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

Introduction Numbers 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. Methods Detailed 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. Discussion The 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 dissemination The 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 details The trial is registered with the UK Clinical Trials Registry ([ISRCTN 10585019][1]). Strengths and limitations of the study ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN 10585019 ### Clinical Protocols ### Funding Statement The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: NHS Scotland Research Ethics Committee I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All relevant data for the study will be made available on study completion [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN10585019