William defined medication error as any error in prescribing, dispensing or administration of a drug, irrespective of whether such errors lead to adverse consequences or not. A medication error could lead to severe consequence to both the patient and the hospital. Patient could suffer from side effects of the wrong medication, permanent injuries could occur or in the worst case scenario, death of the patient. As a result of medication error, patient could have an extended stay in the hospital and the hospital is liable to pay damages and incur the cost of hospital stay of the patient.
When medication errors occur, it can affect the patient’s confidence and trust on the healthcare team. There are many reported case of medication error in the media and this could damage the hospital reputation.
Studies have been done and the findings have shown that the nursing department is the main department involved when a medication error had occurred. Drug administration is often associated as the higher risk areas in nursing practice. In the process of prescribing to the dispensing and the administration of the drug, the pharmacist or nurse may intercept prescribing errors and the nurse may catch dispensing errors but nurses are often the final individual involved before administering of the drug to the patient.
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Numerous other studies have been done to determine the cause of medication error. Policies and procedures have since been introduced to reduce medication error. Nursing schools have taken steps to improve the knowledge of a nursing student in pharmacology and hospitals have addressed issues that contributed to medication error. A local government hospital in Singapore for example, has taken huge steps to improve and reduce medication error.
In that hospital for example, nurses are required to wear medication vest with a “do not disturb” advice written on the vest. This is to indicate to patient or relative and fellow healthcare professionals to not distract the nurse who is serving medication and this will allow the nurse to focus while administrating drug. Technological support such as the computerised physician order entry (CPOE) system has also been introduced to assist the nurse during the process of administration of the drug. To improve the knowledge on pharmacology, regular discussion and in-service talks are held.
Despite implementing many changes, medication error is still on the rise. For this study, the researcher aim to reduce medication error by using a non experimental, descriptive and quantitative research and look at the nurse itself and identify other possible factors that may have contributed to medication error. An important area for research and focus for this paper is to find out if there is any association between irregular work shift pattern among nurses and medication error in the ward.
Definition of term used in shift work.
In Singapore General Hospital, morning shift is from 0700hrs-1600hrs while afternoon shift is from 1300hrs-2000hrs. Night shift will be from 2100hrs to 0730hrs.
Irregular work shift pattern: Frequent alternating and rotating of shift from morning to afternoon shift or vice-versa.
Rotating shift: Work pattern consisting of days, afternoon and night shifts. Shift can be from morning to afternoon or afternoon to morning. Rotation can be fast for example, a staff can work afternoon shift today and be morning shift on the next day and this could go on for a couple of days before the staff off days.
Introduction
In a society and environment where services are to be provided around the clock, has lead to an increase in demand for shift work. It is important for the organisation to plan a good staff schedule to meet the demands of the clients. This is especially so in healthcare industry. With reports of shortage number of nurses from around the world, an effective scheduling shift is crucial for the success of a hospital. Hospital wards for example, need to be staffed 24 hours, 7 days a week, often with limited number of nurses (Clark and Walker, 2011). Studies have been conducted and it showed that shift work can have significant impact on the nurse. It is important to understand the ill effects of shift work on the nurse as patient’s life is at risk if nurses are made to work undesirable work schedules. It affects the nurse performance at work. Long hours, fatigues and lack of rest or break time to recuperate between shifts are associated with an increased risk of errors. Fatigue is recognised as one of the contributing factor in patient safety incident such as medication error. Absenteeism is also a major problem among nurses in hospital. Nurses who worked shift work have been found to have a higher level of absenteeism rate.
Significance of the study
There’s a limited number of study done to concretely relate that there is an association between irregular work shift pattern and medication error. If this study is suggestive that there is an association between irregular work shift pattern and medication error, the researcher hopes that the Ministry of Health (MOH) can ensure that steps are taken by the employers to reduce the risks of shift work of the nurses. Employers need to be aware of the potential safety impact, of a nurse working on shift and the need to manage shift work to improve patient safety
A review of literature on the topic was conducted. The literature review identified four key factors that could affect a nurse working on shift:
Circadian rhythms
Sleep Deprivation
Fatigue, errors and accident
Health
Circadian rhythms
Many of the health and safety impacts of shift work are associated with a disruption of the body clock or the circadian rhythm. Circadian rhythms are controlled by our hypothalamus in the brain. The circadian rhythms of shift workers working nights or rotating shifts can be disrupted which can lead to sleep disturbances, fatigues and health effects.
There are optimal shift patterns which can help mitigate disruption to the circadian rhythms and therefore reduce the risks, such as putting in place forward rotating shift patterns- in other words, moving from early to late to night shifts rather than reverse.
Sleep deprivation
Studies have shown that most adults require between seven to eight hours a sleep per day. Sleep is protective as it allows the body and mind to recuperate and rest. Numerous studies pertaining to shift work have indicated that shift worker slept lesser than the required seven to eight hours and the quality of the sleep is poorer. Sleep deprivation can be accumulated and this is one of the contributing factors to poor health, fatigue or burnout.
Fatigue, errors and accidents
Fatigue is defined as the decline in mental performance that results from long working hours, lack of sleep, poor quality sleep or poorly designed shift work causing disruption of the internal body clock. Fatigues have shown that it cans slower a person’s reaction, decreasing one’s vigilance, increased risk taking behaviours, impaired problem solving ability and it can affect a person’s decision making capacity. In healthcare, staff fatigue has been recognised as a contributory factor to patient safety incidents including drug errors (NPSA, 2004).
Health
Numerous studies have shown that shift work can have a significant impact on health of the shift worker. It is widely accepted that poorly managed shift work can have a negative impact on mental health, cardiovascular system, gastrointestinal system and reproductive system. Numerous other studies have shown that with the affects of shift work on health, lead to an increase in absenteeism rate of the shift worker. This will result in staffs that are on day off, being called in to work to replace the staff that went for sick leave or staff to be shifted to work on a different schedule or nurses having to stretch and care for more patient. This can lead to medication error.
3. What kind of research methods would be most useful for your topic?
Polit and Beck (2010, pg 16) define research method as “techniques researchers use to structure a study and to gather and analyze information relevant to the research question”. A quantitative approach using a descriptive design is proposed for this study.
The researcher chose to conduct this study at Singapore General Hospital (SGH). This hospital is chosen because it is Singapore’s flagship tertiary hospital with an estimated number of 1521 beds and 3627 nurses.
The researcher will sought consent and approval from MOH, SGH Division of Research and the university ethical board to conduct the study. Once permission is granted, the researcher will approach MOH for funding. Upon approval, the researcher will hire a team of nurses and an expert statistician to assist with the study. Nurses hired will be trained to be data collectors and will be given policies and protocol to adhere to. The statistician will assist in the statistical analysis. Computer software called Statistical Package for Social Sciences (SSPS) will be used. Power analysis will also be used by the statistician to determine the appropriate sample size required for this study.
A questionnaire will be used as the data collection method. Questionnaire was chosen because opportunity for biasness will be lesser as the questions will be presented in a consistent manner (Burns and Grove, 2011). It will also offer rights to anonymity and confidentiality as names are not required to be written on the questionnaire. However there are some limitations when using the questionnaire because the options given are provided by the researcher and is brief. This might affect the validity and accuracy of the data as it might not reflect the true opinion of the subject. The researcher will gather the samples through the data collected through the use of questionnaire.
Structured interview will also be conducted for this study on the basis of the literature review that examined other possible ill-effects of shift work and how it might have led to the medication error. This structured interview will allow the subjects to better express themselves and give a more accurate account on topic. To reduce recall biasness for this study, interviews will be conducted within 3 days of the medication error incident. All interviews will be conducted in a meeting room provided by the hospital. This is to ensure that the right to privacy and right to anonymity and confidentiality are adhered to.
3.1 Most appropriate approach.
Burns and Grove (2011, pg 49) define research design as “a blueprint for the conduct of a study that maximizes control over factors that could interfere with the study’s desired outcome”.
For this study, a non-experimental, descriptive, quantitative approach was selected.
Non experimental
The researcher chose a non experimental study because the researcher is more interested in exploring possible relationships between irregular work shift pattern and medication error than to test a possible solution to the problem (Polit and Beck, 2010)
Descriptive
Burns and Grove (2011, pg 35) describe descriptive as a design used to help identify new meaning and problems with current practice with a view to improve practice outcomes in the near future. A descriptive research is chosen because limited numbers of research have been done and little is known if there is any association between irregular work shift pattern and medication error in the ward. Outcome of this study can provide a basis for future research.
Quantitative
In order to undertake the above study, a quantitative approach was selected by the researcher. Burns and Grove (2011, pg 34) describe quantitative research as “a formal, objective, rigorous, systematic process in which numerical data are used to obtain information about the world”. A quantitative approach is best suited for this topic because it allows the researcher to measure and analyze the data using statistics and rule out other possible factors that could contribute to medication error. This method will also allow the researcher to study in detail, the relationship between the independent and dependent variable and be more objective about the findings of the research.
Retrospective study
A retrospective design was chosen. Polit and Beck (2010, pg 235) describe retrospective study as “a phenomenon observed in the present is linked to phenomena occurring in the past”. This design is better suited for this topic because the data will be collected after the medication error had occurred. The researcher will focus on the presently occurring outcome, and then tries to ascertain if there is any association with the irregular work shit pattern of the nurse. The researcher had no control over the independent variable, which is the irregular work shift pattern of the subject as the presumed causative factor had already occurred.
.3.2 Who would you need to recruit as participants? What sort of sample will you need and how will you recruit them?
Permission will be obtained to conduct the study from MOH, the hospital ethical committee, the medical board and nursing directors. Upon approval, the researcher will obtained permission to have access to the Risk Management System (RMS). This will enable the researcher to gather the data required to recruit the subjects.
At the hospital, any clinical incident for example, medication error, must be reported in the RMS by the nurse involved and his/her ward supervisors. With the support of the nursing directors, the researcher will seek cooperation from ward supervisors from across the hospital to participate in this study. The aim, topic and details of the study will be e-mailed to the ward supervisors and details of the study were to be shared to the ward staff during roll-call before the start of every shift.
The researcher will access to the RMS each day to monitor for any reported cases of medication error. If a medication error had occurred in the ward, the researcher will e-mail the ward manager involved and will obtain consent to conduct the study. Upon getting the consent, the trained data collector will be sent to the ward with a set of questionnaire that is stored in a laptop provided by the researcher. The data collector will than asked the nurse who had committed the medication error to complete the questionnaire in a quiet comfortable environment. The data collector will than photocopy 2 weeks of the nurse duty roster prior to the medication error incident.
With the help of a statistician, the researcher will than analyze the questionnaire and the working schedule of the nurse involved and decides if the subject meets the criteria to be included in the sample for the study.
Population and Sample
Kerlinger and Lee (2000), describe population as all elements (individuals, objects or substances) that meet specific set of criteria for an inclusion in a study. The population for this study will be nurses who had committed a medication error in the ward and have reported the incident on the RMS.
Burns and Grove (2011, pg 51) defines a sample as “a subset of the population that is selected for a particular study, and the members of a sample are the subjects or participants”. In this study, the samples are nurses who had committed a medication error and met the sampling criteria during the period of data collection. The authors add that sampling involves selecting a group of people, events, behaviours or element with which to conduct a study (Burns and Grove, 2011).
Sampling Criteria
According to Burns and Grove (2011, pg 291), sampling criteria are “characteristics essential for eligibility or membership in the target population”. For this study, the subject had to meet the following criteria to be included in the sample.
Inclusion criteria:
SGH nursing staff.
Have conducted a medication error and reported the incident in the RMS.
Have worked irregular work shift pattern for 2 consecutive weeks.
Can be of either gender or any race.
Have at least 1 year of working experience in the same ward/discipline.
Willing to participate in the research.
Exclusion criteria:
Agency nurses
Subjects who did not meet the criteria will be excluded from the study.
Sampling method
For this study, the researcher selected to use purposive sampling. Burns and Grove (2011) describe purposive sampling as a “judgemental” or “selective sampling”. This method is appropriate for this study because proportionality is not a major concern and it will enable the researcher to purposively select the targeted sample quickly and study in-depth with regards to the topic.
Issues that might affect sample recruitment and sample size
Issues that might affect the sample recruitment and sample size would be the unreported cases of medication error.
Subjects who met the sampling criteria might be coerced to participate in the research due to the influence from the ward supervisors. They might also fear that if they did not participate in the study, they could be punished and it might affect their job performances.
Subjects who met the sampling criteria might be not willing to participate in the study due to time constraint.
3.3 Data collection methods.
Burns and Grove (2011, pg 361) define data collection as a “process of acquiring the subjects and collecting the data for the study”. Burns and Grove (2011, pg 362) adds that during the duration of data collection, “researcher should focus on obtaining subjects, training data collectors, collecting data in a consistent way, maintaining research controls as indicated in the study design, protecting the integrity (or validity) of the study and solving problems that threaten to disrupt the study”.
A team of nurses will be hired to be data collector. They will be trained and policies and protocols will be given for them to adhere to.
Questionnaires design by the researcher will be used as the data collection method. Burns and Grove (2011, pg 353), describe questionnaire as “a printed self-report from designed to elicit information through written or verbal responses of the subject. The information obtained from the questionnaire is similar to that obtained by an interview, but the questions tend to have less depth”.
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Questionnaires tend to have a low response rate. In an attempt to overcome this problem, the researcher will create the questionnaire using Microsoft Word and the questionnaire will be stored in the laptop provided by the researcher. Data collectors will go to the ward personally with the laptop and the necessary requisite needed and subjects are required to complete the questionnaire using the laptop provided. Subjects are required to complete the questionnaire online so as to minimise human error when the statistician is collating the data. To prevent the employers from accessing to the data given by the subject, the data collector are instructed by the researcher to bring the subject to quiet room, preferably the tutorial room in the ward, and stay with the subject whilst the subject is completing the question. A “do not disturb” sign will be placed on the door. Upon completion of the questionnaire, the data collector will save the data in a separate folder with passwords and only the statistician and the researcher will have access to it.
Validity
Before the questionnaire is deem suitable to be used and distributed across the hospital, a panel of experts, comprising of a doctor, a senior nurse clinician, a senior pharmacist and a representative from the ethics committee, will review the questions in the questionnaire. The panel of experts will assess the content validity of the questions and the researcher will seek for constructive feedback and will address issues recommended by the panel of experts. This is done to ensure that questions asked are clear and is easy for subject to understand.
Reliability
According to Burns and Grove (2011, pg 332), “reliability is concerned with the consistency of the measurement method”. The same set of the online questionnaires will then be tested out on two wards to seek the consistency in the respective responses. The trained data collector will ensure that the questionnaires will be done in a quiet comfortable environment to prevent interruption.
Structure of the question
The questionnaire will consist of mostly close-ended question and a few open ended questions and is divided into 3 sections.
In section A, a Yes or No option will be provided and subjects are required to tick the empty boxes provided. Questions will be asked to determine if the subject meet the sample criteria.
In section B, a True or False option will be provided and subjects are required to tick the empty boxes provided. Questions will be asked to evaluate subject knowledge on hospital polices and protocols introduced to reduce medication error.
In section C, the researcher will use a Likert-type scale to gather data. Six different response options ranging from disagree to strongly disagree will be provided by the researcher. Questions will be asked on subject’s attitudes and views on the impact of irregular work shift pattern and how it affects the nurse performance at work. In section D,
Close-ended questions are questions designed by the researcher with available option to choose from. It is used because this is a descriptive study and it will enable the researcher, with the help of a statistician, to gather data and to understand in-depth regarding a broad spectrum of information and situation known by the subject (Burns and Grove, 2011).
Open-ended questions are questions which require written responses from the subject. Open-ended questions are also used for this study because it will enable the researcher to gather information about beliefs, attitudes opinions, knowledge, or intention of the subjects with regard to the irregular work shift pattern (Burns and Grove, 2011).
Subjects will than undergo a structured interview session on a separate date with the researcher to encourage the subject to elaborate further on how irregular working schedule can affect the performance of a nurse in the ward. According to Burns and Grove (2011, pg 350), “an interview involves verbal communication between the researcher and the subject during which information is provided to the researcher”. A structured interview is needed for this study because it will enable the researcher to explore in-depth and elicit more information from the sample size (Burns and Grove, 2011). To reduce recall biasness for this study, interviews will be conducted within 3 days of the medication error incident
3.4 Data analysis.
According to Burns and Groves (2011, pg 52), “data analysis reduces, organizes, and gives meaning to the data”. After the data was collected from the subject duty roster, questionnaire and the interview, the statistician will organize and analyzed the data using descriptive statistic. Analysis of quantitative data is carried out using numbers. The reply to each of the question in Section A and B of the questionnaire will be coded using numbers. The reply to each question at Section C will be coded using numbers on an ordinal scale of 1 to 6. The statistician will assist in collating the data using Statistical Package for Social Sciences (SSPS). The frequency of a particular response to a question will be calculated as a percentage and the data will be illustrated using graph and bar charts.
4. Deliverables.
This study is important because there are very limited numbers of studies associating irregular work shit pattern and medication error. Although policies and steps are put in place to reduce the number of medication error in the hospital, the number of medication error is still on the rise.
Using the findings of this study and with the approval of MOH, the hospital can explore of alternative ways to reduce medication error. Cost savings should not be the primary concern but the safety of the staff and patients must be considered.
The findings of this study can be used to improve the nurse’s performance at the ward level, thus leading to a better quality care for the patients. The findings of this study might also decrease the absenteeism rate of the nurse.
At the hospital, Trend care system is used by nursing supervisors for scheduling of staff roster and the allocation of staff at ward level. Using trend care system, the ward supervisor can schedule staff to rotate shifts in every two to three days or in every three to four week. The nurse supervisor should avoid weekly or fortnightly working shift pattern unless requested by the staff. Where possible, adopt a morning to afternoon shift working schedule instead of having the staff to work afternoon followed by morning shift. This is to ensure that staffs have adequate rest.
Human Resource (HR) department could also think of alternative ways assist wards that is understaffed without having to call in staff to work on their scheduled off days.
5. Scheduling of the study
The total period of this study will be over 24 months. In the first 3 months of the study, the researcher will write a written permission to the hospital and seek cooperation to conduct the study. During the fourth month, the researcher will sought approval from the hospital, the health ministry and the university institutional review board (IRB) which will be discussed on point 6 under ethical considerations. The researcher will than hire team of nurses and train them to be data collector. A statistician will also be hired for this study. Recruitment of study participants & data collection will commence on the 9th month of the study and will go on for a period of 1 year. The statistician will than assist in statistical analysis. Writing of results will take place on the 22nd month to the 23rd month and the researcher will submit the result of the study to MOH on the 24th month. During this period, there will be research team meetings and further development/consolidation of project and updating of literature review on every last Saturday of every month.
Details of cost
Project Researcher
$1000
Statistician (for 1 year)
$1000
Nurses x 3
$800
Laptop and Printer
$800
Stationeries
$100
SPSS software
$100
Total
$5400
Table 1: Summary of Project Activity and Milestones
Activity
Months of Projects
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
Searching for hospital for participation of study.
Seeking permission and cooperation from the hospital.
Seek approval from institutional review board (IRB) and Ministry of Health (MOH)
Hiring staff: Team of nurses and training them to be data collector/ Statistician
Data collection
Data analysis
Collating and writing up results
submitting results to MOH for review
Research team meetings and further development/consolidation of project team
6. Ethical considerations.
Ethical consideration is an important component in research studies. It begins at the identification of the research topic and is applied throughout the course of this study. If this study were to be conducted, the rights to self-determination, privacy, anonymity and confidentiality and informed consent will be strictly observed.
To render this study ethical, the researcher needs to obtain permission and sought approval to conduct this study from the university Institutional Review Board (IRB) & the hospital’s ethical committee. Burns and Grove (2011, pg 130) describe IRB as “a committee that reviews research to ensure that the investigator is conducting the research ethically”.
Informed Consent
Burns and Grove (2011, pg 122) define informed consent as the “prospective subject’s agreement to participate in a study as subject after the transmission of essential ideas and content from the investigator to the prospective subject”. The researcher will informed the subjects about the aims and purpose of this study and the methods use to collect the data. Burns and Grove (2011, pg 125), adds that “researchers using questionnaires to collect relatively harmless data do not need to obtain a signed consent form from the subjects. The subject’s completion of the questionnaire may serve as consent”. At the top of questionnaire, the researcher will include a statement such as, “your completion of this questionnaire indicates your consent to participate in this study.”
The Right to self-determination
The rights to self-determination will also be maintained. According to Burns and Grove (2011, pg 110), “the right to self-determination is based on the ethical principle of respect for persons, and it indicates that humans are capable of controlling their own destiny”. The researcher will treat subjects as an autonomous agents by informing them about the study and allowing them to voluntarily choose to participate or to withdraw from the without any penalty (Burns and Grove, 2011). Due to the vulnerability of the subject, due to the medication error done, the researcher will reassure the subjects and will ensure that subjects are not coerced into participating in the research.
Right to Privacy
The researcher will protect the subject’s right to privacy, by informing and securing the subject agreement to participate and voluntarily share private information with the researcher. Private information includes information received during the interview session such as the subject’s attitudes, beliefs, behaviours, opinions and record (Burns and Grove, 2011). The researcher will reassure the subject that any information received will not be shared without the subject’s knowledge or approval.
Rights to Anonymity and Confidentiality
According to Burns and Grove (2011, pg 117), “on the basis of the right to privacy, the research subject has the right to anonymity and the right to assume that the data collected will be kept confidential”. The authors add that “complete anonymity exists when the subject’s identity cannot be linked, even by the researcher, with his or her individual responses”. For this study, anonymity will be strictly observed by not having the subject’s to write their name on the questionnaire and not including the name of the subject on research report.
The ethical consideration of confidentiality will strictly be maintained by the researcher. Burns and Grove (2011, pg 117) define confidentiality as “the researcher’s management of private information shared by a subject or participant”. The researcher will refrain from sharing information without the permission of the subject. Information received and the data collected will be stored in the researcher computer. Data stored in the computer will be protected by software with secret password in order to protect subject’s confidentiality.
7. Reflections of your study
While conducting the study, the subject might withdraw from the study due to various re
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