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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.
RESUMEN
OBJECTIVE: We retrospectively evaluated the effectiveness of trauma-focused psychotherapy (TF-P) versus stabilization and waiting in a civilian cohort of patients with an 11th version of the international classification of disease (ICD-11) diagnosis of complex post-traumatic stress disorder (CPTSD). METHODS: We identified patients with CPTSD treated at a specialist trauma service over a 3-year period by triangulating evidence from self-report questionnaires, file review, and expert-clinician opinion. Patients completed a phase-based treatment: stabilization consisting of symptom management and establishing safety, followed by waiting for treatment (phase 1); individual TF-P in the form of trauma-focused cognitive behavioral therapy (TF-CBT), or eye movement desensitization and reprocessing (EMDR) or TF-CBT plus EMDR (phase 2). Our primary outcome was PTSD symptoms during phase 2 versus phase 1. Secondary outcomes included depressive symptoms, functional impairment, and a proxy CPTSD measure. Exploratory analysis compared outcomes between treatments. Adverse outcomes were recorded. RESULTS: Fifty-nine patients were included. Compared to receiving only phase 1, patients completing TF-P showed statistically significant reductions in PTSD [t(58) = -3.99, p < 0.001], depressive symptoms [t(58) = -4.41, p < 0.001], functional impairment [t(58) = -2.26, p = 0.028], and proxy scores for CPTSD [t(58) = 4.69, p < 0.001]. There were no significant differences in outcomes between different treatments offered during phase 2. Baseline depressive symptoms were associated with higher PTSD symptoms and functional impairment. CONCLUSIONS: This study suggests that TF-P effectively improves symptoms of CPTSD. However, prospective research with validated measurements is necessary to evaluate current and new treatments and identify personal markers of treatment effectiveness for CPTSD.