Model for Safety Culture by Empowering the Family at Home: a Mixed-methods Study Protocol
Development of the Ageing Safety From the Risk (ASRi) Model for Safety Culture by Empowering the Family at Home: a Mixed-methods Study Protocol
1 other identifier
interventional
136
1 country
1
Brief Summary
Background: The elderly are a vulnerable group for health problems as they age. Safe care is essential when caring for the elderly at home because adverse events can happen there, such as falls, pressure ulcers, injuries, or dangers caused by medication errors. Safety culture for the elderly at home needs to be developed so that they can avoid unexpected events. This study aimed to develop the model for safety culture among the elderly called Aging Safe from the Risk (ASRi) to improve the safety culture in elderly care at home. Methods: This exploratory sequential mixed methods study will consist of three stages. Stage 1, a qualitative descriptive study, will be conducted to explore the perceptions of families, nurses, and school administrators for the elderly regarding the safety of the elderly at home. Data will be collected by interviews and focus group discussions. Stage II will involve developing The ASRi model using the modified Delphi method. The list of elderly safety culture indicators will be assessed by experts and then further developed into a model. In stage III, a model test will be conducted with a non-equivalent control group using a quasi-experimental design. The investigators will provide interventions in the form of education and training to families regarding the safety culture for the elderly at home. Findings: There is a crucial need for studies assessing the safety culture in elderly care by empowering families at home to improve safety for the elderly. The results of this study will help fill the knowledge gap in this research and can aid in developing public health policy and programs for the elderly. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2021
CompletedFirst Submitted
Initial submission to the registry
July 10, 2022
CompletedFirst Posted
Study publicly available on registry
August 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 4, 2022
August 1, 2022
1.3 years
July 10, 2022
August 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of safety culture
Rate of safety culture will be measured by instrument of safety culture that modified from the Nursing Home Patient Safety Culture and the results of Delphi at stage 2.
16 weeks
Incidence of adverse events
Adverse events will be measured by the type and frequency (no events, 1-2 events, \>3 events) experienced by the elderly at home before and after the model trial.
16 weeks
Study Arms (2)
Intervention Group- Receiving intervention by educating, training and homevisit
EXPERIMENTALFor the intervention groups, planning will be done to provide education and training. Families will be given modules on Safety Culture in the Elderly and will also receive home visits to check and monitoring the condition of the elderly at home related to adverse events and the home environment.
Control group
NO INTERVENTIONThisi control group will only monitoring every 4 weeks by home visit. After 16 weeks, researchers will evaluate perceptions of the elderly's safety culture at home and adverse events at home
Interventions
For the intervention groups, planning will be done to provide education and training. Families will be given modules on Safety Culture in the Elderly. Materials provided about the safety of the elderly include changes in the elderly, the concept of safety in the elderly, the type of danger to the elderly, how to prevent harm in the elderly, the first handling in case of accidents, and the role of the family in the efforts of elderly safety. The material will be delivered by experts in elderly health and patient safety (professionals from health centers, social services, and academics). In addition to education and training, families will also receive home visits to check and monitoring the condition of the elderly at home related to adverse events and the home environment. Measuring will be done every 4 weeks by using a monitoring book.
Eligibility Criteria
You may not qualify if:
- family did not continue the study, elderly were hospitalized, and died during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Elderly
Bandung, West Java, Indonesia
Related Publications (1)
Solihin AH, Probosuseno, Effendy C. Evaluating a caregiver-focused safety culture model: Effects on caregivers' safety perception, older adults' quality of life, and the incidence of adverse events in Indonesia. Belitung Nurs J. 2025 Oct 5;11(5):637-647. doi: 10.33546/bnj.3650. eCollection 2025.
PMID: 41064570DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Invesigator
Study Record Dates
First Submitted
July 10, 2022
First Posted
August 4, 2022
Study Start
July 20, 2021
Primary Completion
November 1, 2022
Study Completion
December 1, 2022
Last Updated
August 4, 2022
Record last verified: 2022-08