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

Abstract

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.

Scope, content and quality of clinical pharmacy practice guidelines: a systematic review

“…Future research should evaluate published guidelines in specific areas of practice regarding their scope, strengths, limitations and applicability. Pharmacists’ roles are increasing internationally with emphasis on delivery of cognitive services and independent prescribing [ 6 , 60 – 62 ]. There is an opportunity for international professional practice societies and health systems to make a positive impact on patient care globally by developing common practice guidelines focusing on core pharmacy practice activities.…”

“…The recent COVID-19 pandemic illustrated such diversity of regulations and roles with reference to pharmacist involvement in COVID-19 vaccinations, with pharmacists’ roles ranging from traditional compounding and preparation of vaccines to vaccine administration and counselling [ 5 ]. Countries such as the UK have introduced pharmacist prescribing models which allow pharmacists to prescribe prescription medicines within their areas of competence [ 6 ]. Pharmacist involvement in medicines optimisation within general practice (family physician) clinics in the UK National Health Service [ 7 ] and the Netherlands [ 8 ] are other examples of step change when discussing emerging new clinical pharmacy roles.…”