Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx (PHOENIx) after drug overdose for people experiencing homelessness

ISRCTN	ISRCTN10585019
DOI	https://doi.org/10.1186/ISRCTN10585019
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	286329
Protocol serial number	IRAS 286329
Sponsor	NHS Greater Glasgow and Clyde
Funder	The Scottish Government (Drug Deaths Task Force) (UK)

Submission date: 16/11/2020
Registration date: 05/01/2021
Last edited: 13/02/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
People who are homeless often have problem drug use which leads to drug overdoses. These can be either fatal or non-fatal. Non-fatal overdoses are picked up on the street, homeless accommodation, Emergency Departments and lots of other places, mostly in and around Glasgow city centre. Glasgow has a particular problem with drug use and overdoses and homelessness. People who are homeless are generally very unwell, with drug addiction being one of many problems.
Over the past 7 years a team called the PHOENIx (Pharmacy Homeless Outreach Engagement Non medical Independent prescribing Rx) comprising NHS pharmacists working in pairs with Simon Community Scotland workers, have met people who are homeless and offered an assessment of their health, drug use, housing, social activities, and benefits. The assessment is followed by the pharmacist treating the patient, referring to other services, and the Simon Community worker assessing benefits, social activities and housing, before addressing all or some of these as required.
Researchers are interested in testing whether the PHOENIx intervention can reduce the chance of people who are homeless overdosing with drugs. To do this properly, they need to run a full scale randomised controlled trial (where participants are allocated to an intervention group or usual care at random), but to enable the test to work properly, they first must check, in a miniature study, whether they can recruit and retain enough people in the trial. They also need to work out whether the intervention runs as planned and whether they can collect enough data to enable a bigger test to proceed.

Who can participate?
Adults who are homeless and have recently experienced a non-fatal drug overdose.

What does the study involve?
All participants will receive a baseline assessment from a researcher. Then participants will be allocated at random to either the intervention group or usual care. People allocated to the intervention group will be offered weekly visits by the PHOENIx team (pharmacist and Simon Community worker) who will assess and help participants with their health, housing, benefits and social prescribing. All of this will be in addition to the care they would normally receive from their GP, nurses, hospitals, social care, voluntary sector, etc. The researchers will not be withdrawing any existing services from participants. Participants in the usual care group will receive the same level of care as usual from all of the services available in health, social and third sector agencies, but will not receive the additional offer of support from the PHOENIx team.

What are the possible benefits and risks of participating?
The PHOENIx team may help people improve their health (physical, mental and addictions) by starting them on treatments (directly or through the patient’s GP/Addictions team), helping them to move into safer, better accommodation, offering activities to enable more fulfilling use of time, and help maximise benefits. There are no risks of participating.

Where is the study run from?
NHS Greater Glasgow and Clyde, Pharmacy and Prescribing Support Unit (UK)

When is the study starting and how long is it expected to run for?
November 2020 to August 2022

Who is funding the study?
The Scottish Government (Drug Deaths Task Force) (UK)

Who is the main contact?
Richard Lowrie
Richard.lowrie@ggc.scot.nhs.uk

Contact information

Dr Richard Lowrie
Scientific

Clarkston Clinic, Busy Road, Glasgow
Glasgow
G76 7AT
United Kingdom

Phone	+44 (0)7971827565
Email	Richard.lowrie@ggc.scot.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx (PHOENIx) after drug overdose for people experiencing homelessness: a pilot randomised controlled trial
Study acronym	PHOENIx
Study objectives	The PHOENIx intervention reduces the risk of drug overdose in people experiencing homelessness; the pilot study examines whether the definitive trial should proceed and if so, how.
Ethics approval(s)	Approved 17/02/2021, South East Scotland Research Ethics Committee 01 (2nd Floor, Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 (0)7814 764 241; Sandra.Wyllie@nhslothian.scot.nhs.uk)
Health condition(s) or problem(s) studied	Homelessness, drug overdose
Intervention	Participants are randomized using a telephone randomization service provided by the University of Birmingham The intervention group receive weekly visits to the patient in their place of residence or other city centre low threshold venue by pharmacist/nurse independent prescriber plus simon Community Scotland outreach worker. The pair will offer an assessment of physical, mental and addiction problems followed by immediate treatment, prescription of medicines and/or referral with assertive follow up. Housing, benefits and social activities will also be assessed and referral made to a relevant agency. The usual care group will receive the same level of care as usual from all of the services available in health, social and third sector agencies, but will not receive the additional offer of support from the PHOENIx team. Total duration of intervention: between 6 and 9 months Follow-up: 8-11 months after baseline assessment.
Intervention type	Mixed
Primary outcome measure(s)	Current primary outcome measures as of 13/02/2024: Achievement of criteria for progression to RCT: 1. Recruitment rate recorded as 100 participants consenting to participate by 4 months 2. Data collection: at least 80% of participants with data collected (baseline, 6 and 9 months follow up) 3. Intervention adherence: at least 60% of participants in the PHOENIx group receiving the intervention 4. Retention: at least 60% of participants remaining in the study (receiving in-person or telephone follow-up assessment at 6 and 9 months post-randomisation) 5. Improvement in the rate of presentation to Emergency Departments and overdoses collected by researchers from health and social care records at 6 or 9 months follow up Previous primary outcome measures: Achievement of criteria for progression to RCT: recruitment rate recorded as 100 participants consenting to participate by 4 months
Key secondary outcome measure(s)	Current secondary outcome measures as of 13/02/2024: Assessed by researchers as close as possible to planned 6 and 9 months after baseline: 1. The number of participants with, and time to first, overdose or hospitalisation measured using health and social care records 2. The number of participants receiving prescribed treatment for physical or mental health and problem drug use measured using health records 3. The number of treatments per participant measured using health records 4. Health-related quality of life measured using Euro Qol-Visual Analogue Scale (EQ-VAS) which forms part of the self-rated EQ-5D-5L 5. Healthcare contacts measured using health records 6. Missed appointments measured using health records 7. Work and impact of self-management on functioning and well-being measured using the Patient Experience with Treatment and Self-management (PETS) measure 8. Number of primary health care contacts measured using clinical records 9. Number of missed and attended out-patient appointments measured using clinical records 10. Frailty measured using Fried’s adapted frailty phenotype 11. Anxiety/depression measured using Patient Health Questionnaire-4 (PHQ-4) 12. Breathlessness measured using modified Medical Research Council (MRC) breathlessness scale 13. Peak flow rate measured using a peak flow meter 14. Participant-reported injecting drug use 15. Attempted suicide measured using self-report and from clinical records 16. Self-harm measured using self-report 17. Welfare entitlements measured using self-report 18. Social prescribing measured using self-report 19. Tenancy type measured using self-report Previous secondary outcome measures: Rate of overdose measured by collecting data from NHS Greater Glasgow and Clyde clinical records from baseline until the date of follow-up (8-11 months after baseline assessment)
Completion date	01/08/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Total final enrolment	128
Key inclusion criteria	1. Adult 2. Homeless 3. Drug overdose in the past 6 months
Key exclusion criteria	Current exclusion criteria as of 13/02/2024: 1. Unable to give written informed consent 2. Living in a residential or community-based rehabilitation facility which has direct access to in-house medical and nursing care Previous exclusion criteria: Critically unwell/under the influence and unable to comprehend the request
Date of first enrolment	01/02/2021
Date of final enrolment	30/06/2021

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

NHS Greater Glasgow and Clyde

Glasgow City Centre
Glasgow
G76 7AT
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 data will not be available because the researchers have not asked patients to consent to use outside the scope described in the patient information and associated materials approved by the ethics committee (pending).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Interim results article		04/04/2023	05/04/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file		18/05/2022	12/08/2022	No	No

Additional files

39053 Protocol 18May2022.pdf: Protocol file

Editorial Notes

13/02/2024: The exclusion criteria and primary and secondary outcome measures were updated. Ethics approval details and IRAS number added. The intention to publish date was changed from 30/09/2022 to 01/04/2024.
05/04/2023: Publication reference added.
12/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
09/08/2022: The total final enrolment was added.
08/06/2021: The recruitment end date was changed from 01/06/2021 to 30/06/2021.
23/11/2020: Trial's existence confirmed by the Scottish Government (Drug Deaths Task Force) (UK).