Development of a qualitative exploratory case study research method ...

Pharm World Sci (2010) 32:36–42 DOI 10.1007/s11096-009-9337-5

RESEARCH ARTICLE

Development of a qualitative exploratory case study research method to explore sustained delivery of cognitive services Susanne Kaae • Birthe Søndergaard • Lotte Stig Haugbølle • Janine Morgall Traulsen

Received: 27 February 2009 / Accepted: 24 September 2009 / Published online: 13 October 2009 Springer Science+Business Media B.V. 2009

Abstract Objective To develop, apply and evaluate a new research method to establish relationships between structural and process elements of the provision of cognitive services. In-depth knowledge about how local organisational structural elements of community pharmacies shape the implementation process of cognitive services is needed to develop targeted quality assurance systems to ensure that the services are continuously provided to the patients who need them. The first publicly reimbursed cognitive service in Denmark, the Inhaler Technique Assessment Service (ITAS) is used as the case. Setting The research method was developed at the Faculty of Pharmaceutical Sciences at the University of Copenhagen and later applied to seven community pharmacies geographically spread around Denmark. Methods A pilot study as well as a subsequent literature review was conducted to determine which structure–process elements to focus on in the research method as well as to select appropriate theories and methods. Results The developed research method was a qualitative exploratory multi-case study, that was based on method triangulation of field observations, semi-structured interviews, group interviews as well as collection of documentary material. The

three main themes of the research method were: the administration of tasks, leadership style and professional values. We integrated the organisational theories of Mintzberg, Bolman and Deal as well as Sørensen to support and clarify the data collection process and analyses. A cross-case analysis and an exploratory contextual analysis relating the leadership style of the pharmacy owner to the ITAS provision were applied to the collected data. Conclusion The developed qualitative exploratory multi-case study research method was satisfactory with regard to achieving nuanced and in-depth results of some relationships between structural and process elements of provision of cognitive services. The research method can be considered an important supplement to the existing literature on the sustainability of cognitive services. Keywords Cognitive services Community pharmacy Denmark Implementation Methodology Organisational theory Quality assurance Structure–process relationships Triangulation

Impact of findings on practice S. Kaae (&) Institute of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark e-mail: [email protected]

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B. Søndergaard L. S. Haugbølle J. M. Traulsen Institute of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, University of Copenhagen, Copenhagen, Denmark

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The new research method is described here obtains nuanced, in-depth qualitative data that reflects to a high degree pharmacy practice as it unfolds in real life. The findings of the described method can more easily be transferred back to, and integrated into practice. The method described is suitable for developing evidence-based quality indicators to monitor the sustainability of cognitive services in community pharmacy.

Pharm World Sci (2010) 32:36–42

Introduction It is becoming increasingly common practice to provide contracts for third-party reimbursed cognitive services in community pharmacies [1–4]. Targeted quality assurance systems would be a valuable support for sustaining the delivery of third-party paid cognitive services to ensure that they are continuously provided to the patients who need them. It is widely recognised that quality assurance systems enable permanent monitoring and evaluation of the way healthcare staff and healthcare sites operate to meet the needs of patients [5]. Quality indicators for the specific service must be developed as part of building a quality assurance system. Basing indicators on scientific evidence by establishing relationships between structure, process and outcome dimensions of the care is recommended [5, 6]. In Denmark, the first publicly reimbursed cognitive service, the so-called Inhaler Technique Assessment Service (ITAS), was introduced in community pharmacies in 2005 [4]. The development of the service on a national level is well documented in terms of the numbers of services provided and in terms of quality, with quality defined as how closely pharmacy staff complies with the mandatory manual when providing the service. The two forms of documentation that exist are (1) two pseudo customer investigations undertaken by the Danish Pharmaceutical Association to register the quality of the service [7], and (2) reports of the number of provided services submitted by Danish pharmacies to the Danish Medicines Agency every month to qualify for reimbursement. However, these data do not provide sufficient material for developing quality indicators, since although the data may reveal characteristics of current ITAS practice, they do not explore the relationships between structure, process and outcome of the service. International studies based on quantitative methods have touched on the relationship between the structure and process of providing cognitive services when trying to explain how organisational factors inhibit or facilitate provision of care [8–10]. Conclusions are often drawn across a span of pharmacies or pharmacists, pointing out similarities or differences in resources, staff competencies, values and perceptions, and organisational attributes. The local context of the service is therefore not related to the local provision, and direct links between structure and process cannot be identified. Other studies have taken a qualitative approach, focusing on the process of implementation to study organisational reasons for the success or failure of implementing cognitive services [11–16]. Usually, interviews are used as the data collection method and ‘content analysis’ as the analytic strategy. Results of this type of research describe elements with regard to relationships between structure and

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process of provision of cognitive services, though they do not explicitly do so, as they do not take the local organisational context of the provided services into account. A few studies explore one particular component of the pharmacy structure: leadership style in relation to provision of cognitive services [17, 18]. Results are gained through the application of questionnaires. The results indicate that there is a connection between the pharmacy leader’s proactiveness and orientation of innovation and provision of cognitive services [17]. One study uses a combination of surveys and personal interviews to develop an in-depth understanding of factors affecting a pharmacy’s ability to support practice change in six pharmacies [19]. The analysis is based on a cross-case analysis using 14 predefined criteria. With regard to factors influencing the reported change in practice, a ranking system was set up to detect significant factor differences between pharmacies with change and pharmacies with no change. Most of the factors identified were associated with improving resources, upgrading staff competencies, regular environmental scanning and interaction with advocates for practice change. The study revealed how some structural elements of community pharmacies are related to pharmacy change including the provision of cognitive services [19]. It can thus be concluded that so far no in-depth relationships between a range of structuring organisational elements in community pharmacies and the sustainable delivery of cognitive services have been established in the literature. We believe that a new type of research method is required to achieve this knowledge to develop quality indicators for ensuring sustainable delivery of the cognitive services. The objective of this article is thus to introduce and evaluate a newly developed and applied research method to explore in-depth relationships between the pharmacies as the local organisational context of cognitive services and the process of implementation.

Methods The process of creating a new type of research method to explore structure–process relationships of cognitive service provision was directed by a pilot study and by a literature review to define the thematic focus of the study and to select theories and methods. Pilot study The pilot study was conducted using field observations in one pharmacy and individual interviews with the pharmacy owner and two pharmacy technicians.

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The study was inspired by theories of medicine technology assessment [20], a Danish implementation study [12] and the results of a test of the ITAS manual before launch [21]. Observations and interview guides were developed to detect some of the themes of the included literature, but the design was otherwise open to catch any obstacles to implementation that the pilot pharmacy staff might reveal. The pilot was based on the principle of bottom-up research for studying in-depth relationships between the structure and process dimensions of implementing cognitive services, since it has been argued that bottom-up perspectives are relevant for developing efficient steering tools for implementing politically instigated initiatives such as publicly reimbursed cognitive services [22]. Bottom-up perspectives are based on the idea that organisations consist of individuals who do not necessarily act rationally and in accordance with what their superiors tell them to do. Motivated by their own perspectives, individuals play an active role in forming local implementation processes. These perspectives may well differ from those of a top-level political player who wants a certain change of practice implemented [22]. The local site of implementation must therefore be the research focus of a bottom-up-inspired study. Key actors must be mapped out to explore their perceptions on the new technology and to further understand how their perceptions help structure the action patterns of the individuals in the organisation. Bottom-up approaches thereby create nuanced knowledge about obstacles to any type of implementation process [22]. Literature review Based on the results of the pilot study the research team decided to rely also on existing literature on implementing cognitive services in pharmacies to direct the identification of which structure-process dimensions of the ITAS to study in detail. Literature by Roberts et al. [23] and Hopp et al. [12] as well as results from the pilot study were found to be relevant. Additionally, a new literature review was undertaken by the research team. The study focused on clearly defined cognitive services like the ITAS. The final review consisted of 12 articles and reports, all dealing with the provision of specified cognitive services where implementation was analysed in relation to organisational elements of pharmacies [17, 24–34]. The included studies were analysed in order to select relevant organisational focus points for the main study. Theoretical framework and methods According to Donabedian [6], knowledge of links between structure and process proceeds from organisational science.

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Organisational theory was thus selected according to the results of the literature review to support and clarify the process of data collection and interpretation. The research team discussed the methods of the pilot study with regard to collecting data on the specified themes and theories. Guides of observations, semi-structured interviews, group interviews and the collection of documentary material were developed subsequently. We found triangulation of data sources and methods necessary both when collecting and analysing data in order to address the relatively wide range of themes in our study (breadth) and at the same time to be able to grasp as much as possible of the complexity of the nature of the chosen themes (depth). Flick advocates that ‘‘the combination of multiple methods, empirical materials, perspectives and observers in a single study is best understood as a strategy that adds rigor, breadth and depth to any investigation’’ [35]. Selection of participants Sampling is an important stage in any research project, as it defines which phenomena are to be explored and determines degrees of generalisability/transferability [35]. One objective of this case study was to include pharmacies other than the early adopters of cognitive services, so we set a purposive sampling frame. Yin recommends the sampling strategy of replicate logic, meaning that study cases are selected on the basis of pre-defined conditions of the case. How these conditions influence the phenomenon under study can be tested when the cases are selected with a stringent variation in conditions [36]. As the conditions of our study (the organisational focus points) could not be determined beforehand to allow a sampling of replicate logic, it became necessary to take a more exploratory approach. Thus we purposively selected pharmacies according to their overall ITAS performance (sustained versus non-sustained provision), but we did so without having a pre-defined hypothesis of how the selected theoretical focus points specifically drove it. Non-sustained providers were defined as pharmacies that experienced a decline in ITAS provision in 2007 compared to their level of provision in 2005 and 2006 (which was the general trend for Danish pharmacies) and sustained providers as pharmacies which had not experienced a decline in services from 2006 and onwards.

Results A qualitative exploratory multi-case study research method was developed according to the results of the described pre-stages and subsequently applied to seven pharmacies geographically spread around Denmark.


Results of the pilot study Results of the pilot showed that a bottom-up approach was appropriate to disclose relationships between structural and process elements of the delivery of cognitive services. One example was that the way in which pharmacy staff proposed and undertook the ITAS reflected their normal practice when dealing with pharmacy patients. However we also found that multiple organisational factors exert influence on the implementation process of the ITAS and that no one theory could be applied to cover all the relevant aspects of sustainable delivery. This conclusion indicated that a multifaceted research method should be applied for the main study. Results of the literature review Three major themes emerged from the selected literature as relevant focus points for the main study: • • •

Leadership style Professional values Coordination and administration of tasks

The themes were found adequate for exploring both the structure (daily life in Danish pharmacies) and the process (implementation of the ITAS). In order to establish relationships between local organisational characteristics of pharmacies with provision of the ITAS, the aims of data collection process were specified as follows: •

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Investigating the basic organisation of the pharmacy with regard to the administration of daily tasks, leadership style and professional values, and how these elements influence each other. Studying the direct involvement of the pharmacy owner in the implementation process of the ITAS. Investigating professional values of pharmacy staff and owner with regard to ITAS provision. Reconstructing the activities being used in the process of implementing the ITAS since the start of the service in 2005.

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The works of Sørensen were introduced to interpret the professional values of the pharmacy owners and staff regarding daily practice in general and the ITAS in particular [38, 39]. Sørensen describes what pharmacy staff themselves perceive as pharmaceutical care at the counter, identifying four different roles of the pharmacist. The categorisation provides a pragmatic analytical tool for distinguishing between different types of professional practice, which was applied to both pharmacy staff and owners. For the purpose of our project, the model was extended to include a fifth category, which is characterised by the pharmacy staff seeing themselves as medicine distributors. We used the organisational theory of Mintzberg [40] on how to design effective organisations to explore how pharmacies try to integrate the ITAS into their daily practice. Mintzberg showed how organisations divide and coordinate work, introducing a set of coordinating mechanisms that organisations use to ensure the quality of their goods or services. The theory was also used to describe how pharmacies administer daily work. The developed research tools Observation tool We conducted field observations, a mixture of passive and participant observation (unstructured talks with pharmacy staff and owners), that were relevant for describing the administration of daily work as well as the leadership style and professional values of the pharmacy owners and staff. We developed a systematic observation tool reflecting the modified model by Sørensen [38, 39] to capture professional values in relation to how pharmacy staff deal with patients at the counter. For ethical and practical reasons, we did not consider it possible to use taped or video recordings. We decided that the 30-h observation period used in the pilot study would be appropriate for meeting the objectives of the study. Free field notes were taken on all chosen themes (see Fig. 1 for details about observation guide).

The developed theoretical framework

Group interview

We used a theory of leadership style when studying how the pharmacy owner had influenced the local process of implementation of the ITAS, as it was used to analyse leadership style in general. The specific theory was developed by Bolman and Deal, who distinguish between four mental frames when defining how leaders perceive organisations and act accordingly [37]. The four types are named the structural frame, the human resource frame, the political frame and the symbolic frame.

Interviews with three to four employees were undertaken in each of the included pharmacies to reconstruct the process of implementation. The pilot study had shown that employees as well as owners found it difficult to remember the ITAS-implementation process. One test group interview was subsequently carried out with a group of employees in a randomly chosen pharmacy. The results supported the idea of interviewing several employees at the same time. The interview also aided data source

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Observations: topics •how employees and owners coordinate daily tasks •how pharmacy owners communicate with their staff •how employees and owners deal in detail with asthma patients at the counter •how the ITAS is currently organised and carried out in the pharmacy Group interviews: topics •description of initiatives and activities in relation to implementation of the ITAS in the pharmacy •perceptions and explanations by employees on the profile of the monthly delivery of the service since the beginning (the profile was reproduced before the interview by the interviewer) and results of the pseudo customer surveys •ideas for improvement of implementation of the ITAS Semi structured interviews: topics •history of the pharmacy •preferred administration and coordination form of daily tasks •experience with cognitive services •view on environments •development of goals and visions •view on own leadership style •implementation of the ITAS •professional values in relation to the ITAS

Fig. 1 Observation and interviews guides

triangulation focusing on leadership style and professional values (see Fig. 1).


this analysis, we also conducted an exploratory form of analytical induction to see how leadership style as one aspect of the organisational context influenced the process of implementation. The perceptions of employees as to which factors influence their provision of the ITAS were first interpreted through ‘content analysis’. Leadership style was analysed in terms of both style in general and actions in relation to the ITAS through ‘content analysis’ and theory. The interpreted leadership style and the employees’ perceived ideas about the ITAS were then related through the use of common sense interpretation as described by Kvale: ‘i.e., critical assessments of statements validated by sufficient documentation to enable the reader to judge the logic of the arguments presented’ [41]. The results of the individual pharmacies were then integrated through analytic induction in order to develop contextual patterns that pertained to all included pharmacies. The developed research method can thus be characterised as a qualitative exploratory multi-case study. The research method was considered exploratory because the aim of the study was to induce new understandings of relationships between structural and process elements of the delivery of cognitive services rather than to interpret data according to one adequate theory. The research method was applied to seven pharmacies geographically spread around Denmark. The data was collected from April to October 2008.

Semi-structured interview Discussion A semi-structured interview with the pharmacy owner was conducted as a supplementary (triangulation) method of observing administration and leadership style. The interview with the owner was also used to obtain more details on the process of implementing the ITAS (see Fig. 1). In practice, method triangulation was implemented using the observations as an immediate source of all chosen themes. This new knowledge was then integrated into and elaborated on in the subsequent interviews, which allowed a more nuanced understanding of the local pharmacy practice as it unfolded. The observations were generally seen as the method for detecting how things happen; the interviews were seen as the method for exploring how they were perceived. The developed method of analysis We chose to carry out two different types of analyses. First, we undertook a cross-case analysis, as described by Yin [36], comparing how pharmacies with sustained delivery differ from pharmacies that have declined provision at present. Each of the theoretical interpreted themes was tested through the cross-case analysis. Using the results of

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In order to assess whether the new research method can contribute to the development of a targeted quality assurance system through establishing relationships between structural and process elements of the Danish ITAS, we will now address critical issues regarding the theoretical and practical preconditions of the study, discussing the transferability and the type of results we achieved through application of the research method as compared to that of the existing literature. One precondition of our research method was the concept of bottom-up, which advocates qualitative and local-sited research. Both a Danish and a Spanish study independently support studying the implementation process from the perspectives of local providers. These studies found that when developing and participating in projects to implement cognitive services, strategists and local providers differed with respect to their goals or which facilitators were more important for implementation [11, 42]. The study was further based on concepts of both data and method triangulation as perceived by Flick. A Danish PhD thesis on organisation and management in Danish community pharmacies supports the idea of using multiple


data sources to explore leadership style [43]. The study found significant differences in how owners and employees of the same pharmacy perceive the leadership style of the owner, which underlines the importance of interviewing both sides. Furthermore, the results of a study on counselling about blood pressure medicine indicate that there may be discrepancies between the self-perception of pharmacists on their own professional role and their actual professional practice [27]. The study therefore supports the idea of using method triangulation to explore professional values. As we studied only seven pharmacies, which nonetheless were very different, it is important to consider how the results can be transferred to other community pharmacies. We conducted two different types of analysis, which were both saturated in the sense that the final results consisted of induced contextual patterns that covered the ITAS implementation process in all included pharmacies. Thus, we believe that the results are transferable to Danish pharmacies that fulfil the definition of sustained or non-sustained providers according to how we sampled the pharmacies of the study. Other analytical approaches could also be considered relevant and possible using data obtained from our research method. This data flexibility could pave the way for the research method to be used in contexts other than the Danish implementation of ITAS for the pursuit of interests other than those of our research team. We found that the developed research method was satisfactory with regard to achieving an in-depth understanding of the relationships between the structural and process elements of the ITAS provision. We were able to achieve more nuanced results compared to other qualitative studies that were based on single-method approaches such as the application of semi-structured interviews. One example relates to the relationship between pharmacy staff skills and the provision of cognitive services. Both Hopp et al. [12] and Gastelurrutia et al. [11] identified professional counselling and clinical orientation as critical factors with regard to implementation. We have also found these factors to be important, but we could further illustrate how a lack of clinical competence is displayed subconsciously by staff in practice as well as the negative consequences this practice has for the patients. We find that knowledge reflecting not only if cognitive services are implemented but also in which way is essential when discussing the sustainable, safe and efficient provision of cognitive services. Such knowledge, we conclude, was created in this study through the triangulation of field observations and interviews combined with theoretical and ‘common sense’ interpretations. Thus, the results of studies that rely only on interviews and the perspective of local providers through ‘content analysis’ might in some cases be too simplistic or even deceptive.

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Roberts et al. [16] argue that it is important to include practitioners with experience in studies of implementation of cognitive services, as results are then presumed to reflect the experienced rather than perceived facilitators or barriers. To get results that also reflect the actual provision of services, which we found was an important supplement to the existing literature, we recommend a research method like ours that combines interviews with field observations. We did find one study that triangulated methods, but the observations were not part of this study [19]. Thus, the results of this study also represent experience-related factors that might to some extent be contradicted if observations were applied.

Conclusion We developed and applied a new exploratory case study research method to explore in-depth relationships between structural and process elements of the first Danish publiclyreimbursed cognitive service, the Inhaler Technique Assessment Service. We found the new research method useful in achieving a nuanced insight into how local organisational aspects such as staff competence shapes the actual provision of the service. The new research method can thereby be seen as a supplement to the existing literature on how to ensure the sustained delivery of cognitive services. The results of the applied methodology will in particular be used to develop generic quality indicators to further support the delivery of the ITAS. The results of the analyses of the study will be presented elsewhere. Funding The project was funded by the Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark as part of a PhD study. Conflict of interest The authors have no interest of conflict to declare.

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