The effects of helping and supporting an adult who experienced harm in the NHS and/or social care
| ISRCTN | ISRCTN16227158 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16227158 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | University of Oxford Ethics MS IDREC 674605, NIHR206117 |
| Sponsor | University of Oxford |
| Funder | National Institute for Health and Care Research |
- Submission date
- 22/08/2025
- Registration date
- 06/11/2025
- Last edited
- 06/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Involving carers (family or close friends) in the aftermath of physical or psychological harm in NHS or adult social care settings is important. Such events can have a negative effect on carers’ health and wellbeing. These effects can be direct or indirect, due to increased intensity or scope of caring after the harm. They often also play a vital role in supporting decisions and taking action after harm (e.g. whether to make a complaint or pursue litigation). Carers often adopt the important role of primary representative and decision-maker in the aftermath of harm, especially where the person harmed cannot speak for themselves.
The project will explore the carers' perspectives when someone (who they provide care for) has been physically and/or psychologically harmed in the NHS or adult social care settings. The study will find out how carers experience and are impacted by harm, what support needs they have, and the support they give their loved one (e.g., making complaints) after harm.
There has been little research on carers’ insights into harm. This study seeks to address this gap. Understanding carers’ perspectives will be used to develop recommendations for policy and practice designed to improve carers’ experiences and support health and wellbeing after harm.
Who can participate?
Adults (18 years or older) who provide care and support to a family member or close friend who was harmed in the NHS or social care in England. The harm needs to have happened in the last 5 years. Participants need to be able to participate in an interview (reasonable adaptations can be made with language and disability support).
What does the study involve?
One-to-one interviews will be conducted with up to 30 carers of people, who have experienced physical or psychological harm in the NHS or adult social care settings. The researchers will analyse the interviews to understand carers’ experiences, what effect it had on them, and what helped (or could have helped) in the aftermath of harm. They will also develop recommendations.
What are the possible benefits and risks of participating?
There are no immediate benefits to carers who take part, but some people find it helpful to reflect on their experiences and talk about them. For some people, however, it may be upsetting to recall and share experiences of supporting a family member or close friend who was harmed. The researchers will be attentive to any potential upset or distress, and if needed, will stop the interview. Details of who can give any further support (if needed after the interview) will be given.
Where is the study run from?
The study is run by researchers from the University of Oxford and the University of Kent, as part of the programme of work by the National Institute of Health Research Quality Safety and Outcomes Policy Research Unit (NIHR QSO PRU)
When is the study starting and how long is it expected to run for?
May 2024 to April 2026
Who is funding the study?
This project is funded by the National Institute of Health and Care Research (NIHR) through the Quality, Safety and Outcomes of Health and Social Care Policy Research Unit (QSO-PRU) (ref: NIHR206117)
Who is the main contact?
1. Dr Siabhainn Russell, siabhainn.russell@ndph.ox.ac.uk
2. Dr Stacey Rand, S.E.Rand@kent.ac.uk
Contact information
Public, Scientific, Principal investigator
Nuffield Department of Population Health
Richard Doll Building
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
 ORCID ID |
0000-0002-0076-5981 |
|---|---|
| Phone | +44 (0)1865 289428 |
| michele.peters@dph.ox.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Qualitative interview study |
| Secondary study design | Qualitative interview study |
| Study type | Participant information sheet |
| Scientific title | Experiences, outcomes and actions of family or friends (“carers”) when someone is harmed in the NHS or social care |
| Study objectives | To explore the perspectives of family or close friends’ (“carers”) when someone (who they provide care for) has been physically and/or psychologically harmed in the NHS or adult social care settings. The study aims to understand their experience and effects of harm, their support needs and the support they give their loved one (e.g., making complaints) after harm. |
| Ethics approval(s) |
Approved 08/10/2025, Medical Sciences Interdivisional Research Ethics Committee (MS IDREC) University of Oxford (Boundary Brook House, Churchill Drive, Headington, Oxford, OX3 7GB, United Kingdom; +44 (0)1865 616577; ethics@medsci.ox.ac.uk), ref: 674605 |
| Health condition(s) or problem(s) studied | Carer experiences (e.g. unmet need) and outcomes (e.g. quality of life) when they are supporting a family member or friend (with any type of physical and/or mental health problems) who was harmed in the NHS or social care |
| Intervention | One-to-one interviews will be conducted with up to 30 carers of people, who have experienced physical or psychological harm in the NHS or adult social care settings. Researchers will analyse the interviews to understand carers’ experiences, what effect it had on them, and what helped (or could have helped) in the aftermath of harm. They will also develop recommendations. |
| Intervention type | Other |
| Primary outcome measure(s) |
The experiences and outcomes of unpaid carer who help and support an adult with long-term health problems who experienced harm in the NHS and/or social care. Interviews will explore the impact of the harm on the carer, their actions after harm, and any support needs they have. Method: Qualitative one-to-one interview (a single interview) that will be analysed by thematic analysis. |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 01/04/2026 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. A family member or close friend, who provides or provided help, care or support to an adult (aged 18 years or older) due to their care and support needs (“carers”), where the adult experienced harm in the NHS or Adult Social Care contexts in the last 5 years 2. Aged 18 years or older at the time of the harm 3. Able to participate in an interview. Reasonable support and adaptations can be made (e.g. language or disability support) 4. Able to give informed consent to participate in the study 5. Living in England |
| Key exclusion criteria | 1. The harm was experienced outside of England – whether one of the other UK nations or another country 2. The harm was experienced in private healthcare settings, outside of NHS care 3. Aged under 18 years (now or at the time when the harm occurred) 4. Unable to communicate in English, even with support or adaptations |
| Date of first enrolment | 06/10/2025 |
| Date of final enrolment | 15/02/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets (anonymised interview transcripts) generated and analysed from this study will be available upon request from the Principal Investigator Dr Michele Peters (michele.peters@dph.ox.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/10/2025: Trial's existence confirmed by Medical Sciences Interdivisional Research Ethics Committee (MS IDREC) University of Oxford.
