Despite years of focus, medication safety is still troubling patient safety globally, with increasing demands on health care systems challenged by aging populations [1]. Physical and social environments constitute system factors that are thought to be the main factors influencing health of older adults [2]. Medication errors and unsafe medication practices are the leading causes of avoidable harm in health care, playing a key role in jeopardizing patient safety. Nursing home residents constitute a marginalized, medically complex, and underresearched group who are in high risk of experiencing preventable medication-related harm [3]. Worldwide, older adults in need of specialized health care delivery through primary care, including nursing home care, is expected to increase [2,4]. In terms of improving medication safety in primary health care settings, focus on the most dangerous aspects of systems and the people who are most at risk have been suggested [5]. Highest rates of preventable medication harm have been found in older adult patient care settings [6]. Moreover, nursing homes provide health care for the older adults who are most at risk of experiencing risk factors of medication errors [3,7-9]. In 2021, an 11% increase in adverse events, with a total of 326.416 adverse events, was reported by the Danish Patient Safety Authority in Denmark, and approximately 60% of the events were related to medication errors. A substantial proportion of this increase is reported from municipality health care settings, including nursing homes. This is supported by international findings regarding medication errors in European nursing homes and community care context [7,8,10]. Thus, focus on the interventions to improve medication safety of older adults living in nursing homes is needed. Moreover, multiple work system factors, including persons (resident and staff), organization, tools and technology, tasks, and environment, have been found to affect medication safety in nursing homes. One of the organizational factors, namely, interprofessional collaboration was reported as a relevant factor [11]. These findings reflect recent suggestions for taking a systems approach with focus on organizational issues in terms of minimizing mistakes related to the medication management process [12]. Managing medication of nursing home residents is a highly complex task, often implicating a relatively invisible, multidisciplinary, and cross-sectoral team of health care professionals, providers, as well as the residents and their relatives [13]. However, existing literature remain sparse, heterogenous, and inconclusive when it comes to interventions to improve medication safety in nursing homes [14].

Absence of accidents and incidents is often referred to as safety, which is, ensuring that things do not go wrong. The theoretical underpinning can be defined as Safety I theory, which has been the primary driver of safety improvement efforts globally [15]. Nevertheless, as primary health care constitutes a complex system structure, safety cannot be hypothesized to be achieved through measuring errors to avoid them from reoccurring. The human ability to adapt to varying conditions, thereby increasing resilience within health care systems, cannot be overruled. In theoretical terms this can be defined as Safety II theory, where understanding why things go right most of the time becomes the primary investigatory question to answer [15]. Safety II theory has recently been suggested as a guidance to avoid harm in health care [16], thus enabling prevention of errors through determining underlying mechanisms and resources already in play before errors happen and improving patient safety through no-blame cultures in nursing homes [17]. However, there are no specific evidence-based guidelines on how to realize such safety culture [18,19]. Knowledge on the effects of quality improvement initiatives and interventions to improve medication safety in primary care is based on sparse, highly heterogenous evidence [20,21]. In Denmark, nursing homes are under the responsibility of municipalities who constitute an important part of primary health care. The nursing home setting is highly complex, being both a private home and a center of health care delivery for the residents.

Development and evaluation of interventions fit to the complex context of nursing homes in large-sample, longitudinal studies have been suggested beneficial to obtain positive, long-lasting effects on medication safety [22]. Within hospital settings, multifaceted approaches and inclusion of stakeholders has been found to be associated with a decrease in medication errors and a positive change in patients’ satisfaction [23]. This supports earlier studies arguing that future interventions targeting medication safety could benefit from being based on multidisciplinary teams focusing on quality as a shared commitment; being multifaceted; and involving all stakeholders, including residents and their relatives [24,25]. Nevertheless, findings are contradictory. A recent study investigating a multifaceted intervention to improve medication safety of nursing home residents did not find positive effects on the health status of nursing home residents [22], contrary to a study aimed to improve medication safety in a hospital setting through a multifaceted interventional strategy [23]. Overall, studies on interventions to improve medication safety in residential health care for older adults are heterogenous in terms of methodologies with inconclusive results [14]. This corresponds to findings of a review on the interventions to optimize medication use within nursing homes [26].

Thus, medication errors and unsafe medication practices continue to concern health care systems worldwide, including nursing home settings. However, earlier research clearly reflects a gap in the knowledge about interventions to improve medication safety in nursing home settings. Patient safety culture is acknowledged as a key to patient safety, both in terms of improvement and effect evaluation [16,27-29] and has been associated with medication errors, also showing improvement potential [19,30]. In 2021, a guiding report on avoiding harm in health care added the importance of focus on primary health care settings, involvement of stakeholders, and cocreation to conquer the challenge of patient safety, including medication safety [16]. Moreover, safety cultures were recommended to be integrated within research designs and as for efforts within health care organizations [16]. This is in alignment with the most recent health work paper by the Organization for Economic Cooperation and Development stating patient safety culture as a recognized factor of importance at all levels of health care. Moroever, instruments to measure patient safety cultures are already in use in 20 of 24 member countries [20].

Patient safety culture is a complex phenomenon that is thought as a subclass of organizational cultures referring to the safety culture related to patients [21]. It is defined as “the values shared among organization members about what is important, their beliefs about how things operate in the organization, and the interaction of these with work unit and organizational structures and systems, which together produce behavioral norms in the organization that promote safety” [31]. Instruments that aim to capture reflections of patient safety cultures have been developed and validated [20,32], with one of the most widely translated and adapted being the “Safety Attitudes Questionnaire” (SAQ), originally developed in the United States in 2006 [33]. The SAQ can be used with dualistic perspectives both to compare different health care employees perceptions and to monitor changes over time [32]. In addition, it allows for comparison between large numbers of sites across settings [33]. Although evidence is sparse and contradictory [34], there is evidence indicating that SAQ is a proper proxy measure of patient safety [35]. SAQ scores have been reported to be directly associated with patient outcomes [32]. The SAQ has been adapted and validated for use in both secondary care and primary care settings [36-40], including Western European nursing homes [38,41] and Danish hospital settings [36].

The SAME study applies an overall theory-informed, fully integrated mixed methods study design that includes an exploratory sequential and IKT-guided research process, integrating 2 work packages including a cocreative intervention developing process (stages 1 and 2) and an evaluative process, including RCT (stage 3) and mixed methods integrative analysis of the intervention (stage 3 and 4). Integration will occur at design, method, and reporting levels to reach comprehensive understanding of patient safety culture as a target to improve medication safety. The SAME study aims to reach partnership-developed results through an IKT approach, thereby increasing the chances of achieving translation of research into practice with a focus on the empowerment of stakeholders, end users, and decision makers to generate useful, meaningful, acceptable, and feasible results. Thus, shifting roles of knowledge users to cocreators will be of primary focus throughout the study (Figure 1). To follow current political recommendations to shift perspective in terms of patient safety, Safety II theory [15] will inform data collection.

Nursing homes registered within the Municipality of Aalborg, The North Denmark Region, Denmark, constitute the main setting of the SAME study. A nursing home is defined as “a facility with a domestic-styled environment that provides 24-hour functional support and care for persons who require assistance with activities of daily living and who often have complex health needs and increased vulnerability” [51].

A purposive sampling strategy will be followed through all the stages of SAME, conducted in partnership between the research team and municipal advisory board. The municipal advisory board will actively take part in recruitment through establishing contact with eligible cocreators (stages 1, 2, and 3) and participants (stage 3), including those employed at nursing homes, by sending out information material electronically (email). The research team will be responsible for the recruitment of cocreators not directly employed within municipal settings, including an external consultant in cocreativity and communication, risk managers at hospitals, and volunteers representing nursing home residents and their relatives.

Participants will be eligible for inclusion in the SAME study according to the following criteria: (1) sufficient knowledge of spoken Danish language, (2) being directly or indirectly implicated in the medication management process of nursing home residents, (3) being employed for >2 months at a nursing home registered within the Municipality of Aalborg, and (4) being actively engaged in older adult health care at political or societal level within the Municipality of Aalborg. To represent nursing home residents, we aim to include volunteers from “the senior-council Aalborg” and “The council of elderly” (Table 1); both the groups are characterized by independent, voluntary participation.

We aim to achieve active engagement and empowerment of patients, health care professionals, decision makers and other stakeholders through developing partnerships, with emphasis on equal power but acknowledgment of different roles and responsibility (Table 1). To do so, an overall iterative IKT approach will be applied. IKT is viewed as “an approach or set of processes that can lead to the generation of knowledge for optimizing health care delivery systems and improving health system performance and associated outcomes” [52]. A total of 8 IKT guiding principles are available to support meaningful research, mitigating risk of tokenism. Although relatively recent, the IKT approach has been found useful in other research areas [48] and is in broad terms similar to other collaborative research approaches, including aiming at true partnerships rather than simple engagement; focusing on essential components and processes rather than labels; enabling collaborative research orientations rather than research methods, core values, and principles; and extensive time and financial investment [53]. Thus, in the SAME study, we aim to shift participants and researchers to the role of cocreators following an IKT approach. For practical implication, cocreators include the term “knowledge user” referring to “…an individual who is likely to be able to use the knowledge generated through research to make informed decisions about health policies, programs and/or practices” and “stakeholders” as “individuals, groups or organisations with shared interest in the research; may be in the geographic locality of the research setting or it may be affected by the environmental effects of the research but may not necessarily use the generated knowledge” [54]. To describe and evaluate the level of participation, we will use the International Association for Public Participation Spectrum of Public Participation [55].

Thus, we aim to develop an intervention that will improve medication safety of the older adults with frailty living in nursing homes, and it will be based on coknowledge, generating results perceived as meaningful, useful, acceptable, and feasible by those affected by the research to inform clinical practice. This could help support the ongoing development of sustainable, accessible, and equitable health care systems [56], making room for positive change.

Table 1 shows an overall presentation of participants in the SAME study. We aim to achieve equally powered partnerships between participants and researchers, shifting participants and researchers into the role of cocreators [53] divided into subgroups following the SAME study IKT approach [57].

The primary objective of stage 1 is to explore patient safety culture in nursing homes, with the perspectives of frontline health care providers being the primary focus. Experienced knowledge will inform the development of the intervention (stage 2) collected through semistructured focus group interviews [58,59]. In addition, field notes will be used as a data source. The medication management process of nursing home residents will be integrated in the development of the semistructured interview guide to ensure the development through medication safety lens of the SAME study.

In stage 2, the design of the new intervention will be formed. This will be done in a 2-phased process embedded a co-designing process. First, we aim to develop idea generation in a multidisciplinary panel representing a systems view in terms of the medication management process of nursing home residents, and the panel includes nursing home residents and their relatives as well as decision makers. Second, triangulation of ideas will be done with focus on research knowledge. To meet the possibility of using an inadequate number of cocreators to reflect the entire system, the cocreative process will include the investigation of acceptance and usefulness of the intervention through semistructured qualitative focus group interviews with knowledge users and stakeholders in stage 3. The municipal advisory board will play an essential role in stage 2, acting not only as partners in idea generation but also as decision makers in relation to the final intervention design.

In stage 3, we will evaluate the new intervention in a randomized controlled study set at nursing homes. Data on primary outcome will be collected at baseline before rollout of the intervention and at 6-month to 9-month follow-up according to intervention rollout at individual participating nursing homes. Data on secondary outcomes will be collected during the intervention period.

Through a mixed methods integrative analysis, the SAME study aims to gain comprehensive understanding of patient safety culture as a multilayered construct and target of medication safety intervention (stage 4) via different data sets, including (1) a quantitative questionnaire on nursing home care staff and nursing home management’s (Table 1) self-reported perceptions of patient safety climate (SAQ-DK), (2) qualitative data on patient safety culture, and (3) qualitative data from individual interviews with knowledge users. The different sets of data will be collected and analyzed separately for final integration through use of “joint display of data” [67] in a mixed methods analysis. Results could lead to the development of a new theory on patient safety cultures in Danish nursing homes, informing future research and clinical practice in the area.

To impact decision-making, research could benefit from including multiple ways of understanding complex concepts leading to new understanding [68]. Thus, study designs combining mixed methods with participatory approaches could improve research outcome with increasing complexity of the area under investigation, allowing for a deeper understanding of complex phenomena [69-72]. Although sparse, mixed methods studies have been reported, underpinning the benefits in the development and evaluation of interventions [73-75]. Community-based organizations are important stakeholders in health systems, often called upon to use research evidence to inform health care delivery [76]. Consulting key stakeholders and service users, therefore, seems crucial to allow for evidence that is “probably more realistic, acceptable and likely to produce more change” [68]. Combining mixed methods with participatory research approach can help the translation of research into practice and may facilitate meaningful, evidence-based change [69]. Moreover, integration can occur at the level of knowledge. Thus, it is expected that integrative mixed methods analysis including in-depth qualitative exploration will provide a more comprehensive understanding of the complex phenomenon of patient safety culture within high-risk primary care settings, minimizing risk of generating misleading results to guide future clinical practice.

IKT can be used to identify a problem and be able to implement the research recommendations through collaborative research processes. This will form partnerships between researchers and service users [57] aiming to produce meaningful, useful, acceptable, and effectful results [52,57,77]. Importantly, perspectives of representants of an entire organization should be accounted for in terms of investigating safety cultures [44]. Patient participation in the medication process has been stated essential in preventing adverse events, including medication errors [78]. This supports the acknowledgment of patient involvement to avoid harm in health care [16]. Moreover, a scoping review on the IKT approach reported by few studies that included patients who are knowledge users as partners, whereas decision makers were highly represented. Thus, it is anticipated that the IKT approach of the SAME study will increase the chance of identifying and acting upon needs and priorities of knowledge users, including decision makers, nursing home care staff, nursing home residents, and their loved ones, who are rarely integrated as active partners within research on patient safety culture.

The SAME study will provide insight and knowledge to bridge the gap between research and clinical practice on medication safety strategies targeting older adults with frailty, with emphasis on cocreation. Moreover, understanding patient safety culture through an integrative method could lead to new opportunities of using and analyzing results based on instruments already in play. Including the SAQ as a primary outcome will help generate comparable results. This could increase learning potential across national borders, health care sectors, and local health care organizations and departments as a key to meet the global challenge of patient safety [20]. There is a possibility that results generated could guide the development of a novel framework to facilitate cocreation to improve medication safety in nursing homes.