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

Anne Estrup Olesen

Status: Completed

Conditions: Patient Safety; Medication Safety

Treatments: Other: Complex intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04990986

AalborgH2021-015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 436 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 2 patient groups

Intervention

Other group

Description:

The complex intervention will be co-developed during first phase of the study.

Treatment:

Other: Complex intervention

Control

No Intervention group

Description:

Half of the group will be included as control and thus not exposed to the intervention.