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

Not Applicable

Completed

• Conditions: Patient Safety; Medication Safety

• Registration Number: NCT04990986
• Lead Sponsor: Anne Estrup Olesen

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.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-05
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Care staff's perceptions of patient safety culture	One year	Safety Attitudes Questionnaire (SAQ)

Secondary Outcome Measures

Name	Time	Method
Perceptions of patient safety culture of relatives of residents and nursing home doctors.	One year	Qualitative data will be collected through individual interviews with relatives and GPs

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark