Safety and autonomy for everyone at Home. Understanding safety, risks and harm-benefit balances arising from home-based care.
| ISRCTN | ISRCTN16548878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16548878 |
| IRAS number | 358127 |
| Secondary identifying numbers | NIHR 161525 |
- Submission date
- 01/09/2025
- Registration date
- 04/09/2025
- Last edited
- 02/09/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study is looking at how to make care provided in people’s homes safer. While home-based care is important, we don’t yet fully understand what “good” care looks like or how to make sure it’s safe. The research team wants to learn more about the risks and benefits of care at home, and how to improve it. They’ll do this by reviewing existing research, looking at safety reports, and speaking with both professionals and people who receive care.
Who can participate?
The study is inviting two main groups to take part:
-Professionals involved in planning, managing, or delivering home-based care (such as care workers, managers, and organisations).
-People who receive care at home, their family members, and unpaid or paid carers. This includes people who used to receive care at home but now live in care homes.
What does the study involve?
Participants will be asked to take part in either a focus group or an interview:
-Professionals may join a one-hour focus group or a one-on-one interview.
-People receiving care, their families, or carers will be invited to take part in an interview to share their experiences and views.
What are the possible benefits and risks of participating?
Taking part could help improve the safety of home-based care for others in the future. There are no expected risks, but some conversations may touch on sensitive or emotional topics. The research team will handle these discussions with care and respect.
Where is the study run from?
Cardiff University (UK)
When is the study starting and how long is it expected to run for?
March 2025 to February 2027.
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Joy McFadzean, SAFEATHOME@Cardiff.ac.uk
Contact information
Principal Investigator
Cardiff University
Cardiff
CF14 4YS
United Kingdom
 ORCID ID |
0000-0002-7580-7699 |
|---|---|
| Carson-stevensap@cardiff.ac.uk |
Public
Swansea University
Swansea
SA2 8PP
United Kingdom
| ORCID ID |
0000-0002-3107-3945 |
|---|---|
| D.J.Morgan@Swansea.ac.uk |
Scientific
Cardiff University
Cardiff
CF14 4YS
United Kingdom
| ORCID ID |
0000-0001-9766-2681 |
|---|---|
| McFadzeanJ@Cardiff.ac.uk |
Study information
| Study design | Mixed- methods including observational (focus groups and interviews) a Realist synthesis of the literature and a descriptive analysis of safety notifications |
|---|---|
| Primary study design | Observational |
| Secondary study design | Mixed-methods |
| Study setting(s) | Care home, Charity/Voluntary sector, Community, Home, Internet/virtual, Telephone, Workplace |
| Study type | Quality of life, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | SAFE@HOME: Safety and Autonomy For Everyone At home. Understanding safety, risks and harm-benefit balances arising from home-based care |
| Study acronym | SAFE@HOME |
| Study objectives | To understand safety, risks and harm-benefit balances arising from home-based care |
| Ethics approval(s) |
1. Submitted 11/08/2025, Wales REC Research Ethics Committee (REC) 7 (Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2922941107; Wales.REC7@wales.nhs.uk), ref: 25/WA/0256 2. Approved 08/08/2025, Cardiff University School of Medicine Research Ethics Committee (Cardiff University, Heath Park, Cardiff, CF14 4YS, United Kingdom; -; Medic_REC@Cardiff.ac.uk), ref: 25/38 |
| Health condition(s) or problem(s) studied | Care received at home, focusing on older adults (>60 years old). |
| Intervention | This is an observational study, which will carry out a realist synthesis of the existing literature to understand safety within a home-based care context, analyse up to 6000 safety notifications from social care, and carry out focus groups and interviews with participants. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Concepts and constructs used to define safe home-based care are measured using realist synthesis of published literature 2. Characteristics of safety incidents in home-based care are measured using analysis of up to 6000 safety notifications from social care data sources 3. Professional stakeholder views on enablers and constraints to safe home-based care are measured using qualitative focus groups and interviews 4. Organisational factors influencing safe outcomes in home-based care are measured using qualitative focus groups and interviews with care providers and related organisations 5. Experiences and safety concerns of care recipients and their families/informal caregivers are measured using qualitative interviews 6. Multivoiced conceptualisation of safety in home-based care is developed using realist methodology combining synthesis of literature, quantitative summaries of safety notifications, and qualitative data from interviews and focus groups 7. Additional stakeholder perspectives on what matters to people receiving care will be collected at three stakeholder events |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/03/2025 |
| Completion date | 28/02/2027 |
Eligibility
| Participant type(s) | Health professional, Carer, Employee, Service user, Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | We have planned for up to 80 participants for the focus groups, and up to 70 interviews (10 within WP2b and 60 within WP3) |
| Key inclusion criteria | Work Package 2b (focus groups and interviews with professional stakeholders): 1. Adults (over the age of 18 years) 2. Stakeholders responsible for the planning, management or delivery of home-based care from across the four UK nation, plus perspectives from community teams and leaders. 3. Participant is willing and able to give informed consent Work Package 3 (interviews with people who receive care, carers, theirs families and personal consultees): 1. Participant is willing and able to give informed consent 2. Servicer users over the age of 60 years old, who currently receives home-based care, or used to receive home-based care and now resides within a care home or paid/unpaid carers. This group will also include family members or a 'personal consultee' who can discuss home-based care in lieu of people who receive home-based care but do not have the capacity to consent to participate. 3. Reside within Wales |
| Key exclusion criteria | Work Package 2b (professional stakeholders and interviews) 1. If participants already sit within our oversight groups (e.g., Steering committee or Research Management group) 2. If they cannot give informed consent to participate Work Package 3 (interviews with service users/families/personal consultees or unpaid/paid carers): 1. If they cannot give informed consent to participate within the study |
| Date of first enrolment | 01/10/2025 |
| Date of final enrolment | 28/02/2027 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
Cardiff
CF10 3AT
United Kingdom
Sponsor information
University/education
Heath Park
Cardiff
CF14 4YS
Wales
United Kingdom
| RichardsNA2@Cardiff.ac.uk | |
| Website | http://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | We plan to share out findings within our NIHR final study report, peer-reviewed journals and in public-facing documents. |
| IPD sharing plan | Anonymised interview transcripts generated during the current study will be stored within a non-publicly available repository via Cardiff University. Details to be shared at a later date and subject to participant consent. |
Editorial Notes
02/09/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
