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NCT04990986 Clinical Trial

Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes

Patient Safety Clinical Trial

— SAME  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04990986
Other study ID # AalborgH2021-015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date October 31, 2023

Study information
Verified date April 2024
Source Aalborg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 436
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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: -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Complex intervention
Will be co-developed during the study.

Locations
Country Name City State
Denmark Aalborg University Hospital Aalborg

Sponsors (4)
Lead Sponsor Collaborator
Anne Estrup Olesen Aalborg Kommune, Aalborg University, University College of Northern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Safety assessments data from medical records and national registers will be used for safety assessments. One year
Primary Care staff's perceptions of patient safety culture Safety Attitudes Questionnaire (SAQ) One year
Secondary Perceptions of patient safety culture of relatives of residents and nursing home doctors. Qualitative data will be collected through individual interviews with relatives and GPs One year
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