Responding to people in danger. A project to develop and test a community pharmacy response service for people in danger from domestic abuse or feeling suicidal.
| ISRCTN | ISRCTN95063724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95063724 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 309018 |
| Protocol serial number | IRAS 309018, NIHR133132 |
| Sponsor | University of Lincoln |
| Funder | Health Services and Delivery Research Programme |
- Submission date
- 15/12/2021
- Registration date
- 15/09/2022
- Last edited
- 16/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The COVID-19 pandemic has increased the number of people feeling suicidal and has increased domestic abuse. Both situations are distressing and can be fatal. However, these deaths are preventable and harm can be minimised if people are able to access timely and appropriate help. Community pharmacies may be suitable places to access this help as they are highly accessible with long opening hours and no requirements for appointments. This study aims to co-develop and then test the feasibility of a community pharmacy response service for people in danger from either suicide or domestic abuse.
Who can participate?
Pharmacy staff aged 18 years or over
What does the study involve?
There are two stages to this project:
Stage 1 (service co-development): This will be achieved by one-to-one interviews with experts, lay focus groups and co-development workshops (with members of the public and pharmacy staff). The researchers will co-develop and refine the name, concept, design and resources for the new service. Resources will include developing a pharmacist clinical assessment and referral tool, and a training package for the pharmacy staff.
Stage 2 (feasibility test in pharmacies): Following its development, the service will be tested for feasibility in 12 pharmacies. Eight will deliver the service and four will not. The researchers will train three pharmacy staff members from each of the eight pharmacies and collect data on service usage and the number of referrals made. Focus groups will be held to understand how pharmacy staff felt about delivering the service.
To understand public acceptability, the researchers will interview pharmacy customers and do a public survey. A final workshop with all will be arranged with all pharmacy staff, research team and the public and patient advisory panel.
What are the possible benefits and risks of participating?
The researchers cannot promise that the study will help participants themselves but the information from the study will help them to better understand how best to develop the pharmacy response service and to deliver this in practice.
The involvement in the project activities may cause inconvenience. The researchers will seek to minimise this by arranging these at a time that is convenient to most participants. As mentioned, talking about people in danger can be sensitive and could lead to participants becoming upset. Participants are asked to carefully consider these issues before deciding whether to take part. The researchers will hold all activities in a sensitive way and use an appreciative approach where all views are respected and valued.
Where is the study run from?
University of Lincoln (UK)
When is the study starting and how long is it expected to run for?
October 2021 to September 2023
Who is funding the study?
National Institute for Health Research (NIHR) Health Services and Delivery Research (HS&DR) programme (UK)
Who is the main contact?
Dr Josie Solomon
jsolomon@lincoln.ac.uk
Contact information
Scientific
School of Pharmacy
University of Lincoln
Brayford Way
Lincoln
LN6 7TS
United Kingdom
 ORCID ID |
0000-0003-1022-5759 |
|---|---|
| Phone | +44 1522 882000 |
| lifeguardpharmacy@lincoln.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Intervention co-development followed by randomized feasibility trial and evaluation |
| Secondary study design | Feasibility trial |
| Participant information sheet | 40821_PIS_V1.0_14Dec21.pdf |
| Scientific title | Responding to people in danger. A development and feasibility study to co-develop a community pharmacy response service for domestic abuse and suicidal ideation. |
| Study objectives | How feasible and acceptable is a co-produced community pharmacy response intervention for identifying and referring people in danger from suicidal ideation or domestic abuse? |
| Ethics approval(s) | Approved 04/05/2022, North West - Preston Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8233; preston.rec@hra.nhs.uk), ref: 22/NW/0016 |
| Health condition(s) or problem(s) studied | Suicide prevention and prevention of domestic abuse |
| Intervention | Current intervention as of 16/01/2023: This study will co-develop and evaluate the feasibility of an intervention in community pharmacies to respond to people in danger from either suicidal ideation or domestic abuse, with parallel engagement of a steering group and PPI panel. Development: Qualitative interviews will be held with eight representatives from referral organisations, followed by two lay focus groups and three co-production workshops with eight lay people and four pharmacy staff in each workshop. Feasibility: Purposive sampling will be used to recruit 12 pharmacies, based on rural or urban location, sole pharmacy or co-located. The pharmacies will then be randomised to give eight intervention and four control pharmacies. A minimum of three members of staff from each intervention pharmacy will be trained, followed by implementation of the intervention for 6 months. Service use and referral data will be collected from the intervention pharmacies and data on requests for assistance from control pharmacies over 6 months. Public acceptability will be measured using an e-survey and interviews with three customers per intervention pharmacy. A feasibility workshop will be held with the 24 intervention participants, steering, and PPI group. _____ Previous intervention: This study will co-develop and evaluate the feasibility of an intervention in community pharmacies to respond to people in danger from either suicidal ideation or domestic abuse, with parallel engagement of a steering group and PPI panel. Development: Qualitative interviews will be held with eight representatives from referral organisations, followed by two lay focus groups and three co-production workshops with eight lay people and four pharmacy staff in each workshop. Feasibility: Purposive sampling will be used to recruit 12 pharmacies, based on rural or urban location, sole pharmacy or co-located. The pharmacies will then be randomised to give eight intervention and four control pharmacies. Three members of staff from each intervention pharmacy will be trained, followed by implementation of the intervention for 6 months. Service use and referral data will be collected from the intervention pharmacies and data on requests for assistance from control pharmacies over 6 months. Public acceptability will be measured using an e-survey and interviews with three customers per intervention pharmacy. A feasibility workshop will be held with the 24 intervention participants, steering, and PPI group. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The number of community pharmacy consultations for people enquiring about or seeking support for domestic abuse or suicidal ideation, measured using pharmacy records of numbers of requests at monthly timepoints during the intervention |
| Key secondary outcome measure(s) |
1. The levels of severity of danger that clients present with, assessed and measured using a triage and referral grid in the consultation that classifies the categories of domestic abuse and suicidal ideation at three levels of risk: signs of concern, active concern and urgent concern. Measured at monthly timepoints during the intervention. |
| Completion date | 30/09/2023 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 24 |
| Key inclusion criteria | 1. Pharmacy members of staff 2. Aged 18 years or over 3. Employed by an intervention pharmacy |
| Key exclusion criteria | Locum or temporary staff |
| Date of first enrolment | 30/09/2022 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Lincoln
LN6 7TS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The researchers do not expect to make their qualitative data from the co-development or process evaluation phases available, due to its sensitivity and the difficulties of anonymisation. They will provide a full data sharing plan for the quantitative feasibility trial data at a later date, once they have assessed the dataset and identified whether it can be safely or usefully shared. They will share anonymised questionnaire data from the customer survey on request, available via email from Jsolomon@lincoln.ac.uk, with accompanying metadata. This will become available 12 months after the study end date, to allow time for publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version 1.0 | 14/12/2021 | 16/12/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.1 | 12/11/2022 | 16/01/2023 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 40821_PIS_V1.0_14Dec21.pdf
- Participant information sheet
- ISRCTN95063724_Protocol_v1.1_12Nov2022.pdf
- Protocol file
Editorial Notes
16/01/2023: The following changes have been made:
1. Protocol file uploaded.
2. The trial website has been added.
3. The intervention has been changed.
16/12/2021: Trial's existence confirmed by the NIHR.
