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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...

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Autores principales: Paudyal, Vibhu, Lowrie, Richard, Mair, Frances S., Middleton, Lee, Cheed, Versha, Hislop, Jennifer, Williamson, Andrea, Barnes, Nigel, Jolly, Catherine, Saunders, Karen, Allen, Natalie, Jagpal, Parbir, Provan, George, Ross, Steven, Hunter, Carole, Tearne, Sarah, McPherson, Andrew, Heath, Helena, Lombard, Cian, Araf, Adnan, Dixon, Emily, Hatch, Amy, Moir, Jane, Akhtar, Shabana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9946705/
https://www.ncbi.nlm.nih.gov/pubmed/36814302
http://dx.doi.org/10.1186/s40814-023-01261-x
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author Paudyal, Vibhu
Lowrie, Richard
Mair, Frances S.
Middleton, Lee
Cheed, Versha
Hislop, Jennifer
Williamson, Andrea
Barnes, Nigel
Jolly, Catherine
Saunders, Karen
Allen, Natalie
Jagpal, Parbir
Provan, George
Ross, Steven
Hunter, Carole
Tearne, Sarah
McPherson, Andrew
Heath, Helena
Lombard, Cian
Araf, Adnan
Dixon, Emily
Hatch, Amy
Moir, Jane
Akhtar, Shabana
author_facet Paudyal, Vibhu
Lowrie, Richard
Mair, Frances S.
Middleton, Lee
Cheed, Versha
Hislop, Jennifer
Williamson, Andrea
Barnes, Nigel
Jolly, Catherine
Saunders, Karen
Allen, Natalie
Jagpal, Parbir
Provan, George
Ross, Steven
Hunter, Carole
Tearne, Sarah
McPherson, Andrew
Heath, Helena
Lombard, Cian
Araf, Adnan
Dixon, Emily
Hatch, Amy
Moir, Jane
Akhtar, Shabana
author_sort Paudyal, Vibhu
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-023-01261-x.
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spelling pubmed-99467052023-02-23 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 Paudyal, Vibhu Lowrie, Richard Mair, Frances S. Middleton, Lee Cheed, Versha Hislop, Jennifer Williamson, Andrea Barnes, Nigel Jolly, Catherine Saunders, Karen Allen, Natalie Jagpal, Parbir Provan, George Ross, Steven Hunter, Carole Tearne, Sarah McPherson, Andrew Heath, Helena Lombard, Cian Araf, Adnan Dixon, Emily Hatch, Amy Moir, Jane Akhtar, Shabana Pilot Feasibility Stud Study Protocol 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-023-01261-x. BioMed Central 2023-02-23 /pmc/articles/PMC9946705/ /pubmed/36814302 http://dx.doi.org/10.1186/s40814-023-01261-x Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Paudyal, Vibhu
Lowrie, Richard
Mair, Frances S.
Middleton, Lee
Cheed, Versha
Hislop, Jennifer
Williamson, Andrea
Barnes, Nigel
Jolly, Catherine
Saunders, Karen
Allen, Natalie
Jagpal, Parbir
Provan, George
Ross, Steven
Hunter, Carole
Tearne, Sarah
McPherson, Andrew
Heath, Helena
Lombard, Cian
Araf, Adnan
Dixon, Emily
Hatch, Amy
Moir, Jane
Akhtar, Shabana
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9946705/
https://www.ncbi.nlm.nih.gov/pubmed/36814302
http://dx.doi.org/10.1186/s40814-023-01261-x
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