Co-Development and Evaluation of a Complex Intervention t... | NCT04990986

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

NCT04990986

Sponsor

Anne Estrup Olesen

Status

Completed

Last Update Posted

May 1, 2024Actual

Enrollment

436Actual

Phase

Not Applicable

Conditions

Medication Safety
Patient Safety

Interventions

Complex intervention

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Oct 31, 2023Actual

First Submitted Date

Jun 30, 2021

First Submission Date that Met QC Criteria

Aug 3, 2021

First Posted Date

Aug 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2024

Last Update Posted Date

May 1, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anne Estrup Olesen, Professor, Aalborg University HospitalSponsor-Investigator

Lead Sponsor

Anne Estrup OlesenOTHER

Collaborators

Name	Class
Aalborg University	OTHER
Aalborg Municipality	OTHER
University College of Northern Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

436Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Complex intervention	Other	Will be co-developed during the study.	Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne E Olesen, Ph.D.	Aalborg University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg University Hospital		Aalborg		9000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37000508	Derived	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.