Improving the health of people experiencing homelessness with recent drug overdose: rationale for and design of the Pharmacist and Homeless Outreach worker Engagement Non-medical Independent prescribing Rx (PHOENIx) pilot randomised controlled trial

IntroductionNumbers of People Experiencing Homelessness (PEH) are increasing worldwide. Systematic reviews show high levels of multimorbidity and mortality due to treatable diseases including drug overdose. Integrated health and social care outreach interventions may improve outcomes. No previous studies have targeted PEH with recent drug overdose despite their high recorded levels of drug related deaths. There are few data on health and social care problems. Feasibility work suggests a collaborative health and social care intervention (Pharmacist and Homeless Outreach Engagement Non-medical Independent prescriber Rx-PHOENIx) is potentially beneficial. We describe the methods of a pilot randomised controlled trial(RCT) with parallel process and economic evaluation in PEH with at least one drug-related overdose in the preceding 6 months. MethodsDetailed health and social care information will be collected at baseline before 1:1 randomisation to: care-as-usual plus visits from a pharmacist and homeless outreach worker (PHOENIx) for 6-9 months; or care-as-usual. The main outcomes are rate of presentations to emergency department(ED) for overdose or other causes and whether to progress to a definitive RCT based on: recruitment of [≥] 100 participants within 4 months;[≥] 60% patients remaining in the study at 6 and 9 months follow up;[≥] 60% of patients in the PHOENIx group receiving the intervention; and[≥] 80% of patients with data collected. Secondary outcomes include: hospitalisations; treatment uptake and patient reported measures. Semi-structured interviews will explore future implementation of PHOENIx, and reasons for overdose and protective factors. An economic evaluation will assess the feasibility of conducting a cost effectiveness analysis in a subsequent definitive trial. DiscussionThe study will determine whether to proceed to a definitive RCT for PEH aiming to fulfil unmet health and social care needs of those experiencing homelessness and at risk of drug related harms and deaths while providing useful insights into barriers and facilitators to PHOENIx and characterising the health and social care needs of PEH. Ethics and disseminationThe trial was approved by the South East Scotland National Health Service Research Ethics Committee 01. Results will be available in the last quarter of 2022. Registration detailsThe trial is registered with the UK Clinical Trials Registry (ISRCTN 10585019). Strengths and limitations of the study- We plan to recruit patients normally excluded from intervention trials and collect a diverse health and social care dataset at baseline - The 6-9 month individualised, complex intervention offers longer consultations, integrated continuous, health and social care support on outreach - Mixed methods will enable determination of whether a subsequent trial is merited from an efficacy, economic and patient perspective. - By design, the pilot randomised controlled trial lacks the power to detect a clinically significant effect and recruitment was limited to 20 locations in Scotlands largest city