Evaluation of an intensive education program on the treatment of tobacco-use disorder for pharmacists: a study protocol for a randomized controlled trial

The aim of this randomized controlled study is to design, implement, and evaluate an intensive education program provided by team of health professional educators on tobacco-use treatment for pharmacists in Qatar.

The primary objectives of the study are to assess the effectiveness of the program on pharmacists’ knowledge and skills in relation to tobacco and tobacco cessation assessed using a multiple-choice-based evaluation instrument and an Objective Structured Clinical Examination (OSCE), respectively. The secondary objectives are to assess the effectiveness of the program on pharmacists’ attitudes toward tobacco cessation and perceived self-efficacy (i.e.. confidence) in tobacco-cessation interventions, assessed using a survey instrument, and to assess the effectiveness of the program on pharmacists’ tobacco-cessation skills in the practice setting, assessed using the simulated client approach.

The study is a prospective randomized controlled trial comparing the effectiveness of the education program, versus non-tobacco-related training, on pharmacists’ tobacco-related knowledge, attitudes, self-efficacy, and skills. The study methodology and procedures are shown in Fig. 1. The protocol is developed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials guidelines (SPIRIT; Fig. 2 and Additional file 1).

The evaluation of the effectiveness of the program will be conducted using multiple strategies as follows:

All community pharmacists practicing in Qatar are eligible for participation in the study. There are no specific exclusion criteria for participants’ enrollment in the study.

Information about the study and its purpose were made available to the Ministry of Public Health, which subsequently made available a database that has contact details of all community pharmacists practicing in the country (around 1000 pharmacists). A stratified random sample of 200 pharmacists was obtained from the list. Stratification was done by pharmacy so that no more than one pharmacist from each pharmacy would participate. Invitations to participate in the study will be made by the study research assistants (RAs) over the phone or in writing. Those who express interest will be sent a Participant Information Sheet (PIS) and a consent form. Consenting participants will be randomly allocated to intervention or control groups using permuted block randomization with blocks of size 2, 4, and 6. Randomization will be made by the study statistician who is not involved in the recruitment of the pharmacist and will be concealed for the RAs recruiting the pharmacists. Blinding of study participants in relation to their allocation to the study groups will not be possible given the nature of the intervention.

The study has two primary outcomes: post-intervention tobacco-related knowledge and post-intervention skills for tobacco cessation assessed using a multiple-choice-based evaluation instrument and an OSCE, respectively. The secondary study outcomes are post-intervention attitudes towards tobacco cessation and self-efficacy in tobacco-cessation interventions assessed using a survey instrument. An additional secondary study outcome is the post-intervention performance difference in relation to tobacco-cessation skills in the practice setting assessed using the simulated client approach.

In this phase, the study will evaluate whether participants in the intervention and control groups will offer appropriate tobacco-cessation counseling and will recommend proper tobacco-cessation aids in their practice setting. Using a simulated client approach to data collection 3 to 6 months post training program, the study will assess the appropriateness of advice and recommendations given to a simulated client who asks for assistance in quitting smoking. The simulated client method is recognized and used internationally for assessing the quality of services offered by pharmacists including smoking cessation [29‐32]. Simulated clients using two designed and validated case scenarios will visit participants in both groups. The clients will be selected to resemble the sociodemographic and practice characteristics of the Qatar population and its residents. Objective assessment forms will be developed using tobacco-cessation guidelines including the U.S. Department of Health and Human Service clinical practice guidelines (CPGs) for treating tobacco use and dependence and the Qatar guidelines for management of tobacco dependence as guides [5, 33]. Individual items in assessment forms will be completed using dichotomous scales (closed-ended yes/no questions) and will target different aspects of pharmacist performance including gathering information and patient history-taking, assessing the patient, recommending an appropriate treatment plan, and providing counseling. Research assistants will accompany the simulated clients in their visits. They will complete the assessment forms and will record the notes summarizing the encounter. One-to-one training will be provided to simulated clients and RAs by the study research team. Training will offer opportunities for the shoppers to role-play and to become proficient in their assigned scenarios, will help in refining the assessment sheets, in standardizing the process for all participants and in decreasing inter-rater variability. Both simulated clients and RAs will be blinded for the pharmacist group allocation. Each simulated client will enter the community pharmacy and will ask to speak to the pharmacist. The client will start with designed queries as per an assigned scenario. The pharmacist will then be given the chance to offer the counseling. After the visit is completed, an explanation of the purpose of the visit and how the collected data will be de-identified will be shared with the pharmacists. Anonymity and confidentiality will be ensured. Consent to participate in this phase of the study will be sought at this time. For pharmacists who decline to participate, information collected during the patient encounter will be discarded.

Data will be analyzed using IBM SPSS (IBM SPSS® for Windows, Version 24.0; IBM Corp, Armonk, NY, USA). The Consolidated Standards of Reporting Trials (CONSORT) guidelines will be followed when analyzing the study data [34]. Demographic and other pharmacist education and practice-related questions, along with baseline knowledge, attitudes, and perceived self-efficacy, will be summarized using means and standard deviations for numeric variables such as age and year of experience and frequency distribution for categorical variables such as gender, country of education, etc. Those will be compared between the study groups so that differences will be used to adjust the primary analyses.

The primary analyses will include comparing post-knowledge scores between the two study arms using the independent t test and the skills-related scores on the OSCE using the same method. The secondary analyses will include adjusting the main analyses to any imbalances in baseline variables that are observed between the study arms. This will be done using the linear regression method. Moreover, knowledge scores will be compared within each study group using the paired t test. For outcomes that are dichotomous or that will be dichotomized, such as the percentage of pharmacists with a specific attitude or self-perceived efficacy, then the chi-squared test will be used to compare such outcomes between study groups and the McNemar test will be used to compare responses within each study group over time. Performance on the simulated patient will be compared in a similar manner as the outcomes above depending on whether it is dichotomized or not. In addition, repeated-measures analysis (depending on the scale of measurement for each outcome) may be used to detect whether there is an intervention × time interaction so that difference between study groups is changing over time or not. The level of statistical significance will be set at 5%.

The study protocol and all related instruments and forms were granted ethical approval by the Qatar University (QU) Institutional Review Board (IRB) (QU-IRB 906-E/18). All data related to the study will be kept confidential and will be retained in a password-protected database maintained along with all related study documentation in a locked cabinet at QU College of Pharmacy. Participation in the study will not cause any harm to participants and, as a result, no data monitoring committee will be assigned. Only the study team will have access to the final study dataset. Any protocol modifications will be communicated with QU IRB. The study results will be presented via poster or oral presentations in international conferences and will be published in peer-reviewed journals. The authors of the final study manuscript will have considerable contributions to the design, implementation, assessment, and reporting of the study.

The study progress will be monitored closely by the study team. Meetings will be held to guide the study towards its aim and objectives with team involvement. A weekly meeting involving all the team members including RAs will be organized. The study team will be in direct touch with each other and RAs through electronic communication (Google® docs and emails). Electronic communication will help in keeping the minutes of the meetings, will provide easy access to any study-related document, and will facilitate online sharing of information. The study team will also conduct ad-hoc meetings at least biweekly to monitor data collection, to check protocol adherence, to review appropriate documentation and to address any issues that might arise.