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

NCT04990986 | Completed

• 1 other identifier: AalborgH2021-015
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medication Safety; Patient Safety

Outcome Measures

Primary Outcomes (1)

• Care staff's perceptions of patient safety culture

  Safety Attitudes Questionnaire (SAQ)

  One year

Secondary Outcomes (1)

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

  One year

Other Outcomes (1)

• Safety assessments

  One year

Study Arms (2)

Intervention

OTHER

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

Other: Complex intervention

Control

NO INTERVENTION

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

Interventions

Complex intervention OTHER

Will be co-developed during the study.

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Anne Estrup Olesen: lead
• Aalborg University: collaborator
• Aalborg Municipality: collaborator
• University College of Northern Denmark: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

• Juhl MH, Soerensen AL, Kristensen JK, Johnsen SP, Olesen AE. 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 Mar 31;12:e43538. doi: 10.2196/43538.

  PMID: 37000508 DERIVED

Study Officials

• Anne E Olesen, Ph.D.

  Aalborg University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 5, 2021
• Study Start: October 1, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We plan to publish the protocol during fall 2021

Locations

DK (1)