PHOENIx community pharmacy trial
| ISRCTN | ISRCTN88146807 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88146807 |
| IRAS number | 309760 |
| Secondary identifying numbers | CPMS 52971, IRAS 309760, RG_20-123123 |
- Submission date
- 16/06/2022
- Registration date
- 18/07/2022
- Last edited
- 21/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Persons experiencing homelessness are among the most marginalised, destitute and vulnerable groups in the UK. Despite most homeless persons being aged in their late 30s, most have seven different health problems. This is on a par with people aged 85 years old living in their own homes. Most homeless persons die before they reach 43 years of age and many deaths are preventable if they receive care but homeless persons find it difficult, amidst all their competing needs, to seek help until it is too late.
Most health services operate by appointment, in buildings, whereas homeless persons are displaced and live on the streets, in soup kitchens and temporary accommodation, far from their GP, addictions team and/or mental health team, leading to fragmented care. Health conditions often remain underdiagnosed, and untreated and they drop out of care unintentionally, because of their chaotic circumstances. Drug overdose, a repeated cycle of homelessness, and high use of emergency departments are common. There is not enough evidence for us to make informed changes to health services for people who are homeless, so we plan to test a new approach involving pharmacists and third-sector homeless charity workers collaborating, in city centre community pharmacies.
Community pharmacies are often used by homeless persons daily for services such as their prescriptions and treatment for problem drug use. There is no need for appointments and they are located in city centres, where people who are homeless call home. However, the clinical skills and knowledge of pharmacists including prescribing roles (they can prescribe medicines) have not been formally tested in community pharmacies, caring for homeless persons. Charities help people who are homeless, by acting as advocates, helping with benefits, housing, shelter, food and clothing. Street-based charities have outreach workers with lived experience of homelessness, who develop strong relationships and trust with people who are homeless. They operate separately and do not formally share information with the health service leading to missed opportunities.
Who can participate?
Homeless adults who are service users of one of the designated community pharmacies
What does the study involve?
In this study, we are testing a new model of care that offers integrated health and social care support for people experiencing homelessness. A pharmacist prescriber will work in partnership with a third-sector charity worker, in community pharmacies. Development work shows our intervention is received well by patients, in Glasgow (Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx -PHOENIx) where the pharmacist deals with health and charity worker deals with housing, benefits, and social prescribing. It helps people get onto treatments for their physical, and mental health and addictions. Now we would like to see whether it works by testing the approach in a controlled way, and see if it is value for money, by running a miniature controlled trial. This will prepare us for a much bigger trial that will give us conclusive results, influence policy decisions, roll out the intervention across the UK, and improve the health of people who are homeless, which is long overdue.
We aim to share our findings with the homeless persons and staff, in medical journals, and in national scientific meetings and will make these available through websites of professional societies, government bodies and homeless charities. Our charity co-applicant partners will disseminate in their networks.
What are the possible benefits and risks of participating?
In the future, this study could help improve care for people who are experiencing homelessness. Participants in the intervention group will receive additional follow-up care, which they may not normally receive. Information we get from this study will help us plan a larger study to test how effective the PHOENIx intervention is, and whether it improves the quality of life.
We do not anticipate any disadvantages to participants taking part. They will need to give their time to participate in the study including completing questionnaires when they join the study and at three and six months. There is a potential that the interview may be tiring or the topics may be challenging. However, participants will be able to take a break or stop the interview at any point. If the researcher becomes concerned for the participant's wellbeing during the interview, they will discuss their concerns with you and work in partnership with the participant to determine the best course of action. If necessary, the researcher may contact participants’ GPs if they are concerned about participant wellbeing. Participants will be informed that taking part in the study and any answers they give in questionnaires or interviews will not affect their treatment in the NHS, their care or their legal rights.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
March 2022 to January 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Sarah Tearne, s.clarke.2@bham.ac.uk
Contact information
Principal Investigator
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 2538 |
|---|---|
| v.paudyal@bham.ac.uk |
Public
Birmingham Clinical Trials Unit
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 415 9100 |
|---|---|
| s.clarke.2@bham.ac.uk |
Principal Investigator
Pharmacy and Prescribing Support Unit
NHS Glasgow and Clyde
Glasgow
G76 7AT
United Kingdom
 ORCID ID |
0000-0002-6440-9089 |
|---|---|
| Phone | +44 (0)7971827565 |
| Richard.Lowrie@ggc.scot.nhs.uk |
Study information
| Study design | Randomized multicentre open-label parallel-group external pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community, Pharmacy |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx (PHOENIx) community pharmacy-based pilot randomised controlled trial |
| Study acronym | PHOENIx community pharmacy |
| Study hypothesis | To test the hypothesis that a pilot study of the PHOENIx intervention shows merit in progression to a definitive randomised controlled trial |
| Ethics approval(s) | Approved 19/07/2022, East Midlands - Leicester South Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 104 8193, +44 (0)207 104 8177; leicestersouth.rec@hra.nhs.uk), ref: 22/EM/0119 |
| Condition | Persons experiencing homelessness |
| Intervention | In addition to usual care, the PHOENIx team (pharmacist independent prescriber in partnership with a third sector charity worker) will assess the participants’ physical, mental and addictions health, housing, benefits and social activities during a consultation in the community pharmacy. Taking approximately one hour, face to face (with full personal protective equipment), the PHOENIx team will record the participant’s priorities, and going at the participant’s pace, will assess, treat, prescribe, and refer to other health and social care teams. |
| Intervention type | Mixed |
| Primary outcome measure | 1. The randomisation process and recruitment rate measured by the numbers invited to participate, numbers recruited at baseline 2. Retention of those remaining in the trial at 3 months and 6 months follow up 3. Adherence to the intervention measured by the proportion of participants attending the intervention at planned visits 4. Proportion of participants with patient-reported outcomes completed measured by the number of participants who complete the questionnaire booklet at planned visits 5. Proportion of participants with routinely collected Emergency Department visits and mortality data available at 6 months |
| Secondary outcome measures | Clinical measures: 1. Number and cause of Emergency Department visits measured by patient-reported and routinely collected data at 3 and 6 months 2. Number and cause of primary care general practice visits measured by patient-reported and routinely collected data at 3 and 6 months 3. Mortality measured by routinely collected data at 6 months 4. Medication changes (prescribed) and taken (in the case of opioid substitution therapy where supervised) measured through patient-reported and routinely collected data at 3 and 6 months 5. Number and cause of hospitalisation measured by patient-reported and routinely collected data at 3 and 6 months 6. Intervention acceptability measured by qualitative interviews with patients, the intervention delivery team and stakeholders as an ongoing process evaluation 7. Generic health-related quality of life score and health thermometer score measured by EQ-5D-5L at 3 months and 6 months 8. Frailty measured by Fried’s adapted frailty phenotype at 3 months and 6 months 9. Respiratory health measured by Peak Expiratory Flow Rate, MRC Dyspnoea scale and COPD Assessment Test (CAT) at 3 months and 6 months 10. Blood pressure measured by blood pressure monitors at 3 months and 6 months Addiction measures: 1. Number of participants experiencing drug overdoses not requiring an Emergency Department visit and the number of overdoses measured by patient-reported data at 3 months and 6 months 2. Number of participants (and number of times) referred to drug and alcohol services, rehab, mental health and GP, and the numbers attending subsequently measured by patient-reported and routinely collected data at 3 and 6 months 3. Numbers and time to commencement on opiate substitute treatment (OST)/benzodiazepine/heroin-assisted treatment and collecting ≥ 80% of daily doses measured by routinely collected data at 3 months and 6 months 4. Number of participants treated with and time to minimum therapeutic OST dose measured by routinely collected data at 3 months and 6 months 5. Dose of OST measured by routinely collected data at 3 months and 6 months 6. Number of missed appointments (with any team, including irregular discharges) and number of participants with missed appointments measured by routinely collected data at 3 months and 6 months 7. Number of persons and days in prison/criminal justice encounters measured by patient-reported data at 3 and 6 months Social measures: 1. Housing tenure including night shelters, emergency accommodation measured by self-reported data and those provided by the council or third sector, or care home at 3 months and 6 months 2. Level of debt as self-reported by patients at 3 months and 6 months 3. Criminal justice encounters as self-reported by patients at 3 months and 6 months |
| Overall study start date | 01/03/2022 |
| Overall study end date | 01/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Participant inclusion criteria | 1. Aged 18 years old and over 2. Experiencing homelessness including: 2.1. Rooflessness 2.2. Houselessness 2.3. Insecure or inadequate housing as per the ETHOS typology 2.4. Staying in homeless shelters 2.5. Rough sleeping 2.6. Staying in temporary accommodation, such as bed and breakfasts (B&Bs), hostels, squats; or that sofa surfing between family and friends’ houses 3. Attending or service users of one of the designated community pharmacies |
| Participant exclusion criteria | 1. Living in accommodation with 24-hour support which includes in-house medical care 2. Intoxicated or (in the opinion of the researcher) posing a safety risk to staff and lacking the capacity to consent |
| Recruitment start date | 21/07/2022 |
| Recruitment end date | 01/10/2022 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
50 Summer Hill Road
Birmingham
B1 3RB
United Kingdom
Sponsor information
University/education
Finance Office
Aston Webb
B Block Room 106
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)7814650003 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
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 | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. A final study report to be shared with the funder 2. The report will also be available on the study website 3. Pilot study results will be shared with relevant stakeholders with the aim of further engagement and support for the main study |
| IPD sharing plan | Requests for data generated during this study will be considered by the University of Birmingham Clinical Trials Unit (BCTU). Data will typically be available 6 months after the primary publication unless it is not possible to share the data (for example the trial results are to be used as part of a regulatory submission, and the release of the data is subject to the approval of a third party who withholds their consent, or BCTU is not the controller of the data). Only scientifically sound proposals from appropriately qualified Research Groups will be considered for data sharing. The request will be reviewed by the BCTU Data Sharing Committee in discussion with the clinical investigators (CIs) and, where appropriate (or in absence of the CIs) any of the following: the Trial Sponsor, the relevant Trial Management Group (TMG), and independent TOC. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 23/02/2023 | 24/02/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/10/2024 | 21/10/2024 | Yes | No |
Editorial Notes
21/10/2024: Publication reference added.
20/05/2024: The following changes were made:
1. Total final enrolment added.
2. The intention to publish date was changed from 01/12/2024 to 01/01/2025.
27/11/2023: Contact details updated.
24/11/2023: Contact details updated. Protocol/serial number added.
24/02/2023: Publication reference added.
07/12/2022: Ethics approval details added. The recruitment start date was changed from 21/07/2022 to 08/11/2022.
21/07/2022: A principal investigator contact has been updated.
19/07/2022: A scientific contact has been added.
05/07/2022: Trial's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
