thereby reducing the
prevalence and incidence of HAIs. This in turn will improve patient safety and help in delivering
best healthcare services. The research will also add to the existing evidence that will facilitate
better clinical judgment and decision making (Loveday et al. 2014).
3.5 The infection control nurse will play an essential role in the present research. The
nurse will determine presence of bacteria and other pathogens in the body of the patient that
might have contributed to the infection. She will also help in collection and analysis of data upon
implementation of chlorhexidine supplement bathing treatment (Sopirala et al. 2014).
4. Literature review
4.1 Hospital acquired infections (HAIs) are developed during the course of
hospitalization. Thus, the primary objective of the healthcare administration is adoption of
strategies that help in infection control and hygiene maintenance (Tong et al. 2015).
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5RESEARCH PROPOSAL
A multicentered, randomized and non-blinded crossover trial was conducted by Climo et
al. (2013) in order to evaluate the effectiveness of daily bathing with washcloths that were
impregnated with chlorhexidine, on incidence of hospital acquired infections and acquisition of
multidrug resistant organisms (MDROs). The research was based on previous findings that
suggested the endemic nature of MDROs such as, vancomycin-resistant enterococcus (VRE) and
Staphylococcus aureus (MRSA) with methicillin resistance. The authors considered the fact that
clinical guidelines proposed by the Centers for Disease Control and Prevention (CDC)
encompassed adherence of strategies related to isolation precautions and hand hygiene, which
were difficult to sustain during frequent encounters with patients. Thus, the authors based their
research on the use of the antiseptic chlorhexidine that had previously demonstrated action
against enterococcus and S. aureus. The research was conducted among patients hospitalized in
bone transplantation units and across 6 ICUs, during 2007-2009. This was followed by
randomization of bathing units with washcloths that were impregnated using 2% chlorhexidine
gluconate (sample), and nonmicrobial washcloths (control) during a 6 month initial period. The
following 6 months contained administration of an alternate bathing product. The manufacturer’s
instructions were followed during bathing. The effects of intervention on the patients were
determined by personal monitoring of the skin conditions by nurse, which were later on graded
on a scale of 1-4. A statistical analysis of the VRE and MRSA acquisition and HAIs was
performed using the PROC GENMOD method. Result findings suggested presence of 165 new
cases of VRE or MRSA among controls, upon comparison with sample group. The intervention
group demonstrated a 23% reduction in overall infection acquisition (P=0.03). There was a 25%
reduction in the overall VRE acquisition rates during the intervention period. Similar reductions
were also demonstrated in the sample group regarding MRSA acquisition (19%). Furthermore,
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6RESEARCH PROPOSAL
rate of bloodstream infections also showed a significant decrease in the intervention period
(28%). Thus, the study helped to establish that bathing patients with chlorhexidine-impregnated
washcloths, on a regular basis helped in reducing risks of HAIs.
Huang et al. (2016) also reviewed 15 studies that included 12 quasi-experimental studies
and 3 RCTs in order to investigate the efficacy of daily bathing in chlorhexidine antiseptic for
prevention of healthcare-associated infection among patients admitted to ICUs. The authors
conducted the systematic review based on the fact that HAIs are the leading causes of morbidity
and mortality among hospitalized patients. Patients admitted to the intensive care units are at an
increased likelihood of getting affected by these infections due to weak immune system,
misplacement of invasive devices and co-morbidity. The review was focused on previous
findings that established the use of chlorhexidine gluconate (CHG) in effective prevention of
microbial activity in case of catheter related bloodstream infections, surgical site infections and
MDROs. The systematic review was based on PRISMA statement (Preferred Reporting Items for
Systematic Reviews and Meta-analyses), and its protocol was based registered on PROSPERO.
An exhaustive search for relevant articles was carried out in EMBASE, PubMed, and the
Cochrane Central Register of Controlled Trials databases, using specific key words. Articles
published in English and including studies conducted on human subjects were selected. After
conducting data extraction and quality assessment by two authors, a statistical analysis was
performed to pool the data. Results revealed that the included studies were mostly conducted in
the US and used 2% chlorhexidine impregnated washcloths as the intervention. Findings from 11
studies showed a significant difference in CRBSI rates between the intervention group and the
control (RR, 0.50; 95% CI, 0.36 to 0.71; p < 0.0001). According to results obtained from 6
studies, bathing in CHG was found to significantly reduce rates of VAP infection, upon

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7RESEARCH PROPOSAL
comparison with water, soap or other controls (RR, 0.71; 95% CI, 0.56 to 0.88; p = 0.002).
Similar results were also demonstrated by 8 studies that suggested that the intervention was
effective in reducing risks associated with MRSA acquisition in the sample (RR, 0.78; 95% CI,
0.68 to 0.91; p = 0.001). Bathing in chlorhexidine was also found to reduce VRE acquisition by
considerable amounts. Furthermore, the review results also suggested that daily bathing in the
antiseptic resulted in lower mortality rates in the hospital and also prevented occurrence of
adverse events among patients. Thus, the meta-analysis helped to establish that bathing in CHG
is significantly associated with lower risks of hospital acquired infections.
Martínez-Reséndez et al. (2014) conducted a study over a period of 18 months to assess
the impacts of daily bathing in chlorhexidine and compliance to hand hygiene on the rates of
nosocomial infection rates among critically ill patients. The study was based on the fact that
nosocomial infections account for maximum rates of mortality and morbidity and affect more
than 10% hospitalized patients. The researchers focused on the use of chlorhexidine in the form
of a topical antiseptic for antimicrobial activity against pathogens. Findings from previous
studies that demonstrated effectiveness of CHG baths in reducing nosocomial and bloodstream
infections in critically ill patients formed the basis of this research. The researchers divided the
study into three intervention periods (6 months for each) namely, a pre-intervention, intervention
and pos-tintervention. Patients were subjected to bathing in soap and water during the pre- and
post-intervention phases. Collection of clinical and demographic data from all patients was
followed by surveillance of infections that were defined according to the critieria given by CDC.
A statistical analysis using the Wilcoxon’s rank sum test suggested that the mean hospitalization
length was 7.89 days, 8.73 days and 9.67 days in the three phases. Findings demonstrated a
significant reduction in VAP infection rates during the intervention period. Furthermore, gram-
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8RESEARCH PROPOSAL
negative bacteria were found predominant during the phase, in 21 cases. A reduction was also
observed in the number of Acinetobacter baumannii in the intervention period (P=0.02).
Significant reduction in VAP infections due to A. baumannii (P=0.0204) and CAUTI due to
Candida spp. (P=0.0005) demonstrated effectiveness of the chlorhexidine bathing method in the
context. Furthermore, significant difference in compliance demonstrated by nurses to the
protocols also supported success of the research methodology. Thus, the study helped
resesarchers to state that CHG bathing protocol helped in reducing global infection rates and the
rates of CAUTI and VAP among critically ill patients.
5. Methodology, data collection and analysis method
5.1 The methodology will involve a cluster randomized and crossover controlled trial that
will be conducted among patients admitted to intensive care units (ICUs) across the selected
medical care centres. Primary outcome includes measurement of three nosocomial infections
namely, ventilator associated pneumonia (VAP), central line associated bloodstream infection
(CLASBSI) and catheter associated urinary tract infection (CAUTI). Nosocomial infections or
HAIs refer to all kinds of infections that are acquired in a healthcare facility. These nosocomial
infections will be measured due to the fact that they account for more than 99,000 deaths per
year. The Centers for Disease Control and Prevention National Healthcare Safety Network
provides specific definitions on the different types of infections that can occur in a person
(Weiner et al. 2016). The methodology will therefore encompass an extensive training of the
associated infection control nurses, who will determine presence of infections among the patients
based on the aforementioned definitions. Secondary outcomes will include the rate of infection
among all patients, contamination of blood culture, bloodstream infections, length of hospital
stay and CHG bathing skills demonstrated by the nurses. The skills assessment questionnaire will
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9RESEARCH PROPOSAL
help to evaluate the effectiveness of training in compliance to the required protocol, which in
turn affects health outcome of the patients.
5.2 Based on the standards of infection, mentioned by CDC, the research will be entirely
quantitative, using a case control design that will help in identifying the effectiveness of the
proposed intervention (chlorhexidine bathing treatment) on the sample group. The primary
objective of a quantitiative research is focused on determination of the relationship or association
between an independent variable and its outcome (dependent variable). The research design that
will be implemented will be purely descriptive. Reasons for not selecting a qualitative approach
for this study are based on the fact that a qualitative design usually employs use of semi-
structured or unstructured questionnaires or surveys for uncovering prevalent trends in opinion
(Arghode 2012). Moreover, qualitative research focuses on collection of data that is quite time
consuming.
Thus, a restricted budget and time constraint makes it necessary to limit qualitative
studies to small sample sizes. Including less number of people in the research also makes it
difficult to generalize the findings to a larger population (McCusker and Gunaydin 2015). Using
a quantitiative approach to conduct the research among hospitalized patients to evaluate
effectiveness of the intervention in infection control will thus be a more objective and reliable
step. It will help in determining relationship between the variables and will establish cause and
effect (Wisdom et al. 2012).
5.3 The study will involve around 600 intensive care patients admitted to neurological
units, trauma units and surgical units across 3 tertiary medical centres in the region. Each unit
will be staffed by critical care nursing professionals and nurse practitioners with 24-hour

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10RESEARCH PROPOSAL
coverage by physicians. All patients will be enrolled in this study based on those who have been
admitted to ICU during the time frame, without meeting the exclusion criteria. Patient enrolment
will be conducted during the admission procedure and before they receive their first bath in the
intensive care unit.
The inclusion criteria are as follows:
All patients admitted to intensive care units
All patients regardless of their gender
Patients with intact skin tissues
The exclusion criteria are as follows:
Patients with previous history of hypersensitivity to chlorhexidine gluconate
Patients being cared for in burn units or with TEN/SJS or in non-burn ICUs.
Patients with indwelling lumbar or epidural drain
Infants weighing less than 1500 grams or younger than 10 days
Patients who refuse to sign the informed consent for the study
5.4 Survival of the participants will be evaluated at the end of 4 months. Participants
discharged prior to 4 months will be contacted later on to ascertain their survival status. The
infection control nurses will be asked to work in collaboration in order to designate the infections
observed among the participants using the existing CDC definitions. Owing to the differences
that exist in the appearance and scent of 2% chlorhexidine impregnated wash cloths, it will not
be possible to blind the patients to the study. After randomization of the participants to two
groups, one group will be subjected to chlorhexidie bathing, while the other will be exposed to
control bathing using soap and water. In addition to instructing the nurses to record presence of
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11RESEARCH PROPOSAL
infections, the rates of blood culture contamination will be obtained from all patients by
collecting blood cultures from the participants.
Presence of pneumonia among the patients will also be recorded. Furthermore, help will be
taken from the nurses to record presence of urinary tract infections among patients with
prolonged use of catheters. In order to further validate whether the nurses are appropriately
following guidelines suggested for CHG bathing, an interview will conducted. It will usually
include questions on the bathing practices that are demonstrated by the nurses. Deviations from
the protocol will be recorded in a timely manner to eliminate misleading results. Furthermore,
incidence of adverse events will also be monitored.
5.5 Although the study is a quantitative one, three questions that will be asked while
interviewing the nurses are as follows:
Have you ever used soap in combination with a 2% CHG washcloth? If yes, when
and how often?
Have you ever wiped off the CHG after bathing the patient?
If a patient requests for a second bath or freshening up, do you use a different
product or CHG cloths?
5.6 Descriptive statistics such as, standard deviation and mean will be conducted for the
baseline characteristics and demographics. These will be compared between the groups using a
Chi-square test. Primary statistical analysis will include use of a Poisson regression model for
comparing infection rates between the control and intervention group (Zou and Donner 2013). A
Mann-Whitney U test will be conducted for estimating the secondary outcomes such as, length
of hospitalization, survivial rates, blood culture contamination and rates of HAIs upon use of
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12RESEARCH PROPOSAL
CHG (Corder and Foreman 2014). A Poisson regression model will be used to adjust estimates
of CHG. This statistical analysis will be conducted using IBM SPSS statistics version 22
(TannerSmith and Tipton 2014).
5.7 Potential uses of the data are as follows:
It will help nurses gain a sound understanding on the bathing protocols that need to be
followed while providing care to critically ill patients
Positive findings of CHG effect will help in managing nosocomial infections in future
practice
5.8 The Data Collection Policy, Government of Western Australia will be used.
6. Validity
6.1 The independent variable for this study is use of 2% chlorhexidine impregnated
bathing cloths. The dependent variables are rates of HAIs and survival rates among patients.
6.2 Following are the obstacles in the study:
Obstacle 1- Most patients have a stigma related to physical contact with nurses who assist
in bathing
Solution 1- Development of a psychological understanding and good rapport with
patients and allowing family member to stay during the bathing process
Obstacle 2- Lack of adequate funds
Solution 2- Strategic budget planning

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13RESEARCH PROPOSAL
6.3 One major advantage of the large sample size in the case-control study is the fact that it
will be less time consuming and the findings can be generalized for a larger population.
6.4 One disadvantage is related to inability to blind the participants and nurses to the
intervention.
6.5 Using a one-to-one pair matching method to compare subjects in the control and
intervention for the baseline characteristics will establish validity.
7. Ethical considerations
7.1 Two needs are as follows:
Physical need- Severe persistent pain
Solution- Administration of analgesics
Emotional need- Anxiety that makes them show non-compliance to the intervention
Solution- Making them understand the purpose of the research
7.2 Participants following certain faiths like Judaism or Islam consider it inappropriate to
have bodily contact between unrelated people. It is regarded as violation of their religious views.
Thus, assistance will be taken from community workers or nurses belonging to these religions
and ethnicities to help the patients cooperate in the study.
7.3 The NMBA Enrolled nurse standards for practice, ANMC Code of Conduct, NMBA
Regulatory Authority Standards for Practice and ANMC Code of Ethics will be consulted.
7.4 National Health and Medical Research Council (NHMRC) and Australian Code for the
Responsible Conduct of Research.
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14RESEARCH PROPOSAL
7.5 National Statement on Ethical Conduct in Human research will be consulted.
7.6 All researchers will be asked to act according to the best interest of all respondents, while
maintaining their autonomy and confidentiality. Monitoring will also be carried out to ensure
patient safety.
7.7 Personal details of the participants will not be disclosed by electronic, print or any other
forms, during and after the research.
8. Dissemination
8.3 Findings of the research will be disseminated, and shared with the University under
which it is registered. The completed research will be sent to reputed international journals for
publication.
9. Reflection
9.1 I worked in collaboration with the healthcare professionals working at the three
tertiary medical centres (nurses) and with my peers. It fostered effective working relationship
during the study.
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15RESEARCH PROPOSAL
References
Arghode, V., 2012. Qualitative and Quantitative Research: Paradigmatic Differences. Global
Education Journal, 2012(4), pp.155-163.
Brown, C.E., Wickline, M.A., Ecoff, L. and Glaser, D., 2009. Nursing practice, knowledge,
attitudes and perceived barriers to evidencebased practice at an academic medical center.
Journal of advanced nursing, 65(2), pp.371-381.
Climo, M. W., Yokoe, D. S., Warren, D. K., Perl, T. M., Bolon, M., Herwaldt, L. A., ... & Wong,
E. S. (2013). Effect of daily chlorhexidine bathing on hospital-acquired infection. New England
Journal of Medicine, 368(6), 533-542.
Corder, G.W. and Foreman, D.I., 2014. Nonparametric statistics: A step-by-step approach. John
Wiley & Sons, pp.212-243.
Greenhalgh, T., Howick, J. and Maskrey, N., 2014. Evidence based medicine: a movement in
crisis?. Bmj, 348, p.g3725.
Guides.mclibrary.duke.edu (2018). LibGuides: Introduction to Evidence-Based Practice :
Overview. [online] Guides.mclibrary.duke.edu. Available at:
http://guides.mclibrary.duke.edu/c.php?g=158201&p=1036021 [Accessed 3 Feb. 2018].
Huang, H.P., Chen, B., Wang, H.Y. and He, M., 2016. The efficacy of daily chlorhexidine
bathing for preventing healthcare-associated infections in adult intensive care units. The Korean
journal of internal medicine, 31(6), p.1159.

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Loveday, H.P., Wilson, J., Pratt, R.J., Golsorkhi, M., Tingle, A., Bak, A., Browne, J., Prieto, J.
and Wilcox, M., 2014. epic3: national evidence-based guidelines for preventing healthcare-
associated infections in NHS hospitals in England. Journal of Hospital Infection, 86, pp.S1-S70.
Martínez-Reséndez, M.F., Garza-González, E., Mendoza-Olazaran, S., Herrera-Guerra, A.,
Rodríguez-López, J.M., Pérez-Rodriguez, E., Mercado-Longoria, R. and Camacho-Ortiz, A.,
2014. Impact of daily chlorhexidine baths and hand hygiene compliance on nosocomial infection
rates in critically ill patients. American journal of infection control, 42(7), pp.713-717.
McCusker, K. and Gunaydin, S., 2015. Research using qualitative, quantitative or mixed
methods and choice based on the research. Perfusion, 30(7), pp.537-542.
Melnyk, B.M., Fineout-Overholt, E., Gallagher-Ford, L. and Kaplan, L., 2012. The state of
evidence-based practice in US nurses: critical implications for nurse leaders and educators.
Journal of Nursing Administration, 42(9), pp.410-417.
Sopirala, M.M., Yahle-Dunbar, L., Smyer, J., Wellington, L., Dickman, J., Zikri, N., Martin, J.,
Kulich, P., Taylor, D., Mekhjian, H. and Nash, M., 2014. Infection control link nurse program:
an interdisciplinary approach in targeting health care-acquired infection. American journal of
infection control, 42(4), pp.353-359.
TannerSmith, E.E. and Tipton, E., 2014. Robust variance estimation with dependent effect
sizes: practical considerations including a software tutorial in Stata and SPSS. Research
Synthesis Methods, 5(1), pp.13-30.
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Tong, S.Y., Davis, J.S., Eichenberger, E., Holland, T.L. and Fowler, V.G., 2015. Staphylococcus
aureus infections: epidemiology, pathophysiology, clinical manifestations, and management.
Clinical microbiology reviews, 28(3), pp.603-661.
Weiner, L.M., Webb, A.K., Limbago, B., Dudeck, M.A., Patel, J., Kallen, A.J., Edwards, J.R.
and Sievert, D.M., 2016. Antimicrobial-resistant pathogens associated with healthcare-associated
infections: summary of data reported to the National Healthcare Safety Network at the Centers
for Disease Control and Prevention, 2011–2014. infection control & hospital epidemiology,
37(11), pp.1288-1301.
Wisdom, J.P., Cavaleri, M.A., Onwuegbuzie, A.J. and Green, C.A., 2012. Methodological
reporting in qualitative, quantitative, and mixed methods health services research articles. Health
services research, 47(2), pp.721-745.
Zou, G.Y. and Donner, A., 2013. Extension of the modified Poisson regression model to
prospective studies with correlated binary data. Statistical methods in medical research, 22(6),
pp.661-670.
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Appendix A- Proposed timeline
Time Research stage Actions taken
Month 1 Ethical
clearance
Presenting the research objective to the ethical council
Month 2 Project
framework
Formulating the research question and seeking approval from all
hospitals where the study will be conducted
Month 3 Intervention
development
Conducting extensive literature review on the proposed
intervention
Month 4 Participant
enrolment
Enrolling 600 participants, 200 from each tertiary care centre,
following informed consent
Month
5, 6, 7
and 8
Intervention
implemented
Following the aforementioned study methodology
Month 9
and 10
Data collection Recording primary and secondary outcomes

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19RESEARCH PROPOSAL
Month
11-13
Data analysis Statistical analysis using SPSS software version 22
Month
14
Preparation of
the article
Writing the research study and sending it to journals
Appendix B- Research Budget
Research Budget
Overheads
(rent of office space, maintenance, etc.)
< $500
$500 - $ 2,000
$2,000 - $5,000
> $5,000
Research meeting expenses < $500
$500 - $ 2,000
$2,000-$5,000
>$5,000
Office equipment and supplies
(printing &photocopying)
< $500
$500 - $ 2,000
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$2,000-$5,000
>$5,000
Communications costs
(phone/fax/internet/postage)
< $500
$500 - $ 2,000
$2,000-$5,000
>$5,000
Staff time
(professional and support, including
benefits)
< $5,000
$5,000 - $ 20,000
$20,000 -$50,000
>$50,000
Travel and transportation < $500
$500 - $ 2,000
$2,000 - $5,000
> $5,000
Dissemination
(how will it be published or distributed,
e.g. rent for conference room)
< $500
$500 - $ 2,000
$2,000 - $5,000
> $5,000
TOTAL (approximate amount) $___40500__
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