This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
Tobacco cessation training programs to treat tobacco dependence have measureable effects on patients’ smoking. Tobacco consumption in low- and middle-income countries (LMICs) is high and slowly decreasing, but these countries usually lack measures to face the epidemic, including tobacco cessation training programs for health professionals and organizations. Based on a previous online smoking cessation training program for hospital workers in Spain, the Fruitful Study aims to increase smoking cessation knowledge, attitudes, self-confidence, and performance interventions among health care professionals of three Spanish-speaking low- and middle-income Latin American and Caribbean (LAC) countries.
The purpose of this paper is to describe the methodology and evaluation strategy of the Fruitful Study intended to adapt, implement, and test the effectiveness of an online, evidence-based tobacco cessation training program addressed to health professionals from Bolivia, Guatemala, and Paraguay.
This study will use a mixed-methods design with a pre-post evaluation (quantitative approach) and in-depth interviews and focus groups (qualitative approach). The main outcomes will be (1) participants’ attitudes, knowledge, and behaviors before and after the training; and (2) the level of implementation of tobacco control policies within the hospitals before and after the training.
To date, adaptation of the materials, study enrollment, and training activities have been completed. During the adaptation, the main mismatches were language background and content adaptation. Several aids were developed to enable students’ training enrollment, including access to computers, support from technicians, and reminders to correctly complete the course. Follow-up data collection is in progress. We have enrolled 281 hospital workers. Results are expected at the beginning of 2017 and will be reported in two follow-up papers: one about the formative evaluation and the other about the summative evaluation.
There is a need to learn more about the cultural and content elements that should be modified when an online tobacco cessation training program is adapted to new contexts. Special attention should be given to the personal and material resources that could make the implementation possible. Results from the Fruitful Study may offer a new approach to adapting programs to LMICs in order to offer education solutions with the use of emerging and growing communication technologies.
Clinicaltrials.gov NCT02718872; https://clinicaltrials.gov/ct2/show/NCT02718872 (Archived by WebCite at http://www.webcitation.org/6mjihsgE2)
Tobacco use remains a global public health concern; annually it causes 6 million preventable deaths [
In the LAC region, smoking rates vary by country, sex, and socio-economic status [
In LAC countries smoking consumption among health care professionals is still similar to that of the general population [
Implementation research recommends addressing organizational constraints in order to overcome executive barriers when the cessation messages are delivered such as lack of time, support, and resources [
In the literature, there are several conceptual training models that exhibit significant heterogeneity [
Using previously established programs can save time and money while increasing the likelihood of achieving successful outcomes [
Adaptation implies not only to the replication or translation of a program but to the process of adjusting a program to reduce mismatches between its characteristics and the new context in which it is to be implemented. Adapting a tobacco cessation education program should take into account the treatment regulation of each country, the existing guidance and proceedings, and the dynamics of the health organization [
We selected the ongoing Brief Intervention for Smoking Cessation Training Program from the Catalan Institute of Oncology (ICO) as the baseline program and created a partnership between ICO and three hospitals from Bolivia, Paraguay, and Guatemala to first adapt and later disseminate the course. We intend to increase the capacity-building of the implicated organizations that will ultimately initiate a cascade of change within their countries [
The purpose of this paper is to describe the methodology and evaluation strategy of the Fruitful Study research protocol intended to adapt, implement, and test the effectiveness of an online, evidence-based tobacco cessation training program addressed to health professionals from Bolivia, Guatemala, and Paraguay.
The primary research goal of the Fruitful Study is to evaluate the impact of an online, evidence-based tobacco cessation training program aimed to increase smoking cessation knowledge, attitudes, self-confidence, and performance interventions among health care professionals of three Spanish-speaking low- and middle-income LAC countries (Bolivia, Guatemala, and Paraguay).
Our primary hypothesis is the participants in the online tobacco cessation training program will increase their tobacco-related knowledge, attitudes, and behaviors by the 6-month follow-up, as compared to baseline conditions prior to the training. Our secondary hypothesis is that participating hospitals will exhibit greater tobacco control progression, commitment, and implementation of tobacco cessation services.
The Fruitful Study is a 2-year mixed-method (qualitative and quantitative) study conducted in one hospital in each of the three participant countries (Bolivia, Guatemala, and Paraguay).
For the quantitative approach, a pre-post design will be used to (1) assess participants’ attitudes, knowledge, and behaviors before and after the training using a questionnaire (Tool 1); and (2) measure the level of implementation of tobacco control policies within the participant hospitals before and after the training using the Self-Audit Questionnaire (SAQ) (Tool 2). For the qualitative approach, focus groups and in-depth interviews of key persons will be used. With this methodology we aim to (1) explore the experience of adapting the training program in each of the participant hospitals; (2) ascertain participants’ experience undertaking the training program; and (3) understand the opportunities and barriers of undertaking online smoking cessation training programs in the participant countries. With the results of the focus groups, the research team aims to identify any difficulties in accessing and completing the course and to make the necessary improvements.
The two main participant units from each organization are students and the hospitals themselves. The participant hospitals were selected because they had previously collaborated with the Training Unit of the ICO in training their health professionals in either electronic learning (e-learning) or in-person courses. The selected hospitals and their characteristics are shown in
Characteristics of the selected hospitals.
Hospital | Country | Type of hospital | Workers, n | Beds, n |
Instituto Oncológico del Oriente Boliviano de Santa Cruz de la Sierra | Bolivia | Public, urban oncology hospital | 359 | 79 |
Instituto de Cancerología y Hospital Dr Bernardo del Valle | Guatemala | University, public, urban oncology hospital | 300 | 108 |
Instituto Nacional de Enfermedades Respiratorias y del Ambiente (INERAM) | Paraguay | University, public, respiratory hospital | 746 | 151 |
Student participants were all health professionals and paraprofessional staff from the three participant hospitals. All health providers in the selected hospitals, including nurses, doctors, and other health professionals were invited to enroll in the training. Each local coordinator recruited participants from a variety of units and departments over a 6-month period through informative sessions, leaflets, and posters (designed to inform about the training program).
The selected original training program was chosen because it was shaped using evidence-based guides, was originally designed for Spanish hospitals (culturally and organizationally similar to LAC hospitals), and is addressed to hospital workers. Furthermore, offering the course through an online platform has clear potential to reduce cost and increase training coverage within participant hospitals in less time.
The original course was developed in the online platform e-oncologia based on the in-person courses offered during the last 10 years by the Tobacco Control Unit of the ICO. The theoretical framework underpinning the training program is the Stages of Change Model [
Modules
Module 1 describes the tobacco epidemic, tobacco-related morbidity and mortality, second hand smoke, and measures included in the MPOWER strategy to tackle smoking.
Module 2 provides orientation on how to assess the smoker, how to assess tobacco dependence and willingness to quit, and evaluate smoker self-efficacy, previous quit attempts, previous relapses, and so on.
Module 3 introduces the efficacy of the different levels of attention and treatment orientations (eg, cognitive behavioral, psychodynamic, medication management) and presents the clinical settings where the intervention is possible (eg, inpatient, outpatient, ambulatory treatments). It explains in detail the 5As intervention model.
Module 4 explains in detail the different tobacco cessation treatments available (nicotine replacement, bupropion, varenicline, and other treatments). It also provides orientation about the follow-up, strategies to improve the adherence of the treatment, how to identify withdrawal symptoms, how to deal with relapses, and so on.
This online training program includes (1) slides; (2) review exercises; (3) cases of 4 patients differing in demographics, diagnostic, stages of change, setting; and (4) problem solving exercises. The training provides several materials including slides, online tutorials with an expert tutor, recommended readings, patient cessation brochures, a therapeutic pocket guideline, and an organizational recommendation model to facilitate the implementation of tobacco cessation services in the hospital setting.
The original online course was firstly tested by 10 voluntary participants in Catalonia (Spain). Evaluation of the tobacco cessation program was thereafter tested in the ICO by 150 health professionals. This pilot test proved the acceptability of the training model, the adequacy of its contents, and obtained a high level of satisfaction in the trainees. This training initiative has also been shown to increase the level of implementation of tobacco control in Catalan hospitals (according to the SAQ) [
Based on literature regarding attrition among online learners [
Conceptual framework.
Program model.
The adaptation has been done with local partners and other stakeholders. First, a group of professionals with extensive experience in tobacco control in their country were selected for identifying and categorizing mismatches between the original materials and the new context. Experts expressed that the goal and objectives were aligned with the original program model (
Mismatches
Language background and literacy level in some of the terms used:
The course was in Spanish from Spain, and the Spanish spoken in Bolivia, Guatemala, and Paraguay differs somewhat with respect to vocabulary, some expressions, and in some cases even in grammar structures.
Description of the epidemiology smoking in Model 1:
The original version included the situation in Spain, whereas the adapted version included the most updated data in Bolivia, Guatemala, and Paraguay.
Tobacco cessation pharmacological treatment in Module 4 (nicotine replacement therapy, bupropion, varenicline) and settings where tobacco prevention and cessation services are performed in Spain (primary care, hospitals, quitlines, etc) were adapted to the current resources in each country.
In case studies, the clinical simulations demonstrate the cultural characteristics of each country.
Questions and answers of the assessment and evaluation were also changed according to the adapted contents.
Several aids were necessary in order to enroll students. Thus, local investigators suggested a double registration method through the online platform consisting of an independent method (first one) by which students generated their own credentials and a second one assisted by a computer technician who created the login credentials and helped them in the usage of platform. The second method was necessary since many students had little or no experience in pursuing online education.
This study is expected to last 24 months (from November 2014 to November 2016). Information on the various activities is depicted in the event planning timeline (
This paper was written during the 18th month of the study when the post-evaluation data was being gathered. During the training (months 6 to 13), each participant had 1 month to fill in the baseline evaluation, complete the online training, and take the exam. Participants were monitored by local coordinators that acted as champions and encouraged participants to enroll and complete the course. Coordinators set monthly meetings with personnel from the different units and services to increase the number of participants and support those enrolled to complete the course. In addition, during the implementation, coordinators from each hospital offered assistance to students with little or no computer skills. Technical support was mainly used by less educated health professionals (assistants and support health professionals) and older workers who were less familiar with the use of computers. They offered their assistance in logging into the online platform, filling out the questionnaires, completing the evaluation, as well as other technical support-related issues. Participants’ progress was monitored in real-time on the Web platform. The project coordinator at the ICO sent biweekly reports of the participants' progress to coordinators, and if necessary personal emails and videos that motivated the students to finish the course and complete the evaluations. Participants accessed the course using their electronic devices (mobile phones, tablets or computers) or the ones provided by their hospitals during and after working shifts. The hospitals from Guatemala and Paraguay made a library available with computers to facilitate students’ enrolment before or after their working hours. The hospital from Bolivia provided a computer room in which students had access to the course and the support of a technician during specific hours of the day. Therefore, the participating hospitals facilitated computer and Internet access at the workplace.
Event planning timeline.
To design the evaluation we applied the conceptual frame for continuing medical education (CME) conceived by Moore et al [
The formative evaluation will assess the adoption, implementation, and maintenance of the training program. We will measure program coverage, completion rates, fidelity with the training program, usage of the materials, and the satisfaction with the training. We will use qualitative (focus groups and interviews) and quantitative methods to gather this information. The indicators linked to the performance of the program are (2) number of participants; (2) characteristics of the participants (profession, units, sex, age); (3) number of hours dedicated to the training program; (4) program performance and fidelity to the curriculum plan (whether the students completed all the modules, the exercises as planned); (5) service utilization or dosage use of the training (time applied for undertaking the course, number of downloads of the materials, etc); and (6) opinions, experience, perceptions, and satisfaction with the training course.
We will investigate the short and intermediate outcomes by measuring the impact of the smoking cessation training program within the participant hospitals using quantitative methods (pre-post design). This will include the level of implementation of tobacco control policies within the participant hospitals before and after the training by using the SAQ (Q1) and participants’ attitudes, knowledge, and behaviors before and after the training using a questionnaire (Q2).
To assess differences in tobacco control polices implemented within the hospitals we will use the European Network of Smoke free Hospitals (ENSH) SAQ [
Trainers’ attitudes, knowledge, and behaviors will be assessed using a questionnaire composed of 63-items. The website-delivered questionnaire is emailed to the participants at baseline and 3 months after finishing the training. The questionnaire, designed by Sheffer et al [
Each participant country will carry out at least 5 focus groups with hospital workers enrolled and not enrolled in the course. Participants will be volunteers. The focus groups will consist of homogenous working categories to avoid possible reticence of some participants to openly talk in the presence of their supervisors. In each country focus groups will be conducted by external local qualitative researchers that will follow the same protocol.
Descriptive statistics will be used for the quantitative indicators. The quantitative variables will be summarized using means and other central tendency measurements, whereas the qualitative data will be summarized by computing their frequencies and percentages. The qualitative indicators gathered by the qualitative methods (focus groups and interviews) will be summarized using the classical content analysis approach (creating codes and chunks of information and the researcher complements the codes with description of this code). Analysis of the data will be validated by informants to increase the reliability of the data [
Usual statistics will be used to describe the sample and non-parametric tests will be used for pre-post comparisons for tobacco control policies (measured by Tool 1) and the trainees’ knowledge, attitudes, and behaviors (measured by the Tool 2). In addition, a validity and reliability test of both instruments is planned.
Based on literature regarding gains of training [
We have enrolled 281 hospital workers (105 from Bolivia, 88 from Guatemala, and 88 from Paraguay). The overall average completion rate is 66.2% (186/281). At the time of submission of this paper, data collection for the post-evaluation was underway. Evaluations will finish in November 2016 and results are expected by the beginning of 2017. Results of this study will be reported in two follow-up papers: one about the formative evaluation and the other about the summative evaluation.
We will consider a good level of coverage of the training program if at least 50% of the enrolled health professionals in each hospital conclude the training program. We will measure the engagement of the training program with the focus groups and key informant interviews. We anticipate that hospitals will increase their tobacco control policies by 20% to 30% according to the SAQ. In addition, we anticipate that health professionals’ level of knowledge, attitudes, and perception in tobacco cessation will increase to 30% to 40%.
Health professionals and paraprofessional staff from the three countries will be invited to voluntarily participate in the project. We will be able to determine whether the recruitment process used by each coordinator affects both the number of participants recruited and the commitment to start and finish on time. We hypothesize that as they agree to join, they will be highly motivated to pursue the course and we expect many of them to succeed on their own. However, participants may have varying levels of computer skills and Internet usage that could affect their course enrollment and progression. Online training programs also require devices for their use (ie, computers, tablets or mobile phones with app capabilities) and a high speed Internet connection. Although Internet services and technological devices are rapidly growing in low-income countries [
According to a paper by Ng et al [
It is for these reasons that the methods and results of Fruitful Study may offer a new approach to adapt and implement programs to LMICs countries in order to offer education solutions through the use of emerging and growing communication technologies.
It is critical to develop distant learning programs to train health workers in tobacco cessation in LMIC where opportunities for continuing education are scant and sometimes not well adapted to the reality of their contexts. This study will show whether it is possible to adapt and implement an online course in developing countries. In addition, we will determine how best to implement effective distant-learning strategies in organizations belonging to LMIC, especially to detect what resources and aids are required to make the training possible in all levels of the workforce. Finally, we will measure whether the training program will increase knowledge, attitudes, and perception in tobacco cessation among participants and will produce changes in tobacco control policies at the organizational level.
European Network of Smoke free Hospitals
Catalan Institute of Oncology
high-income country
Latin American and Caribbean
low- and middle-income country
Self-Audit Questionnaire
World Health Organization
WHO Framework Convention on Tobacco Control
We would like to thank the Group of Hospital Coordinators in the Fruitful Project: Liz Soraya Pérez, Julio Poiqui, Maria del Camen Guzman, Noelia Cañete, Eduardo Gharzouzi, Joaquin Barnoya, Wendy Yantuche, and Victor Samayoa, for their assistance in the implementation of this training project. We also thank Cris Rajo for her help during the design process of this research protocol.
This study has been funded by Global Bridges Mayo Clinic (Pfizer Medical Group; GB-13520139: Development and Dissemination of a Tobacco Cessation Training Program for Healthcare Professionals in Spanish-speaking Countries). Moreover, CM and EF are also funded by the Spanish Government (Instituto de Salut Carlos III, grant PI15-00875) and the Catalan Government (Xarxa Catalana d’Hospitals sense fum, Agència de Salut Pública de Catalunya, contracte Nº 2015VAR171)
CMM and EF conceived the project. CMM coordinated the contents of the program. EF and AC co-designed the study, oversee the training content, and supervise the day to day activities. OG and MM manage the technical support with the online platform. MAA, CS, and PC are the project leaders in their hospitals and are responsible for advancing the project activities as scheduled.
None declared.