Evaluating the implementation of health and safety innovations under a regulatory context: A collective case study of Ontario’s safer needle regulation

Klein and Sorra have defined implementation effectiveness as "the consistency and quality of targeted organizational members' use of [the] specific innovation" (p. 1058)[18]. When thinking about the adoption of safer needles, implementation effectiveness can be considered a state where conventional sharps have been replaced by safer alternatives. It may also include a state where there are clear expectations for the use of SEMDs, training is provided, workers value the added protection, and where workers consistently use the devices as intended. While implementation effectiveness models have identified organizational supports and processes that can promote the successful implementation of an innovation, less focus has been placed on describing additional external conditions that influence the implementation process. We have a limited understanding of the limitations and challenges experienced when adapting to regulatory requirements and the internal and external conditions that facilitate or impede change.

The organizational implementation effectiveness model modified for the healthcare sector[19] defines organizational factors thought to be most important in influencing implementation effectiveness. These factors include implementation climate, an implementation champion, clear and comprehensive implementation policies and procedures, innovation-values fit, management support, and financial resource availability[19]. While these factors have been found to be important in various settings and for different types of innovations[18‐23], it has been recognized that implementation is not only influenced by internal organizational factors. We currently have very little information on how external conditions influence the implementation process including the requirements to meet regulatory standards[23]. Regulation may have a role in shaping the types of policies and procedures that are adopted or even how staff perceives the utility and value of an innovation[23]. Regulation may empower individuals within an organization who have already recognized the value of organizational change but have faced internal resistance from senior management. Regulatory changes may also result is a subsequent increase in available external resources to support implementation. In many ways, the presence of regulation can also present some additional challenges for organizations as they implement a new innovation. For example, regulatory requirements often define an effective date for the adoption and implementation of a new requirement that provides a narrow window for organizations to make necessary changes. This may prevent the use of a more complex implementation strategy.

Figure1 presents a conceptual framework for this study that highlights 1) the stages of the implementation process that will be examined and 2) the levels of influencing factors on the implementation process. The structure of this framework was influenced by a simplified conceptual model from the implementation science literature which emphasizes the importance of examining multi-level influences on the implementation process[24]. The stages of change defined at the core of the conceptual model were informed by consultations with program managers in the Ontario hospital sector in addition to guidelines for the implementation of SEMDs[25]. While the model defines six stages, this study focuses on the last four: conversion, training, and review; worker compliance; monitoring and evaluation; and integration. Due to the fact that the regulation has been in effect for 4 years, it was assumed that the majority if not all acute care hospitals in Ontario would have initiated some activities to implement SEMDs.

The stages of change defined at the core of the conceptual framework are surrounded by influencing factors on the implementation process. The selection of organizational and external influencing factors was influenced by the implementation effectiveness model[18, 19] in addition to other concepts in the implementation science and occupational health and safety literature[4, 26‐35]. The conceptual model represents a starting point for thinking about the implementation process and conditions that may facilitate or impede the integration of SEMDs.

A qualitative study is proposed. Understanding unique implementation experiences within different organizational contexts requires detailed description and an open-ended and discovery-oriented process[36]. The study is guided by a critical realist perspective[37]. This perspective carries specific assumptions that have implications for the design, field work, and analysis[38, 39]. When following this perspective, there is a tendency to focus on structures, mechanisms and processes in context. The specific unit of analysis is seen as being influenced by multiple levels including institutional forces (e.g., regulation, organizational policies) and individual behavior (action, language, cognitive processes)[37]. Theory will play an important interactive role throughout the study framing the initial focus but also allowing for new emerging ideas and theoretical explanations.

The study will use a collective case study design[40]. The cases are instrumental to understanding collectively how Ontario’s safer needle regulation played out in acute care hospitals. The case study design is often used when the unit of analysis focuses on organizational change. In this study, a case study design allows the implementation experience to be examined within the broader context of the priorities, constraints and processes of the organization.

The study will focus on acute care hospitals in Ontario. Acute care hospitals were the first healthcare setting to be targeted by Ontario’s safer needle regulation; therefore, they have had a longer period of time to comply with the regulatory requirements. This provides an opportunity to focus on issues that arise during later stages of implementation, a period during the implementation cycle that has been understudied[24]. Second, focusing on acute care hospitals provides an opportunity to examine the implementation of SEMDs in a complex setting requiring the implementation of a broad range of different devices across different clinical departments where the types of healthcare workers, procedures and hazards will vary greatly.

The selection of organizations and the selection of informants will follow both a random and purposive sampling approach. The eligible sample of potential organizations includes all general or teaching hospitals that are within 40 kilometers from two offices held by the primary investigator. This includes 22 hospital sites, 3 of which are located in Ottawa and 19 in Toronto. The sample includes 8 teaching hospitals and 14 community hospitals. Hospital sites will be listed under three categories representing a) community hospitals in Toronto, b) teaching hospitals in Toronto and c) both teaching and community hospitals in Ottawa. Sites will be randomly selected from each category.

Organizations will be recruited with the assistance of consultants from a health and safety association in Ontario. At each hospital, the director of occupational health and safety will be contacted to discuss the study requirements and opportunities. Permission for the study to be carried out within the organization will be received from the organization's central gatekeeper (whose job title will vary between organizations). During this early recruitment phase, senior level employees and the organization's joint health and safety committee will be informed about the study.

At each site, information will be collected from two groups including organizational informants and front-line healthcare workers. Organizational informants are considered to be staff that had a direct role in the selection and integration of SEMDs which may include the director or manager of occupational health and safety, joint health and safety committee representatives, staff from professional practice, purchasing managers, infection control professionals and members of the sharps safety committee. The second group of participants will include healthcare workers with or without a direct safety role including unit managers and front line registered nurses. As hospitals have a very complex structure with multiple departments, interviews will be conducted with staff in two departments which will be selected in consultation with the director of occupational health and safety. Selection will be based on the extent to which safety needles are used on a regular basis within each department and other practical constraints (e.g., department restructuring, involvement in other ongoing research projects).

At each site, it is anticipated that 2-4 interviews will be conducted with organizational informants depending on the number of employees and groups directly involved in the implementation process. To identify workers within each department, a snowball sampling approach will be used where early informants at the senior and middle management level will send the recruitment invitation to other eligible employees. This study will consider ‘data saturation' (a stage where interviews are no longer providing new information or perspectives) as a primary criterion to decide when a sufficient number of interviews has been carried out[41, 42]. It is anticipated that 8-10 interviews with front-line healthcare workers per site will be required to reach data saturation.

The implementation of SEMDs was a large and complex undertaking involving several organizational stakeholders at various levels within the organization. To help narrow the focus of the field work, an advisory committee was established with four individuals who had a key role in the development and implementation of Ontario’s safer needle regulation. The committee members were from regulatory, labour, and not-for-profit health and safety organizations. The role of the committee was to ensure the study was focused on the most pertinent issues and that key organizational informants were recruited. Through this consultation process a preliminary list of foreshadowed issues and topical questions about the case has been developed (Table1). Foreshadowed issues serve as an initial conceptual structure defining what particular aspects of the case are of interest. They are meant to evolve overtime. Topical questions will also be used to guide the collection of more contextual information about the case.

Data for this study will be collected via qualitative interviews and document analysis. Information will be collected from the three sites over a 9 month period. Field notes will be used to document the data collection process. The interviews will be guided by a semi-structured interview guide that will aim to ask broad questions about the implementation process and experience. The interview questions will evolve over the course of the study to accommodate the emerging findings of the case. Working with the informants in the department of occupational health and safety, any available supporting documents related to the organization’s strategy for implementing SEMDs will be reviewed. Relevant documents may include incident reports, newsletters, policies and procedures, meeting minutes, and program manuals.

The data for the analysis will include interview transcripts, field notes, and relevant organizational documents. Audio recordings will be transcribed verbatim by a transcriptionist and checked for accuracy by the research investigator.

The analysis will be treated as an ongoing process[43]. Case summary forms will serve as an analytical device and as a guide to the data collection process. Following each interview, a case summary form will be completed to highlight the main issues or themes identified from the initial review of the data and to summarize the information obtained. The foreshadowed issues and topical questions will influence the direction of the analysis including the content of the case descriptions[40]. The analysis can be described as following an interactive approach where both the empirical data and imported theory will constantly inform each other[43].

The analysis will have five key steps: immersion in the data, first level coding, second level coding, explanation and interpretation of categories, and cross-case analysis. During the first level coding process, descriptive codes will be applied to sections of data to summarize the data collected, assist with pattern identification and interpretation, and guide the identification of relevant text across interviews, documents and cases. First level coding will be followed by pattern coding[43, 45]. Memoing will be used throughout the coding process as a strategy to identify and discuss promising codes that emerge from pattern coding and also to document the analysis process.

The general strategy will be to conduct analyses on each case individually before carrying out any cross-case analyses. The process of coding, memoing and documenting the analysis will be assisted with the use of NVivo (QSR International Pty Ltd. Version 9, 2010). The software will be used to help organize the large amount of data collected throughout the study, keep track of codes, and centralize and document the analysis process. The study aims to produce a descriptive case report for each site in addition to assertions based on the cross-case analysis.

Each case report will include an extensive description of each hospital’s strategy and contextualized experience of the integration of SEMDs highlighting specific issues and drawing on multiple perspectives from the interview informants. The analysis and interpretation process will generate some theoretical propositions regarding the relevance of existing concepts in the implementation science literature. A cross-case analysis will highlight themes and produce a series of assertions that will examine lessons learned about the implementation of SEMDs and the impact of the regulation.