Baseline characteristics of people experiencing homelessness with a recent drug overdose in the PHOENIx pilot randomised controlled trial.

BACKGROUND: Drug-related deaths in Scotland are the highest in Europe. Half of all deaths in people experiencing homelessness are drug related, yet we know little about the unmet health needs of people experiencing homelessness with recent non-fatal overdose, limiting a tailored practice and policy response to a public health crisis. METHODS: People experiencing homelessness with at least one non-fatal street drug overdose in the previous 6 months were recruited from 20 venues in Glasgow, Scotland, and randomised into PHOENIx plus usual care, or usual care. PHOENIx is a collaborative assertive outreach intervention by independent prescriber NHS Pharmacists and third sector homelessness workers, offering repeated integrated, holistic physical, mental and addictions health and social care support including prescribing. We describe comprehensive baseline characteristics of randomised participants. RESULTS: One hundred and twenty-eight participants had a mean age of 42 years (SD 8.4); 71% male, homelessness for a median of 24 years (IQR 12-30). One hundred and eighteen (92%) lived in large, congregate city centre temporary accommodation. A quarter (25%) were not registered with a General Practitioner. Participants had overdosed a mean of 3.2 (SD 3.2) times in the preceding 6 months, using a median of 3 (IQR 2-4) non-prescription drugs concurrently: 112 (87.5%) street valium (benzodiazepine-type new psychoactive substances); 77 (60%) heroin; and 76 (59%) cocaine. Half (50%) were injecting, 50% into their groins. 90% were receiving care from Alcohol and Drug Recovery Services (ADRS), and in addition to using street drugs, 90% received opioid substitution therapy (OST), 10% diazepam for street valium use and one participant received heroin-assisted treatment. Participants had a mean of 2.2 (SD 1.3) mental health problems and 5.4 (SD 2.5) physical health problems; 50% received treatment for physical or mental health problems. Ninety-one per cent had at least one mental health problem; 66% had no specialist mental health support. Participants were frail (70%) or pre-frail (28%), with maximal levels of psychological distress, 44% received one or no daily meal, and 58% had previously attempted suicide. CONCLUSIONS: People at high risk of drug-related death continue to overdose repeatedly despite receiving OST. High levels of frailty, multimorbidity, unsuitable accommodation and unmet mental and physical health care needs require a reorientation of services informed by evidence of effectiveness and cost-effectiveness. Trial registration UK Clinical Trials Registry identifier: ISRCTN 10585019.

Pharmacist led homeless outreach engagement and non-medical independent prescribing (Rx) (PHOENIx) intervention for people experiencing homelessness: a non- randomised feasibility study.

BACKGROUND: Homelessness and associated mortality and multimorbidity rates are increasing. Systematic reviews have demonstrated a lack of complex interventions that decrease unscheduled emergency health services utilisation or increase scheduled care. Better evidence is needed to inform policy responses. We examined the feasibility of a complex intervention (PHOENIx: Pharmacist led Homeless Outreach Engagement Nonmedical Independent prescribing (Rx)) to inform a subsequent pilot randomised controlled trial (RCT). METHODS: Non-randomised trial with Usual Care (UC) comparator group set in Greater Glasgow and Clyde Health Board, Scotland. Participants were adult inpatients experiencing homelessness in a city centre Glasgow hospital, referred to the PHOENIx team at the point of hospital discharge, from 19th March 2018 until 6th April 2019. The follow up period for each patient started on the day the patient was first seen (Intervention group) or first referred (UC), until 24th August 2019, the censor date for all patients. All patients were offered and agreed to receive serial consultations with the PHOENIx team (NHS Pharmacist prescriber working with Simon Community Scotland (third sector homeless charity worker)). Patients who could not be reached by the PHOENIx team were allocated to the UC group. The PHOENIx intervention included assessment of physical/mental health, addictions, housing, benefits and social activities followed by pharmacist prescribing with referral to other health service specialities as necessary. All participants received primary (including specialist homelessness health service based general practitioner care, mental health and addictions services) and secondary care. Main outcome measures were rates of: recruitment; retention; uptake of the intervention; and completeness of collected data, from recruitment to censor date. RESULTS: Twenty four patients were offered and agreed to participate; 12 were reached and received the intervention as planned with a median 7.5 consultations (IQR3.0-14.2) per patient. The pharmacist prescribed a median of 2 new (IQR0.3-3.8) and 2 repeat (1.3-7.0) prescriptions per patient; 10(83%) received support for benefits, housing or advocacy. Twelve patients were not subsequently contactable after leaving hospital, despite agreeing to participate, and were assigned to UC. Two patients in the UC group died of drug/alcohol overdose during follow up; no patients in the Intervention group died. All 24 patients were retained in the intervention or UC group until death or censor date and all patient records were accessible at follow up: 11(92%) visited ED in both groups, with 11(92%) hospitalisations in intervention group, 9(75%) UC. Eight (67%) intervention group patients and 3(25%) UC patients attended scheduled out patient appointments. CONCLUSIONS: Feasibility testing of the PHOENIx intervention suggests merit in a subsequent pilot RCT.

Protocol for a pilot randomised controlled trial to evaluate integrated support from pharmacist independent prescriber and third sector worker for people experiencing homelessness: the PHOENIx community pharmacy study.

BACKGROUND: People experiencing homelessness (PEH) have complex health and social care needs and most die in their early 40 s. PEH frequently use community pharmacies; however, evaluation of the delivery of structured, integrated, holistic health and social care intervention has not been previously undertaken in community pharmacies for PEH. PHOENIx (Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx) has been delivered and tested in Glasgow, Scotland, by NHS pharmacist independent prescribers and third sector homelessness support workers offering health and social care intervention in low threshold homeless drop-in venues, emergency accommodation and emergency departments, to PEH. Building on this work, this study aims to test recruitment, retention, intervention adherence and fidelity of community pharmacy-based PHOENIx intervention. METHODS: Randomised, multi-centre, open, parallel-group external pilot trial. A total of 100 PEH aged 18 years and over will be recruited from community pharmacies in Glasgow and Birmingham. PHOENIx intervention includes structured assessment in the community pharmacy of health, housing, benefits and activities, in addition to usual care, through weekly visits lasting up to six months. A primary outcome is whether to proceed to a definitive trial based on pre-specified progression criteria. Secondary outcomes include drug/alcohol treatment uptake and treatment retention; overdose rates; mortality and time to death; prison/criminal justice encounters; healthcare utilisation; housing tenure; patient-reported measures and intervention acceptability. Analysis will include descriptive statistics of recruitment and retention rates. Process evaluation will be conducted using Normalisation Process Theory. Health, social care and personal resource use data will be identified, measured and valued. DISCUSSION: If the findings of this pilot study suggest progression to a definitive trial, and if the definitive trial offers positive outcomes, it is intended that PHOENIx will be a publicly funded free-to-access service in community pharmacy for PEH. The study results will be shared with wider stakeholders and patients in addition to dissemination through medical journals and scientific conferences. TRIAL REGISTRATION: International Clinical Trial Registration ISRCTN88146807. Approved protocol version 2.0 dated July 19, 2022.

Pharmacist and Homeless Outreach Engagement and Non-medical Independent prescribing Rx (PHOENIx): a study protocol for a pilot randomised controlled trial.

INTRODUCTION: The number of people experiencing homelessness (PEH) is increasing worldwide. Systematic reviews show high levels of multimorbidity and mortality. Integrated health and social care outreach interventions may improve outcomes. No previous studies have targeted PEH with recent drug overdose despite high levels of drug-related deaths and few data describe their health/social care problems. Feasibility work suggests a collaborative health and social care intervention (Pharmacist and Homeless Outreach Engagement and Non-medical Independent prescribing Rx, PHOENIx) is potentially beneficial. We describe the methods of a pilot randomised controlled trial (RCT) with parallel process and economic evaluation of PEH with recent overdose. METHODS AND ANALYSIS: Detailed health and social care information will be collected before randomisation to care-as-usual plus visits from a pharmacist and a homeless outreach worker (PHOENIx) for 6-9 months or to care-as-usual. The outcomes are the rates of presentations to emergency department for overdose or other causes and whether to progress to a definitive RCT: recruitment of ≥100 participants within 4 months, ≥60% of patients remaining in the study at 6 and 9 months, ≥60% of patients receiving the intervention, and ≥80% of patients with data collected. The secondary outcomes include health-related quality of life, hospitalisations, treatment uptake and patient-reported measures. Semistructured interviews will explore the future implementation of PHOENIx, the reasons for overdose and protective factors. We will assess the feasibility of conducting a cost-effectiveness analysis. ETHICS AND DISSEMINATION: The study was approved by South East Scotland National Health Service Research Ethics Committee 01. Results will be made available to PEH, the study funders and other researchers. TRIAL REGISTRATION NUMBER: ISRCTN10585019.