Title: Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx (PHOENIx) community pharmacy based pilot randomised controlled trial
Funder: Department of Health and Social Care

Abstract: People experiencing homelessness are among the most marginalised, destitute and vulnerable group of people in the UK. Despite most homeless persons being in their late 30s, most have 7 different health problems. This is on a par with people aged 85 years 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. _x000D_ _x000D_ Most health services operate by appointment, in buildings, whereas homeless persons are displaced and live on the streets, 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, untreated and they drop out of care unintentionally, because of their chaotic circumstances. Drug overdose, repeat cycle of homelessness, 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. _x000D_ _x000D_ Community pharmacies are often used by homeless persons on a daily basis 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. _x000D_ 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 are trusted by people who are homeless. They operate separately and do not formally share information with the health service leading to missed opportunities._x000D_ _x000D_ In this study, we are testing a new model of care that has been developed in Galsgow to offer integrated health and social care support for people experiencing homelessness. A pharmacist prescriber will work in partnership with a third sector homelessness support 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, social prescribing. It helps people get onto treatments for their physical, mental health and addictions. Now we would like to see whether it generates a signal of improvement by testing the approach in a controlled way, and see if there is signal that 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, to influence policy decisions, roll out the intervention across the UK, and improve the health of people who are homeless, which is long overdue. _x000D_ _x000D_ We aim to share our findings with homeless persons and staff, in medical journals, 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.

Lay abstract: Background_x000D_ People experiencing homelessness (PEH) have complex health and social care needs. They have 7 different health problems on average and most die in their early 40s. PEH readily access community pharmacies but community pharmacies are not formally integrated into care pathways involving case finding, assessment, treatment, or referral. PHOENIx is a new model of care originating in Glasgow involving a pharmacist independent prescriber and third sector homelessness support worker outreaching to PEH. Feasibility work shows promising quantitative and qualitative outcomes._x000D_ _x000D_ Research Question_x000D_ Does a pilot randomised controlled trial (RCT) of community pharmacy based PHOENIx merit progression to a definitive trial? _x000D_ _x000D_ Aim_x000D_ To test recruitment, retention, intervention adherence and fidelity. _x000D_ _x000D_ Methods_x000D_ Randomised, multi-centre, open, parallel group external pilot trial with parallel economic and qualitative process evaluation. _x000D_ _x000D_ Setting_x000D_ Community pharmacies in Glasgow and Birmingham. Target population: PEH aged 18 years and over. _x000D_ _x000D_ Intervention_x000D_ Pharmacist independent prescriber with a third sector homelessness support charity worker conduct structured health, housing, benefits and activities assessment in the community pharmacy then intervene at the patient’s pace, to address multiple health and social care priorities, by treating, prescribing, and onward referral in conjunction with the rest of the multidisciplinary health and social care team. Systematic weekly follow up for 6 months, according to patient’s needs. _x000D_ _x000D_ Usual care_x000D_ Signposting to a GP or other health/social care. _x000D_ _x000D_ Outcomes_x000D_ Primary- whether to proceed to a definitive trial based on pre-specified progression criteria._x000D_ _x000D_ Secondary_x000D_ Measures of drug/alcohol treatment uptake and treatment retention; overdose rates; mortality and time to death; numbers of missed appointments; number of people and days in prison/criminal justice encounters; number, time to and cause of Emergency Department/hospitalisations; GP practice visits; medication changes; housing tenure including night shelter visits, time in rehabilitation; level of debt; patient reported measures and intervention acceptability. _x000D_ _x000D_ Sample size_x000D_ 100 participants from 4 pharmacies. From 200 eligible persons, we will measure recruitment rate with 95% CI width of ~ 20%. _x000D_ _x000D_ Data analysis_x000D_ Recruitment and retention rates, exploratory analyses according to the intention to treat principle through descriptive statistics of the outcome measures. _x000D_ _x000D_ Process evaluation_x000D_ Normalisation Process Theory to conceptualise qualitative data from study participants, staff and stakeholders. _x000D_ _x000D_ Health economics_x000D_ Health, social care and personal resource use data will be identified, measured and valued. The acceptability and frequency of EQ-5D-5L to generate QALYs will give an indicative picture of cost-effectiveness. _x000D_ _x000D_ Timelines_x000D_ 22 months _x000D_ _x000D_ Anticipated impact and dissemination_x000D_ If the pilot shows sufficient signal that progression to a definitive trial is merited, and if the definitive trial delivers favourable outcomes, PHOENIx will be a walk-in, free to access service in community pharmacy for PEH in addition to usual care, within locally agreed pathways. We plan to share pilot study results with patients, stakeholders and our PPI leads; and in medical journals and scientific conferences.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: MENTAL HEALTH