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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Medication Safety Patient Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type OTHER

Complex intervention

Intervention Type OTHER

Will be co-developed during the study.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Complex intervention

Will be co-developed during the study.

Intervention Type OTHER

Eligibility Criteria

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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