Women’s prisons: how can we improve primary care for women with severe mental illness?

ISRCTN ISRCTN10216673
DOI https://doi.org/10.1186/ISRCTN10216673
IRAS number 342813
Secondary identifying numbers NIHR206780
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Prof Tammi Walker
Public, Scientific, Principal Investigator

Durham University
Department of Psychology
Upper Mountjoy
South Rd
Durham
DH1 3LE
United Kingdom

ORCiD logoORCID ID 0000-0001-7446-8771
Phone +44 (0)191 33 43404
Email tammi.walker@durham.ac.uk

Study information

Study designQualitative research design with interviews and focus groups
Primary study designObservational
Secondary study designQualitative research design with interviews and focus groups
Study setting(s)Prison/detention
Study typePrevention, Quality of life, Treatment
Participant information sheet Not available in web format please use contact details to request a participant information sheet
Scientific titleImproving primary care services for imprisoned women with severe mental illness (IP-SIS)
Study acronymIP-SIS
Study objectivesAims:
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) studiedImproving primary care services for imprisoned women with serious mental illness
InterventionThe 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 typeOther
Primary outcome measureParticipants’ 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.
Secondary outcome measuresThe 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.
Overall study start date17/11/2023
Completion date02/03/2026

Eligibility

Participant type(s)Healthy volunteer, Health professional, Employee, Service user, Other
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participantsPhase 1 (approx. n = 25); Phase 2 (approx. n = 40); Phase 3 (approx. n = 60)
Key inclusion criteriaPhase 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 criteriaPhase 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 enrolment17/02/2025
Date of final enrolment01/01/2026

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Midlands Partnership NHS Foundation Trust
Trust Headquarters
St Georges Hospital
Corporation Street
Stafford
ST16 3SR
United Kingdom

Sponsor information

Durham University
University/education

Research & Innovation Services
The Palatine Centre
Stockton Road
Durham
DH1 3LE
England
United Kingdom

Phone +44 (0)300 790 7000
Email psychology.research@durham.ac.uk
Website https://www.durham.ac.uk/research/
ROR logo "ROR" https://ror.org/01v29qb04

Funders

Funder type

Government

National Institute for Health and Care Research
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 date01/06/2026
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe researchers will disseminate findings through lay research summaries, prison dissemination events, publications in peer-reviewed journals, at least one conference presentation, and social media. The publication and dissemination activity will be guided by the Public Advisory Panel (PAP).
IPD sharing planThe 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

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.