Women’s prisons: how can we improve primary care for women with severe mental illness?
| ISRCTN | ISRCTN10216673 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10216673 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 342813 |
| Protocol serial number | NIHR206780 |
| Sponsor | Durham University |
| Funder | National Institute for Health and Care Research |
- Submission date
- 13/06/2024
- Registration date
- 28/06/2024
- Last edited
- 04/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
We do not know whether women with serious mental illness (SMI) in prison access primary care services. We would like to understand more about this. Hardly any evidence exists about how imprisoned women with SMI use primary care services. These services include general practice, dentists, eye health (opticians) and pharmacists. We want to find out how such services meet their healthcare needs and how these experiences are racially differentiated.
Who can participate?
1. Primary care practitioners who provide such services in women’s prisons
2. Imprisoned women with a history of SMI aged over 18 years
3. Health and non-clinical prison staff with experience of working with imprisoned women with SMI
What does the study involve?
In part one the researchers will ask primary care practitioners over the telephone what range of primary care services are delivered in prison and describe what is working well for imprisoned women with SMI.
In part two the researchers will ask small groups of imprisoned women with SMI from a range of ethnic groups about possible inequalities in the provision of physical and mental health services offered to them.
In part three the researchers will talk to other staff in the prison in small groups about any barriers to providing primary care for women with SMI both within prison and following release.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Durham University (UK)
When is the study starting and how long is it expected to run for?
November 2023 to March 2026
Who is funding the study?
National Institute for Health and Care Research (UK)
Who is the main contact?
Prof. Tammi Walker, tammi.walker@durham.ac.uk
Contact information
Public, Scientific, Principal investigator
Durham University
Department of Psychology
Upper Mountjoy
South Rd
Durham
DH1 3LE
United Kingdom
 ORCID ID |
0000-0001-7446-8771 |
|---|---|
| Phone | +44 (0)191 33 43404 |
| tammi.walker@durham.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Qualitative research design with interviews and focus groups |
| Secondary study design | Qualitative research design with interviews and focus groups |
| Study type | Participant information sheet |
| Scientific title | Improving primary care services for imprisoned women with severe mental illness (IP-SIS) |
| Study acronym | IP-SIS |
| Study objectives | Aims: 1. To explore the range of primary care services delivered to imprisoned women with serious mental illness (SMI) in England and describe what is working well. 2. To explore the treatment experiences and preferences of imprisoned women with SMI. 3. To describe preparations for transition from prison to mainstream primary care. Objectives: O1. To describe experiences of imprisoned women with SMI of primary care services across women’s prisons in England. O2. To explore perspectives of prison primary care practitioners and other prison staff on the delivery of primary care services in prisons. O3. To explore potential inequalities in the provision of physical and mental health services for imprisoned women with SMI across ethnic groups in women’s prisons. O4. To develop a culturally and racially sensitive framework for understanding of the barriers and facilitators to providing primary care for women with SMI both within prison and following release. |
| Ethics approval(s) |
Approved 25/03/2025, Nottingham 2 REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8009; nottingham2.rec@hra.nhs.uk), ref: 24/EM/0286 |
| Health condition(s) or problem(s) studied | Improving primary care services for imprisoned women with serious mental illness |
| Intervention | The researchers will apply a qualitative research design over an 18-month period using semi-structured telephone/online interviews, focus groups and consensus groups in six women's prisons. Purposive sampling will be used throughout the project to ensure that the perspectives of women and staff from a range of different prison groupings are included. Study sites will be women's prisons in England (there are none in Wales). The researchers will ask people in three groups to volunteer to take part. 1. Primary care practitioners (GPs and nurses) who provide healthcare services in prisons. 2. Imprisoned women with SMI from diverse ethnic backgrounds. 3. Clinical and non-clinical prison staff with experience of working with imprisoned women with SMI. |
| Intervention type | Other |
| Primary outcome measure(s) |
Participants’ perspectives and experiences of primary care services provided in women’s prisons, with a focus on women with severe mental illness in racially minoritised groups. Qualitative feedback and data from participants will be recorded and analysed using framework analysis. Measured at a single timepoint. |
| Key secondary outcome measure(s) |
The potential inequalities in the provision of primary care services in women's prisons across ethnic groups. Qualitative feedback and data from participants will be analysed using framework analysis and a culturally and racially sensitive framework will be developed to understand the barriers and facilitators to providing primary care for women with severe mental illness in prison and following release. Measured at a single timepoint. |
| Completion date | 02/03/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Health professional, Employee, Service user, Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 125 |
| Key inclusion criteria | Phase 1: Primary care practitioners who work in female prisons 1. Aged 18+ years 2. Qualified primary care practitioners who have worked in a female prison for at least 3 months Phase 2: Imprisoned women with SMI 1. Aged 18+ years 2. Have the mental capacity to give informed consent (discussion through Safer Custody Team) Phase 3: Health and non-clinical prison staff 1. Aged 18+ years 2. Qualified or non-qualified prison staff who have worked in a female prison for at least 3 months |
| Key exclusion criteria | Phase 1: Primary care practitioners who work in female prisons 1. Under the age of 18 years 2. Qualified primary care practitioners who have not worked in a female prison for at least 3 months Phase 2: Imprisoned women with SMI 1. Under the age of 18 years 2. Unable to provide informed consent 3. Pose a significant risk to self and/or others Phase 3: Health and non-clinical prison staff 1. Under the age of 18 years 2. Qualified or non-qualified prison staff who have not worked in a female prison for at least 3 months |
| Date of first enrolment | 17/02/2025 |
| Date of final enrolment | 01/01/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St Georges Hospital
Corporation Street
Stafford
ST16 3SR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available due to sensitive nature of the data and HMPPS governance issues. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 28/02/2025 | 03/04/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/04/2025: The secondary identifying number was changed from NIHR205337 to NIHR206780.
03/04/2025: The following changes were made to the trial record:
1. Publication reference added.
2. The ethics approval was added.
12/02/2025: The recruitment start date was changed from 01/03/2025 to 17/02/2025.
07/02/2025: The recruitment start date was changed from 01/02/2025 to 01/03/2025.
08/01/2025: The recruitment start date was changed from 01/12/2024 to 01/02/2025.
05/11/2024: The recruitment start date was changed from 01/11/2024 to 01/12/2024.
09/10/2024: The recruitment start date was changed from 01/10/2024 to 01/11/2024.
03/07/2024: The recruitment start date was changed from 01/09/2024 to 01/10/2024.
13/06/2024: Study's existence confirmed by the NIHR.
