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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Medication Safety
- Sponsor
- Anne Estrup Olesen
- Enrollment
- 436
- Locations
- 1
- Primary Endpoint
- Care staff's perceptions of patient safety culture
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The study aims 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.
Detailed Description
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.
Investigators
Anne Estrup Olesen
Professor
Aalborg University Hospital
Eligibility Criteria
Inclusion Criteria
- •involved directly or indirectly in the medication process
- •employment of at least two months in a nursing-home within the municipality of Aalborg, sufficient spoken and written Danish language
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Care staff's perceptions of patient safety culture
Time Frame: One year
Safety Attitudes Questionnaire (SAQ)
Secondary Outcomes
- Perceptions of patient safety culture of relatives of residents and nursing home doctors.(One year)