Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes - A Mixed Methods Study Embedding a Cluster Randomised Controlled Trial, Guided by Safety Theory With Participatory Approach

In the SAME-study, we aim to develop and evaluate a new, multifaceted (complex) intervention in a mixed methods study-design to increase medication safety in nursing homes. The SAME-study will be locally anchored, including investigation of patient safety culture, in a mixed methods design, including both in depth qualitative and organizational-focused quantitative methods. This study will be guided by the following main research questions and hypothesis:

1. Can we elucidate new areas susceptible for intervention to increase medication safety in nursing homes through qualitative in-depth investigation of patient safety culture in nursing homes guided by safety theory with participatory approach?
2. Is it possible to develop a multifaceted intervention fit to context within actual resource-frame to increase medication safety in nursing homes based on patient safety culture, guided by safety theory with participatory approach?
3. A complex intervention developed within a participatory framework will lead to positive change of care-staff self-reported perceptions of patient safety climate culture in nursing homes in the intervention group compared with the control group of this study?

Study design This study applies mixed-methods pragmatic paradigm led by Safety 1 and 2 theory, with participatory approach to an exploratory sequential three-phased study-design, embedding a randomized controlled trial (cRCT). Overall study-settings will be nursing homes within the municipality of Aalborg, North Denmark Region, Denmark.