Study design
The study was conducted in Beirut, the national capital of Lebanon, during January and February 2021, using the SP technique. A research assistant was trained to play the role of a simulated patient, following a well-structured scenario to identify the actual and spontaneous responses of the community pharmacists. The SP is a female pharmacist who works in a community pharmacy as well as a research assistant and has already participated in several simulated patient studies. She was instructed not to proceed with the role-play if her identity was revealed, and to ask for vitamin C effervescent tablets instead. Moreover, if the pharmacist offered to sell a medication to the SP, the counseling behavior was observed by the SP, who would later pretend that she forgot to bring her wallet and act like she was going home to bring it so that she can pay for the medications. She would then thank the pharmacist and leave.
Finally, the SP captured the time of each visit, using a personal stopwatch, and documented each pharmacist’s responses using the data collection form, immediately after leaving the pharmacy to minimize any possible recall bias.
Selection of pharmacies
At the time of the study, there were 235 registered community pharmacies in Beirut [25]. Pharmacies were coded and their list was scrambled, and the first 100 pharmacies were selected as a sample using an online sample size calculator from Raosoft®, assuming that appropriate care for COVID-19 suspects is provided by 50% of the pharmacies, with an accepted margin of error of 7.5% and a confidence interval of 95% [26]. A pharmacy would be replaced by the next one from the remaining pharmacies if the SP’s identity was revealed, or the pharmacy was unreachable or found closed.
The simulated patient scenario
The applied scenario included a 25-year-old female (the SP) who visited the selected pharmacies, adhering to the PPE (wearing a surgical face mask, a face shield, and gloves). She avoided touching surfaces and maintained a safe distance from others in the pharmacy. The SP approached the dispensary, requesting to speak with the pharmacist. The SP, while looking worried about her health, informed the pharmacist that she was experiencing fever and loss of smelling sensation within the past 2 days, and she requested the pharmacist’s health advice with regards to her symptoms, “I’m having fever and loss of smell for the past two days. What should I do?”
The following information was provided only upon the pharmacist’s request. She was unemployed, previously healthy, non-smoker, living with her parents, and was not receiving any chronic medication. She measured her body temperature several times, and it ranged between 38 and 38.5 °C. When asked about the medications utilized to cope with her symptoms, she reported that she took one tablet of Profinal XP® (ibuprofen 400 mg/caffeine 65 mg) 2 h before her visit to manage her fever. She did not have any red flag symptoms such as dyspnea, confusion, chest pain, decreased urine output, hemoptysis, bluish lips, or cold extremities. She visited a friend a week ago, who recently tested positive for COVID-19, and she did not undergo the polymerase chain reaction (PCR) test.
Data collection form development and structure
A standard form was developed after an extensive literature review by the research team [3, 27,28,29,30]. It consisted of five main sections, with 40 different items, varying between close-ended (pre-specified options) and open-ended questions. The first section gathered information about the pharmacy being visited, including the pharmacy code, sex and the estimated age of the encountered pharmacist, the date, time, and duration of the visit.
The second section recorded the questions being asked by the pharmacist to retrieve the patient’s medical history. The third section identified the pharmacist’s response to the patient’s situation. The second and third sections of the data collection form were developed based on the guidance that was issued by the Centers for Disease Control and Prevention (CDC), which guides the healthcare providers to advise suspected COVID-19 patients on seeking appropriate medical care [28]. This guidance includes screening for COVID-19 exposure and symptoms, evaluating life-threatening conditions, assessing high-risk patients, a decision algorithm for appropriate case disposition, and tailored care advice messages.
Finally, the last section assessed the encountered pharmacist’s communication skills using a validated, patient-centered model [29]. This model consisted of several items including nonverbal and verbal communication skills such as eye contact, body posture, active listening, questioning, preparedness and approach, empathy, and closure. Each item was rated on a 4-point scale, ranging from 0 (unsatisfactory performance) to 4 (distinguished performance). Cronbach’s Alpha test was used to assess the internal reliability of the scale, which yielded 0.89, making the scale reliable with good internal consistency.
Additionally, another two experts in pharmacy practice have reviewed the form for face and content validity. An amendment was made based on their recommendations (see Additional File. 1 for the data collection form).
The SP training
The SP was trained by the study principal investigator (PI) to perform the role-play and use the data collection form. Then, several role-plays, for the above-designed scenario, were performed between SP and another study researcher, acting as a community pharmacist. Meanwhile, the PI was observing and assessing the performance of the SP during the role-plays and giving his feedback. Then both the SP and the PI documented the mock pharmacist’s responses, after each role-play, using the data collection form, and compared their findings to ensure consistency of the recorded observations.
The pilot test
The SP visited 10 pharmacies (other than the sample) accompanied by one researcher (acting as a client) to validate the simulation process, assess the scenario’s feasibility, and ensure the reliability and reproducibility of the data collection form. Modifications to the scenario and the form were made accordingly.
Ethical considerations
The World Medical Association Declaration of Helsinki guidance was followed in designing and conducting this study [31]. The protocol was approved by the Institutional Review Board of Beirut Arab University (No. 2020-H-0072-P-M-0438) with a waiver of informed consent for the nature of the study. This waiver did not adversely affect the rights and welfare of the subjects, and all measures to protect their confidentiality were taken. Moreover, the recruited simulated patient (SP) is one of the study authors, so no further ethical parameters were required.
Data analysis
Data were analyzed by the 24th version of the Statistical Package for the Social Science (SPSS®, IBM Corp., Armonk, NY, USA). The descriptive data were represented by frequencies and percentages for categorical variables, and mean with standard deviation for continuous variables.