PHOENIx

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

 

Design

PHOENIx is a randomised, multicentre, open, parallel group external pilot trial with parallel economic and qualitative process evaluation.

The RCT is a randomised controlled parallel arm trial where participants will be randomised in a 1:1 ratio to the PHOENIx intervention or control group.

Aim of the Study

The primary aim of PHOENIx trial is to assess the feasibility and acceptability of PHOENIx intervention in homelessness people. 

Setting

Suitable patients will be identifed at 2 community pharmacies within Glasgow and 2 within Birmingham city centre where Persons experiencing homelessness (PEH) are known to frequent. Backup sites (other community pharmacies) will be asked to participate in the event that recruitment is slow in each of the four main community pharmacies, during the first 2 weeks. 

Target Population

Adult patients experiencing homelessness and who are attending  or service users of one of the designated community pharmacies. 

Intervention

Participants will be randomised to either the PHOENIx Intervention or control group (standard care).

If randomised to the intervention group, a pharmacist and third sector worker will assess the patient's physical mental health as well as other needs and then work with the patient to address them. 

If randomised to the control group, a pharmacist will assess  the patient's needs and then signpost them to the relevant support agencies such as their GP or alcohol and drug support services. 

Measurement of outcomes

 The primary outcome is the feasibility of a subsequent phase III randomised controlled trial (RCT) according to pre-specified progression criteria. We are primarily interested in whether:

  • the trial is appealing to participants (assessed by the recruitment rate)
  • the PHOENIx intervention is acceptable (measured by adherence)
  • we are able to collect routine data required to evaluate the effectiveness of the intervention

We will also evaluate:

  • the recruitment and randomisation processes

The data collected will be used to review the sample size assumptions for the definitive trial to be conducted in the future. 

Process outcome measures

Data will be collected on outcome measures that would be collected in a definitive RCT to ensure that there are no issues with the completion of these measures in preparation for the main trial. We will objectively assess the following:

  • Recruitment
  • Retention
  • Intervention adherence
  • Routine data collection
  • Proportion of patient reported outcomes collected
  • Proportion of economic data collected

Data in relation to clinical, social and patient reported outcomes will also be collected. These will include:

  • health services utilisation
  • social care outcomes (such as housing and level of debt)
  • patient reported measures (including intervention acceptability and quality of life)