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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patient Safety; Medication Safety
• Intervention / Treatment: Other: Complex intervention

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 Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne E Olesen, Ph.D.; Phone Number: +4597664376; Email: aneso@rn.dk
• Study Contact Backup: Name: Marie Juhl, MD; Phone Number: +4597664376; Email: marie.juhl@rn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
    • Contact: Anne E Olesen, Ph.D; Phone Number: +4597664376; Email: aneso@rn.dk
    • Contact: Marie H Juhl, MD; Phone Number: +4597664376; Email: marie.juhl@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; The complex intervention will be co-developed during first phase of the study.	Other: Complex intervention; Will be co-developed during the study.
No Intervention: Control; Half of the group will be included as control and thus not exposed to the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Care staff's perceptions of patient safety culture	Safety Attitudes Questionnaire (SAQ)	One year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessments	data from medical records and national registers will be used for safety assessments.	One year

Collaborators and Investigators

• Sponsor: Anne Estrup Olesen
• Collaborators: Aalborg University; University College of Northern Denmark; Aalborg Kommune
• Investigators: Study Director: Anne E Olesen, Ph.D., Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AalborgH2021-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to publish the protocol
• IPD Sharing Time Frame: We plan to publish the protocol during fall 2021
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No