Condition category
Not Applicable
Date applied
16/11/2020
Date assigned
05/01/2021
Last edited
05/01/2021
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Lowrie

ORCID ID

Contact details

Clarkston Clinic
Busy Road
Glasgow
Glasgow
G76 7AT
United Kingdom
+44 (0)7971827565
Richard.lowrie@ggc.scot.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1

Study information

Scientific title

Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx (PHOENIx) after drug overdose for people experiencing homelessness: a pilot randomised controlled trial

Acronym

PHOENIx

Study hypothesis

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

Not provided at time of registration

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format

Condition

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

Phase

Drug names

Primary outcome measure

Achievement of criteria for progression to RCT: recruitment rate recorded as 100 participants consenting to participate by 4 months

Secondary outcome measures

Rate of overdose measured by collecting data from NHS Greater Glasgow and Clyde clinical records from baseline until date of follow up (8-11 months after baseline assessment)

Overall trial start date

01/11/2020

Overall trial end date

01/08/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult
2 .Homeless
3. Drug overdose in the past 6 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Critically unwell/under the influence and unable to comprehend the request

Recruitment start date

01/02/2021

Recruitment end date

01/06/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde
Glasgow City Centre
Glasgow
G76 7AT
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde

Sponsor details

Clarkston Clinic
Glasgow
G76 7AT
United Kingdom
+44 (0)7971827565
Richard.lowrie@ggc.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nhsggc.org.uk/

Funders

Funder type

Government

Funder name

The Scottish Government (Drug Deaths Task Force) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers plan to publish results in a way that maximises impact if the intervention shows a signal of improvement and the definitive study is worthwhile.

IPD sharing statement
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).

Intention to publish date

30/09/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2020: Trial's existence confirmed by the Scottish Government (Drug Deaths Task Force) (UK).