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NCT Number: NCT04990986

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

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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Key information

Conditions

Medication Safety Patient Safety

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital

Aalborg, 9000, Denmark

About this study

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:

  • 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?
  • 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?
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Complex intervention

Other

Will be co-developed during the study.

Primary outcomes

  1. Care staff's perceptions of patient safety culture

    Time frame: One year

    Safety Attitudes Questionnaire (SAQ)

Secondary outcomes

  1. Perceptions of patient safety culture of relatives of residents and nursing home doctors.

    Time frame: One year

    Qualitative data will be collected through individual interviews with relatives and GPs

Other outcomes

  1. Safety assessments

    Time frame: One year

    data from medical records and national registers will be used for safety assessments.

Sponsors and collaborators

Lead sponsor

Anne Estrup Olesen

Other

Collaborators

  • Aalborg Municipality
  • Aalborg University
  • University College of Northern Denmark

Registry information

Official study 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

Acronym: SAME

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2021
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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