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      Safe Medication in Nursing Home Residents Through the Development and Evaluation of an Intervention (SAME): Protocol for a Fully Integrated Mixed Methods Study With a Cocreative Approach


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          Medication safety is increasingly challenging patient safety in growing aging populations. Developing positive patient safety cultures is acknowledged as a primary goal to improve patient safety, but evidence on the interventions to do so is inconclusive. Nursing home residents are often cognitively and physically impaired and are therefore highly reliant on frontline health care providers. Thus, interventions to improve medication safety of nursing home residents through patient safety culture among providers are needed. Using cocreative partnerships, integrating knowledge of residents and their relatives, and ensuring managerial support could be beneficial.


          The primary aim of the Safe Medication of Nursing Home Residents Through Development and Evaluation of an Intervention (SAME) study is to improve medication safety for nursing home residents through developing an intervention by gaining experiential knowledge of patient safety culture in cocreative partnerships, integrating knowledge of residents and their relatives, and ensuring managerial support.


          The fully integrated mixed method study will be conducted using an integrated knowledge translation approach. Patient safety culture within nursing homes will first be explored through qualitative focus groups (stage 1) including nursing home residents, their relatives, and frontline health care providers. This will inform the development of an intervention in a multidisciplinary panel (stage 2) including cocreators representing the medication management process across the health care system. Evaluation of the intervention will be done in a randomized controlled trial set at nursing homes (stage 3). The primary outcome will be changes in the mean scale score of an adapted version of the Danish “Safety Attitudes Questionnaire” (SAQ-DK) for use in nursing homes. Patient safety–related outcomes will be collected through Danish health registers to assess safety issues and effects, including medication, contacts to health care, diagnoses, and mortality. Finally, a mixed methods analysis on patient safety culture in nursing homes will be done (stage 4), integrating qualitative data (stage 1) and quantitative data (stage 3) to comprehensively understand patient safety culture as a key to medication safety.


          The SAME study is ongoing. Focus groups were carried out from April 2021 to September 2021 and the workshop in September 2021. Baseline SAQ-DK data were collected in January 2022 with expected follow-up in January 2023. Final data analysis is expected in spring 2024.


          The SAME study will help not only to generate evidence on interventions to improve medication safety of nursing home residents through patient safety culture but also to give insight into possible impacts of using cocreativity to guide the development. Thus, findings will address multiple gaps in evidence to guide future patient safety improvement efforts within primary care settings of political and scientific scope.

          Trial Registration

          ClinicalTrials.gov NCT04990986; https://clinicaltrials.gov/ct2/show/NCT04990986

          International Registered Report Identifier (IRRID)


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              Achieving integration in mixed methods designs-principles and practices.

              Mixed methods research offers powerful tools for investigating complex processes and systems in health and health care. This article describes integration principles and practices at three levels in mixed methods research and provides illustrative examples. Integration at the study design level occurs through three basic mixed method designs-exploratory sequential, explanatory sequential, and convergent-and through four advanced frameworks-multistage, intervention, case study, and participatory. Integration at the methods level occurs through four approaches. In connecting, one database links to the other through sampling. With building, one database informs the data collection approach of the other. When merging, the two databases are brought together for analysis. With embedding, data collection and analysis link at multiple points. Integration at the interpretation and reporting level occurs through narrative, data transformation, and joint display. The fit of integration describes the extent the qualitative and quantitative findings cohere. Understanding these principles and practices of integration can help health services researchers leverage the strengths of mixed methods. © Health Research and Educational Trust.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                31 March 2023
                : 12
                : e43538
                [1 ] Department of Clinical Medicine Aalborg University Aalborg Denmark
                [2 ] Department of Clinical Pharmacology Aalborg University Hospital Aalborg Denmark
                [3 ] University College of Northern Denmark Aalborg Denmark
                [4 ] Research Unit for General Practice in Aalborg Aalborg University Aalborg Denmark
                [5 ] Danish Center for Health Services Research Department of Clinical Medicine Aalborg University Aalborg Denmark
                Author notes
                Corresponding Author: Anne Estrup Olesen aneso@ 123456rn.dk
                Author information
                ©Marie Haase Juhl, Ann Lykkegaard Soerensen, Jette Kolding Kristensen, Søren Paaske Johnsen, Anne Estrup Olesen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 31.03.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), 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 https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 14 October 2022
                : 22 December 2022
                : 11 January 2023
                : 24 January 2023

                protocols and guidelines,medication safety,cocreation,user involvement,health and safety within primary care,research in nursing home care,mixed methods


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