PHOENIx community pharmacy trial

  • Research type

    Research Study

  • Full title

    Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx (PHOENIx) community pharmacy based pilot randomised controlled trial

  • IRAS ID

    309760

  • Contact name

    Vibhu Paudyal

  • Contact email

    v.paudyal@bham.ac.uk

  • Sponsor organisation

    The University of Birmingham

  • ISRCTN Number

    ISRCTN88146807

  • Duration of Study in the UK

    1 years, 10 months, 1 days

  • Research summary

    A randomised, multicentre, open, parallel group external pilot trial with parallel economic and qualitative process evaluation. The pilot will assess the feasibility of conducting a larger, definitive trial assessing an integrated clinical pharmacist / homeless third sector intervention (PHOENIx) delivered in a community pharmacy setting. The pilot RCT will test recruitment, retention, acceptability, trial procedures and potential future implementability and scalability of the intervention. 100 people (≥18 years) experiencing homelessness will be recruited. 15-20 of these participants will be included in a qualitative substudy, plus 7-10 health care professionals and 7-10 stakeholders. Participating pharmacies will be located in parts of Glasgow and Birmingham city centre and immediate surrounding areas

    For the intervention group, in addition to usual care, the PHOENIx team (pharmacist independent prescriber in partnership with a third sector charity worker) will assess the participants’ physical, mental and addictions health, housing, benefits and social activities. The PHOENIx team will record the participant’s priorities, will assess, treat, prescribe, and refer to other health and social care teams. Participants allocated to usual care will not receive consultations from the PHOENIx team.
    The primary outcome is the feasibility of a subsequent phase III trial RCT according to pre-specified progression criteria (appeal and acceptance to participants and data collection).

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    22/EM/0119

  • Date of REC Opinion

    29 Jul 2022

  • REC opinion

    Further Information Favourable Opinion