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 (Preprint)

Abstract

BACKGROUND Medication safety is increasingly of scope to face the challenge of patient safety in growing ageing populations. Developing positive patient safety cultures is acknowledged a primary goal to improve patient safety, but evidence on interventions to do so is inconclusive, not reflecting voices of nursing home residents- and their loved ones. Nursing home residents are often cognitively and physically impaired, therefore highly reluctant on frontline health care providers. Thus, studies on interventions to improve medication safety through patient safety culture among health care providers are needed to guide clinical practice within nursing homes, using integrating methods to ensure power of perspectives. OBJECTIVE The primary aim of the SAME study is to improve medication safety for elderly residing nursing homes focusing on patient safety culture in co-creation with residents, their relatives and frontline health care staff. METHODS A fully integrated mixed methods study covering a co-creative process with an integrated knowledge translational (IKT) approach. Patient safety culture within nursing homes will be explored through qualitative focus groups (Stage 1) to inform the development of an intervention in a multidisciplinary panel (Stage 2). Evaluation of the intervention will be done in a randomised controlled trial (RCT) set at nursing homes (Stage 3). The primary outcome will be changes in mean scale score of an adapted version of the Danish “Safety Attitudes Questionnaire” (SAQ-DK) for use in nursing homes. Patient safety related outcomes as risk-situation drugs, contacts to health care, diagnoses and mortality will be analysed through quantitative data collected through national registers. Finally, 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. RESULTS The SAME study is ongoing. Idea-and experience-groups (Stage 1) were carried out from April to September 2021 and the workshop in September 2021. Baseline SAQ-DK prim-data was collected in January 2022 with expected follow-up in January 2023. We expect to finish data-analysis in spring 2024. CONCLUSIONS The SAME study will help generate evidence on patient safety culture that could help to inform- and guide future improvement-efforts within primary care settings, within political- and scientifical scope to meet an increasing challenge of medication safety. CLINICALTRIAL This study is registered at The North Denmark Region (2021-015), at Aalborg University (2021-068-01412) and in ClinicalTrials.gov (Identifier: NCT04990986).