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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Oct 14, 2022
Open Peer Review Period: Oct 14, 2022 - Oct 21, 2022
Date Accepted: Jan 24, 2023
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Safe Medication in Nursing Home Residents Through the Development and Evaluation of an Intervention (SAME): Protocol for a Fully Integrated Mixed Methods Study With a Cocreative Approach

Juhl M, Soerensen AL, Kristensen JK, Johnsen SP, Juhl MH

Safe Medication in Nursing Home Residents Through the Development and Evaluation of an Intervention (SAME): Protocol for a Fully Integrated Mixed Methods Study With a Cocreative Approach

JMIR Res Protoc 2023;12:e43538

DOI: 10.2196/43538

PMID: 37000508

PMCID: 10131653

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Safe Medication of Elderly Through Development and Evaluation of an Intervention (SAME): Protocol for a Fully Integrated Mixed Methods Study with Co-creative Approach

  • Marie Juhl; 
  • Ann Lykkegaard Soerensen; 
  • Jette Kolding Kristensen; 
  • Søren Paaske Johnsen; 
  • Marie Haase Juhl

ABSTRACT

Background:

Medication safety is increasingly of scope to face the challenge of patient safety in growing ageing populations. Developing positive patient safety cultures is acknowledged a primary goal to improve patient safety, but evidence on interventions to do so is inconclusive, not reflecting voices of nursing home residents- and their loved ones. Nursing home residents are often cognitively and physically impaired, therefore highly reluctant on frontline health care providers. Thus, studies on interventions to improve medication safety through patient safety culture among health care providers are needed to guide clinical practice within nursing homes, using integrating methods to ensure power of perspectives.

Objective:

The primary aim of the SAME study is to improve medication safety for elderly residing nursing homes focusing on patient safety culture in co-creation with residents, their relatives and frontline health care staff.

Methods:

A fully integrated mixed methods study covering a co-creative process with an integrated knowledge translational (IKT) approach. Patient safety culture within nursing homes will be explored through qualitative focus groups (Stage 1) to inform the development of an intervention in a multidisciplinary panel (Stage 2). Evaluation of the intervention will be done in a randomised controlled trial (RCT) set at nursing homes (Stage 3). The primary outcome will be changes in mean scale score of an adapted version of the Danish “Safety Attitudes Questionnaire” (SAQ-DK) for use in nursing homes. Patient safety related outcomes as risk-situation drugs, contacts to health care, diagnoses and mortality will be analysed through quantitative data collected through national registers. Finally, mixed methods analysis on patient safety culture in nursing homes will be done (stage 4), integrating qualitative data (Stage 1) and quantitative data (Stage 3) to comprehensively understand patient safety culture as a key to medication safety.

Results:

The SAME study is ongoing. Idea-and experience-groups (Stage 1) were carried out from April to September 2021 and the workshop in September 2021. Baseline SAQ-DK prim-data was collected in January 2022 with expected follow-up in January 2023. We expect to finish data-analysis in spring 2024.

Conclusions:

The SAME study will help generate evidence on patient safety culture that could help to inform- and guide future improvement-efforts within primary care settings, within political- and scientifical scope to meet an increasing challenge of medication safety. Clinical Trial: This study is registered at The North Denmark Region (2021-015), at Aalborg University (2021-068-01412) and in ClinicalTrials.gov (Identifier: NCT04990986).


 Citation

Please cite as:

Juhl M, Soerensen AL, Kristensen JK, Johnsen SP, Juhl MH

Safe Medication in Nursing Home Residents Through the Development and Evaluation of an Intervention (SAME): Protocol for a Fully Integrated Mixed Methods Study With a Cocreative Approach

JMIR Res Protoc 2023;12:e43538

DOI: 10.2196/43538

PMID: 37000508

PMCID: 10131653

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