Research design and setting
An intervention research design was conducted/ A quasi-experimental research study with two groups (nurses and patients), pre-test post-test design was conducted.
This is an intervention study was conducted at Alexandria's new medical center; is an Egypt-based public shareholding organization engaged in the provision of medical diagnostic and treatment services in various medical fields has the capacity of 300 beds and provides a range of medical services, including dialysis, oncology, blood diseases, gynecology, general surgery, pediatrics, internal disease, laboratory and radiology, ophthalmology, ear, and throat disease, outpatient clinics of various specialties, natural treatment unit, radiotherapy unit, intensive-care unit, and dental and oral surgery, among others.
Study participants and sampling
The subject of the study comprised all nurses (N = 60) working at dialysis, oncology, and blood diseases units, who are dealing with medications daily and willing to participate in the study. The sample size was calculated using the “Epi info program version 7” and indicated the minimal sample size to be (52) nurses. The sample size was based on a variance of 5%, a confidence level of 95%, and a power of 0.80. Fifty-five nurses participated in the study (response rate = 91.7 %). This response rate was expected as the medication safety educational sessions were developed based on their identified needs and the hospital administrator’s invitation to conduct the training. By using the proportional allocation method, 25% of the total number of patients hospitalized during the time of data collection and who have long-term medications with regular admission to long terms care units were selected randomly 35 patients had been invited to interview; who were willing to participate in the study.
Study instruments and technique
Nurses' five moments for medication safety tool: A structured questionnaire; was developed by the researchers based on the World Health Organization’s five moments for medication safety tool (WHO, 2019). It is a self -administered questionnaire that consists of two main sections:
Section 1: includes questions about nurses’ demographic and work variables.
Section 2: includes 25 questions categorized under five main stages; each stage includes five questions, which assess nurses’ promotion of patient engagement by introducing five moments for medication safety to their patients, and their families. Responses were measured on a five-point Likert scale ranging from 1–5 (1 never, 5 always). Higher scores indicated a higher level of nurses’ application of the World Healthcare Organization’s five moments for a medication safety tool
Patient' five moments for medication safety tool: Face- to -face structured interview with patients was developed by the researchers based on the World Health Organization’s five moments for medication safety tool (WHO, 2019), to assess patient engagement has been developed as a part of the third WHO Global Patient Safety Challenge: Medication without Harm. It is intended to engage patients in their care in a more active way, to encourage their curiosity about the medications they are taking, and to empower them to communicate openly with their health professionals. This tool includes two sections.
Section one: includes questions about patients’ demographic data.
Section two: includes 25 questions categorized under five main stages (Starting a medication, taking medication, adding medication, reviewing medication, and stopping the medication). Where each stage includes five questions. Responses on tool two were measured using a three-point Likert scale yes (3), sometimes (2), no (1). Higher scores indicated a higher level of patients’ application of the World healthcare organization's Five moments for medication safety tool.
Validity and reliability of the study tools
The two tools were created in English and then translated into Arabic to fit the Egyptian culture and nurses' and patients' various educational levels. The questionnaire was handed to a panel of five academic expert members to determine the face validity and fluency of the translation. Some items were changed to make them clearer, based on their suggestions. A language expert re-translated the tools into English. To ensure accuracy and reduce any threats to the study's validity, the authors and specialists checked the re-translation. Pilot research was done on 5% of nurses (n = 5) also carried out with nurses from different units to check and ensure clarity and applicability of the tools; identify obstacles and problems that may be encountered during data collection with no change occurring. The interview guide was sent to research peers to check and establish its face validity with a result of all agreeing on the interview guide. A pilot interview was conducted utilizing the developed guide to pretest the questions before data collection, support refinement of the questions as needed, and assess the researcher’s competency with the interview technique which was followed by data collection. As a result, the final tool was received a few weeks. The tools were also assessed for internal reliability, and the results indicated that the tool was trustworthy, with a Cronbach's coefficient alpha of 0.979 for the questionnaire and 0.957 for the interview sheet.
After obtaining the approval of the ethics committee of Alexandria's new medical center, the researchers explained the aim of the research to all participants. The study was implemented in five stages: World healthcare organization’s Five moments for medication safety content development, pre-test, intervention application, post-test, and data analysis.
In the first stage, the content of the World Health Organization’s Five Moments for Medication Safety Tool was developed based on patients' and nurses’ needs assessment and the Global Patient Safety Challenge on Medication Safety. Educational sessions of the World Health Organization’s Five Moments for Medication Safety Tool that aimed to raise nurses' and patients’ awareness on medication safety and towards medication without harm. The educational sessions covered the following topics: self-assessment (strengths and weaknesses), connecting self-understanding with the third challenge of the World Health Organization’s Five Moments for Medication Safety Tool, factors increased occurrence of medication errors and how to prevent it, five main stages of medication safety (Starting a medication, taking medication, adding medication, reviewing medication, and stopping the medication), application of five moments for medication safety.
In the second stage, the pre-test was performed before the beginning of the sessions using the study tools. The researchers described the purpose of the study to all participants after receiving approval from the hospital. The first tool was the Arabic form, which was hand-delivered by the authors to the nurses who participated in the study and were given specific instructions on how to complete the questionnaire. In this stage, the questionnaire was provided to the participants for one day to complete. After that, the researchers went to the units to collect the completed questionnaires, which were often left with the unit nurse’s manager.
In the nursing unit office or patients’ rooms, face-to-face structured interviews were conducted with patients in the Arabic language before intervention. At the start of each interview, the researcher explained the nature of the study, the associated ethical considerations, the estimated duration of the interview, data confidentiality, and voluntary participation, and obtained the patient's consent to participate in the study and to be quoted along with information. Because of the delicate nature of the subject, participants were given anonymity and the freedom to withdraw from the study at any time.
Based on the results of the assessment, the third stage, educational sessions of the World Health Organization’s Five Moments for Medication Safety Tool were provided to nurses and patients. The nurses were divided into 5 groups, each group included 10-11 nurses while patients were divided into 3 groups according to their hospitalized units, each group included 11-12 patients. Each group was provided with three awareness sessions to cover the content. Each session took approximately two hours. A total of 15 sessions for nurses and 9 sessions for patients were conducted to cover all participants groups. The educational sessions were designed to satisfy the nurses' and the patients' needs. The training classes were implemented for nurses and patients at the studied hospital by the researchers. Following those, classes were implemented for patients by the trained nurses under the supervision of researchers. The following teaching methods were utilized: interactive lecture, discussion, brainstorming, and role play. The Media of teaching involved PowerPoint slides, flip charts, handouts, the booklet, pamphlet, flyer, poster, and mobile application (loaded onto a researcher’s smartphone).
In the fourth stage, a post-test was done by using the study tools (Nurses five moments for medication safety, and Patient' five moments for medication safety tools) that were used in the second stage, to reveal the change in nurses, and patients' outcomes concerning medication safety after giving the five moments for medication safety intervention and to determine how the educational sessions were aligned with the specific concepts and measures employed in the study. In addition, the developed evaluation form was used to evaluate the educational sessions of the World Health Organization’s Five Moments for Medication Safety Tool at the end of sessions from nurses' and patients’ perspectives. Finally, the fifth stage; data analysis was conducted.
Written approval was obtained from the administrators of the identified setting to collect the necessary data. Data were collected by the researcher using the study questionnaires, which were distributed individually to participants before and after educational sessions. Each nurse took approximately 20 minutes to complete all questionnaires and the length of the interview with patients ranged from 30–45 minutes. Educational sessions and data collection were coordinated with the nursing education department and health education department in the hospital to organize educational sessions according to workplace policy. Data were collected in 3 months, from September to November 2021.
Data analysis and management
Data were collected, tabulated, and analyzed statistically using an IBM personal computer with Statistical Package of Social Science (SPSS) version 25. Qualitative data were described using numbers and percentages. Kolmogorov-Smirnov test was used to verify the normality of distribution Quantitative data were described using mean, standard deviation. The following statistics were applied. 1. Descriptive statistics: in the form of mean percent score with standard deviation; qualitative data were presented in frequencies and percentages. 2. Analytical statistics: Wilcoxon signed ranks test used for abnormally distributed quantitative variables, to compare between two periods, Paired t-test for normally distributed quantitative variables, to compare between two periods and Correlation coefficients are used to measure the strength of the relationship between two variables. Multiple linear regression was done using the "Enter" method, to predict the dependent outcome from independent predictors by Pearson correlation. The unstandardized regression coefficient (beta) for each independent predictor was compared to the beta of the standardized coefficient, to determine the strength of each as an independent predictor, even after adjusting the effect of other predictors in the model. All statistical analysis was done using two-tailed tests and an alpha error of 0.05. Regarding P-value, it was considered that: non-significant (NS) if P> 0.05, Significant (S) if P< 0.05, Highly Significant (HS) if P<0.01.