WardSonar: a real-time measure of safety for mental health wards
| ISRCTN | ISRCTN14470430 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14470430 |
| IRAS number | 300833 |
| Secondary identifying numbers | IRAS 300833, CPMS 50821 |
- Submission date
- 07/01/2022
- Registration date
- 10/01/2022
- Last edited
- 03/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Evidence shows there are large numbers of safety issues on acute mental health wards, frequently involving violence and self-harm, associated with increased costs, physical and psychological harm. Safety data is currently only collected retrospectively and very little is collected from the service user perspective. This study aims to co-design with service users and staff a technological intervention that collects data about the perception of safety from service users, in order to support staff to anticipate and avoid developing incidents.
Stakeholder and lay input has informed the development of this project, specifically through discussions with service users and co-applicant representation. We will link to existing stakeholder groups hosted by Leeds and York Partnership NHS Foundation Trust to support the project via co-app with lived experience. The key outputs of the research will be a new intervention in the form of a licenced product to enable the collection of and response to real-time service user-generated safety data. The research will produce traditional and non-traditional publications in a variety of media. Dissemination will target key stakeholders: mental health service providers, commissioners, regulators, practitioners, policy makers, and academic researchers and make effective use of social media. We will publish in high-impact open access academic journals and present and discuss our findings at conferences to a wide range of practitioners, academics, and service users. We will also devise and host a digitally supported dissemination event and invite representation from all stakeholders. The resulting product has the potential to improve safety and well-being for service users and staff on acute mental health wards, a key concern of the CQC and an NHS priority.
Who can participate?
Service users aged 16 years or above, who are a current inpatient of a mental health ward
What does the study involve?
The project has two phases and uses different methods during each phase. Phase 1 uses a co-design approach to developing the intervention, supported by an ‘environmental scan’ consisting of a scoping review and the collection and qualitative analysis of interview data. Phase 2 will be a mixed-methods process evaluation. A focused ethnography will explore how staff communicate and use safety data supported by interviews with service users and staff to further understand feasibility and acceptability. We will simultaneously collect routine data including incidents, NHS mental health safety thermometer (if available), workforce and ward occupancy. Measures relating to safety culture and ward atmosphere will be completed pre and post intervention, as well as real-time measures of these concepts on three occasions. The synthesis of these data will assess the impact of the intervention on outcome measures; enhanced understanding of feasibility and acceptability.
What are the possible benefits and risks of participating?
The information participants provide will help us develop our research which might lead to improved safety on wards. We hope participants will find the subject of the interview and sharing your views interesting. Depending on their experiences participants may find talking about them upsetting, if this is the case we will ensure participants are provided with sources of support.
Where is the study run from?
University of Leeds (UK)
When is the study starting and how long is it expected to run for?
January 2020 to December 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Prof John Baker, J.Baker@leeds.ac.uk
Contact information
Principal Investigator
School of Healthcare
University of Leeds
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
| Phone | +44 113 343 1271 |
|---|---|
| j.baker@leeds.ac.uk |
Study information
| Study design | Mixed methods process evaluation |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Developing a service user centred co-designed patient safety intervention for acute mental health wards: A mixed methods process evaluation |
| Study acronym | WardSonar |
| Study hypothesis | This project aims to co-design an intervention that improves patient safety on acute mental health wards through the collection of daily data about the perception of safety from service users to support staff in monitoring and improving the safety of the clinical environment. The intervention will be tested, and its’ feasibility and acceptability explored. To achieve these aims, we have the following objectives: 1. To co-design with service users and staff an intervention that will allow real-time monitoring of safety on acute mental health wards 2. To explore the feasibility and acceptability of capturing real-time feedback from service users about safety 3. To explore how staff use this information when reported during daily handovers (or other mechanisms) 4. To explore how the resulting data is related to existing quality and safety metrics 5. To explore how these data can be used longitudinally to promote safety |
| Ethics approval(s) | Approved 08/11/2021, East Midlands - Nottingham 2 Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 203 443 6294; nottingham2.rec@hra.nhs.uk), ref: 21/EM/0247 |
| Condition | Safety on mental health wards |
| Intervention | A mixed-methods process evaluation. A focused ethnography will explore how staff communicate and use safety data supported by interviews with service users and staff to further understand feasibility and acceptability. We will simultaneously collect routine data including incidents, NHS mental health safety thermometer (if available), workforce and ward occupancy. Measures relating to safety culture and ward atmosphere will be completed pre and post intervention, as well as real-time measures of these concepts on three occasions. The synthesis of these data will assess the impact of the intervention on outcome measures; enhanced understanding of feasibility and acceptability. The digital intervention consists of up to four discrete ‘products’: a service user recording interface to collect data; healthcare staff dashboard for data analysis; a ward interface for public consumption; an Application Program Interface (API). The primary tool asks services users to answer a series of questions about how safe they feel recorded on a hand held tablet. Data will be recorded in real-time and sent to an API for data processing. The dashboard will be the main interface used by staff to view data submitted by service users. It will primarily be accessed in specific, authorised locations, such as the ward office, and provide real-time snapshot data and greater informational insights through the use of interactive data visualisations. A simple ward interface may be created (subject to co-design) to communicate a subset of outcome measures for public consumption. |
| Intervention type | Behavioural |
| Primary outcome measure | Quantitative evaluation of the ‘effect’ of the intervention on patient safety: 1. Continuous routine safety data (incidents, NHS mental health safety thermometer (monthly), workforce data, admissions/discharges, and ward occupancy and acuity) 2. Standard measures of culture and ward atmosphere (measures from the Agency for Healthcare Research and Quality (AHRQ), Hospital Survey on Patient Safety Culture (HSOPC), staff perceptions of ‘ward atmosphere’ using the EssenCES scale), pre and post intervention for each participating ward |
| Secondary outcome measures | Qualitative evaluation: Undertake a focused ethnography to explore the use of the intervention across a variety of wards and organisational settings. This combination of data will support an exploration of the intervention in terms of its’ use within each context, the challenges of engaging with the intervention, unintended consequences (positive and negative, and how these are mitigated), as well as an understanding of the likely requirements for a future trial design (outcomes, challenges, supporting factors etc). This will be presented as a case study for each ward. |
| Overall study start date | 01/01/2020 |
| Overall study end date | 30/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 6 wards, all patients per ward (approx 120 patients) and all members of the MDT. |
| Participant inclusion criteria | 1. Service user aged over 16 years 2. Current inpatient of a mental health ward 3. Capacity to consent to participate in research 4. Able to communicate in spoken English |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 10/01/2022 |
| Recruitment end date | 01/10/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Thorpe Park
Leeds
LS15 8ZB
United Kingdom
Heights Lane
Bradford
BD9 6DP
United Kingdom
Sponsor information
University/education
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
| Phone | +44 (0)113 2431751 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/12/2023 |
|---|---|
| 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 | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/05/2024 | 28/05/2024 | Yes | No | |
| Results article | Service-user patient safety perceptions, incidents and subsequent contagion | 28/11/2024 | 03/12/2024 | Yes | No |
Editorial Notes
03/12/2024: Publication reference added.
28/05/2024: Publication reference added.
01/02/2022: Internal review.
07/01/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
