Richard Lowrie

Introduction: People who are housebound frequently miss general practice-based long-term condition (LTC) reviews. Missingness from LTC reviews are associated with poorer health outcomes and higher costs. General practice pharmacy collaboration within primary care teams may help address the housebound missingness care gap. Aim: To evaluate the feasibility of implementing the Care-at-Home Pharmacotherapy Service, a general practice pharmacy technician-clinical pharmacist domiciliary review model for housebound patients living in areas of socioeconomic deprivation. Method: Pre-post intervention study, in two primary care general practices serving a socioeconomically deprived locality. Inclusion criteria: adults ≥ 60 years, coded as housebound with ≥ 2 LTCs and ≥ 5 regularly prescribed medications. Exclusions: adults lacking capacity or receiving palliative care. Baseline data: demographics, Scottish Index of Multiple deprivation (SIMD, a national measure of area-level deprivation), number of regular medications, falls frequency, health-related quality-of-life (EQ5D5L) score, and unscheduled care. Pharmacy technician domiciliary visits involved medication review, adherence support, education and physical assessment. A pharmacist provided clinical supervision and clinical review. Pre-post review outcomes were assessed at 3 months. Results: Twenty-five patients were included (median age 81, range 60–89; 56% female), with 56% living in the most deprived SIMD quintile. In total, twenty-three patients had missed 91 LTC reviews since becoming housebound and were prescribed a median of 14 regular medications (range 9–27). Across 83 encounters with a pharmacy technician, 21 medications were stopped, 19 initiated, and 15 adjusted. Fifteen clinical referrals were generated. Compared with the 3 months before pre-intervention, the total number of self-reported falls during the 3-month follow-up reduced from 8 (range 0–2) to zero (range 0–0). Mean EQ-5D-5L visual analogue score increased from 57 to 62%, and unscheduled care contacts reduced from a total of 56 (range 0–7) to 21 (0–4). Conclusion: Pharmacy technician-led domiciliary review with support from a clinical pharmacist is feasible and leads to identification of actionable unmet clinical and medication- needs in older adults who are housebound.

BackgroundPeople with symptomatic COPD and comorbidities often experience suboptimal prescribing and may be housebound. A tailored, home-based intervention by independent prescriber pharmacists collaborating with consultant physicians (TICC-PCP) may improve outcomes and optimise healthcare resource use. This economic evaluation alongside the TICC-PCP multicentre pilot RCT, assessed the feasibility of collecting healthcare resource use and health-related quality of life (HRQoL) data and characterised these outcomes in this patient population.MethodsThe pilot RCT recruited 110 adults with moderate to severe COPD and comorbidities across two sites in Scotland. Participants were randomised to receive TICC-PCP plus usual care or usual care alone. Healthcare resource use and HRQoL (EQ-5D-5L) data were collected at baseline and at three-month follow-ups over 21 months. Costs were estimated from the NHS perspective (2021 GBP), applying a micro-costing approach.ResultsParticipants were 59% female with a mean age of 67.4 (SD: 8.2) and a mean of 11.5 (SD 6.9) comorbidities. EQ-5D questionnaire completion rates exceeded 90% at follow-ups with baseline mean utility being 0.324 (SD 0.369) and 25.5% of participants reporting utilities less than 0 (considered “worse than death”). Mean annual direct medical cost at baseline was £7,717.86 (SD: £9,163.52), largely driven by inpatient care. The intervention cost averaged £401.25 (SD: £159.87) per participant. Compared with usual care, the intervention showed indicative HRQoL improvement along with increased healthcare costs.ConclusionFindings demonstrate feasibility of health economic data collection and characterise the high disease burden in this population. A definitive RCT is required to determine cost effectiveness.

Background: People experiencing homelessness face up to 12 times higher mortality rates than the general population. People experiencing homelessness have multiple, unmet health and care needs, including poor physical and mental health, substance use disorder and lack of stable and safe housing, yet they do not find services accessible or tailored to their needs. Aim: The aim of this study was to assess the feasibility of conducting a larger, definitive trial evaluating an integrated clinical pharmacist/homeless third-sector support (Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx) for people experiencing homelessness, in a community pharmacy setting. Design: Randomised, multicentre, open, parallel group external pilot trial with parallel economic and qualitative process evaluation. Methods: People experiencing homelessness ≥ 18 years were recruited from community pharmacies in Glasgow and Birmingham, United Kingdom. Participants were randomised 1 : 1 to receive Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx intervention in addition to usual care or usual care only. The Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx intervention is a collaboration between National Health Service pharmacist independent prescribers and third-sector homelessness charity workers offering weekly community pharmacy and/or outreach-based consultations for people experiencing homelessness to address health (e.g. health screening, treatment and prescribing), housing and social needs (e.g. welfare benefits, housing support). A range of health, social and care outcomes were evaluated at baseline, 3 and 6 months from both usual-care and intervention participants. The primary outcome was to evaluate the feasibility of a subsequent definitive randomised controlled trial according to pre-specified progression criteria classified as green (go ahead), amber (minor amendment in procedures required for definitive trial) and red (substantial changes needed). These related to recruitment; retention; intervention adherence; and collection of clinical and social outcomes data, including emergency department visits, rough sleeping and criminal justice encounters. Results: Progression criteria were met (4 green and 1 amber) as follows: (1) recruitment (target 55% conversion rate): 100 people experiencing homelessness were recruited as planned from 5 community pharmacies, 100/183, that is, 55% eligible consented to participate – green; (2) retention (target 60%): 72 (72%) participants remained in the study at 6 months – green; (3) collection of routine healthcare utilisation data (target 60%): 91 (91%) had emergency department visit and mortality data available at 6 months – green; (4) completion of questionnaire booklet (target 60%): 72 (72%) completed the booklet at 6 months – green; (5) intervention adherence (target 60%). Twenty-six (53%) participants had over half of the planned weekly contacts with the Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx team – amber. Signals of improvements were observed, as there were fewer ambulance call-outs, fewer emergency department visits and hospitalisations; fewer nights slept rough; and improved health-related quality of life in Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx participants compared to the usual-care group at 6 months’ follow-up. Qualitative interviews conducted with participants and stakeholders. Participants suggested the Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx intervention was characterised by holistic approach, comprehensiveness, consistency and care. Challenges identified included resource constraints, integration with existing services and concerns about long-term sustainability. Conclusions: Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx community pharmacy pilot randomised controlled trial successfully achieved key progression criteria. If found to be effective and cost-effective in a subsequent definitive randomised controlled trial, it offers promise as an adaptable (United Kingdom and internationally) model of integrated care provision for people experiencing homelessness. Limitations: While small sample size limits generalisability of the, it fulfils the purpose of a pilot study. Temporary absence of intervention worker in one of the study settings constrained intervention delivery. Future trials should plan for contingency measures. Future work: Future research should seek to test and evaluate care models integrating health and voluntary sector care for people experiencing homelessness in various settings, including community pharmacy, street outreach and temporary accommodations. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR133060.

Introduction People experiencing severe and multiple disadvantage (SMD: homelessness, substance use and criminal offending) have multiple intersecting unmet health and social care needs and high mortality rates, often due to street-drug overdose. Pilot randomised controlled trials (RCTs) suggest an integrated, holistic, collaborative outreach intervention (Pharmacy Homeless Outreach Engagement Non-medical Independent Prescribing Rx (PHOENIx)) involving generalist-trained pharmacists, nurses or General Practitioners accompanied by staff from third sector homeless organisations may improve outcomes, including reducing overdose. Methods Multicentre, parallel group, prospective RCT with parallel economic and process evaluation. Set in six areas of Scotland, UK, 378 adults with SMD will be recruited and randomised (stratified by setting and previous non-fatal overdoses) to PHOENIx intervention in addition to usual care (UC) or UC. Aiming to meet participants weekly for 9–15 months, PHOENIx teams assess and address health and social care needs while referring onwards as necessary, co-ordinating care with wider health and third sector teams. During a person-centred consultation, in the participants’ choice of venue, and taking account of the participant’s priorities, the NHS clinician may prescribe, de-prescribe and treat, for example, wound care, and refer to other health services as necessary. The third sector worker may help with welfare benefit applications, social prescribing or advocacy, for example, securing stable housing. Pairings of clinicians and third sector workers support the same participants. The primary outcome is time to first fatal/non-fatal street-drug overdose at nine months. Secondary endpoints include health-related quality of life, healthcare use and criminal justice encounters. A health economic evaluation will assess cost per quality adjusted life year of PHOENIx relative to standard care. A parallel qualitative process evaluation will explore the perceptions and experiences of PHOENIx, by participants, stakeholders and PHOENIx staff. Analysis The primary and other time-to-event secondary outcomes will be analysed by Cox proportional hazards regression. Ethics and dissemination IRAS number 345246, approved 23/10/2024 by North of Scotland Research Ethics Service. Results will be shared with participants, third sector homelessness organisations, health and social care partnerships, then peer-reviewed journals and conferences worldwide, from the first quarter of 2027. Trial registration number ISRCTN12234059 registered on 20/2/2025 (ISRCTN).

To achieve progression criteria for a definitive phase three randomised controlled trial (RCT). Prospective phase two multicentre parallel-group RCT. Participants recruited from secondary care respiratory clinics in two health boards in Scotland, United Kingdom. 110 adults with moderate-severe COPD and co-morbidities. Tailored Intervention for COPD and Co-morbidities by Pharmacists and Consultant Physicians (TICC-PCP): home visits (for a year) by generalist prescribing pharmacists collaborating with consultant respiratory physicians. Pharmacists assessed, prescribed, de-prescribed, and referred participants to health and social care services as appropriate, in addition to Usual Care (UC). Recruit ≥100 participants; deliver TICC-PCP to ≥70% intervention-arm participants; collect ≥90% in-person data; retain ≥80% participants until 21-months. Secondary outcomes include clinical and health service utilisation. Recruitment, data collection, retention and participant retention targets were achieved over 21 months. TICC-PCP delivery: the median number of contacts, nine per participant in one year, matched the a-priori target although fewer than expected (13 (27%)) received the planned schedule of contacts (monthly for six months then every other month for six months). Secondary outcomes included increased prescribing of bone strengthening medicines, de-prescribing of medicines associated with increasing falls risk; delayed time to emergency health care contacts, fewer exacerbations; improved health related quality of life and longer duration of hospitalisation. A definitive phase three RCT of TICC-PCP may improve outcomes for people with moderate-severe COPD and co-morbidities. Trial registration: The trial is registered with the UK Clinical Trials Registry (https://doi.org/10.1186/ISRCTN43508703). Registration date: 3/1/2020.

People experiencing homelessness (PEH) are amongst the most marginalised populations in the society. Despite facing extreme health inequalities and poorer outcomes than the general population, they are under-represented in clinical trials. Little is hence known about the physical, mental health and social characteristics of PEH as clinical trial participants. Cross-sectoral complex interventions aiming to mitigate health, wellbeing and wider inequalities faced by PEH are urgently needed. This paper reports on baseline characteristics of PEH from the PHOENIx Community Pharmacy multicentre Pilot randomised controlled trial (RCT) with recruitment from community pharmacies in Glasgow and Birmingham, UK. Participants were randomised 1:1 to receive PHOENIx (collaboration between National Health Service pharmacist independent prescribers and third sector workers) intervention in addition to usual care (UC) or UC only. Data were collected using face-to-face patient questionnaires which included validated tools (e.g. Equation 5D), direct clinical observations (e.g. blood pressure, grip strength) and healthcare utilisation records (e.g. hospital admissions). A total of 100 participants were recruited as planned from five community pharmacies. Participants (n = 99 baseline records for one were lost) were on average 42 years old, mostly white (87, 88%), and male (81, 82%). Most had recently slept rough (57, 58%), were registered with an Alcohol and Drug Recovery Service (79, 81%), and prescribed opioid substitute therapy (74, 75%). A minority reported having a recent street substance-related overdose (15, 15%). Most participants reported one or more chronic physical health condition (83, 85%). Fifteen (15%) participants rated severity of breathlessness as 4. Thirty-four (44%) participants were deemed pre-frail and 43 (56%) as frail. Participants had an average EQ-5D-5L health-related quality of life score of 42.2 (SD 24.7). Seventy-six (77%) participants reported having a mental health condition or difficulty; depression (n = 56, 56%), anxiety (n = 47, 47%), self-harm/suicide attempt (n = 21, 21%). Only half were known to housing/casework services. Moreover, half walked to appointments and a minority of those diagnosed with a blood borne virus were in receipt of treatment. Over three quarters had been imprisoned in the past. Baseline characteristics of PEH who participated in the PHOENIx Community Pharmacy pilot RCT demonstrates multiple, complex and unmet health, social and practical needs. The data emphasises the need to engage, support, refer and treat PEH through integrated and bespoke pathways to promote people’s engagement with care, prevent repeat homelessness and early deaths. International Clinical Trials Registration ISRCTN88146807. Date of registration 18/07/2022.

Symptomatic chronic obstructive pulmonary disease (COPD) is a global health problem associated with a number of co-morbidities, disproportionately affecting people who are poor. Sub-optimal management of symptomatic COPD and co-morbidities negatively impacts quality of life, ability to work and survival. Previous trials of healthcare professional-led complex interventions have targeted COPD management, but not also simultaneously targeted the treatment of co-morbidities. Recommendations for complex intervention testing include feasibility studies followed by pilot randomised controlled trials (RCTs), including economic and parallel process evaluations. Following a feasibility study, a Tailored, home-based Intervention for people with COPD and Co-morbidities by generalist prescribing Pharmacists collaborating with Consultant respiratory Physicians (TICC PCP) is undergoing pilot testing. The pilot study aims to recruit at least 70% of invited participants within 4 months; deliver TICC PCP to at least 70% of participants in the intervention arm; retain at least 80% of participants (excluding those who died or developed incapacity before the end of the study) until 21-month data collection; and collect at least 90% of in person data at each study time point. In addition, findings from the economic and process evaluations along with information obtained on the proposed quantitative efficacy outcomes inform on the sample size required for a subsequent definitive RCT will help inform on future research. We describe methods for a multicentre pilot RCT, with parallel economic and qualitative process evaluations of TICC PCP. Set in Glasgow and Edinburgh (Scotland), we plan to recruit 100 people with symptomatic COPD and conduct home-based assessments at baseline and at subsequent three monthly follow up visits over a period of 21 months. Independent researchers will collect extensive health and social care data at recruitment (baseline) before participants are randomised (stratified by site and number of respiratory hospitalisations in the past 12 months), to TICC PCP in addition to usual care (UC), or UC alone. Collected data will include objective and subjective measures of health, healthcare utilisation (including prescribing), home circumstances, health related quality of life, healthcare resource use and intervention costs. Follow up data will be collected three monthly for 21 months. The intervention, delivered by NHS Pharmacists visiting participants at home monthly for 6 months, then every 2 months for the next 6 months, involves clinical assessment and intervention at home including prescribing for COPD and co-morbidities. Pharmacists will also assess and help participants to address wider health needs, e.g. appointment attendance and home equipment. Pharmacists will collaborate mainly with consultant respiratory physicians, and General Practitioners. A holistic, 1 year long, individualised home-based intervention for people with symptomatic COPD and co-morbidities may help address unmet health needs. We will utilise the information obtained from this pilot study, including: the recruitment and retention rates; the sample size required to detect a minimal clinically important difference in the proposed efficacy outcomes of interest; the economic analyses; and process evaluation, to determine whether we should progress to a definitive RCT with parallel process and economic evaluation. The trial is registered with the UK Clinical Trials Registry (ISRCTN 43508703).

Chronic Obstructive Pulmonary Disease (COPD) is a growing global challenge. We undertook a process evaluation embedded within the Tailored Intervention at home for patients with moderate-to-severe COPD and Co-Morbidities by Pharmacists and Consultant Physicians (TICC PCP) pilot randomised controlled trial (RCT), which explored patient/stakeholder perceptions of the intervention, acceptability of trial procedures, and barriers/facilitators to intervention implementation. Semi-structured telephone interviews were conducted with intervention patients (20) and stakeholders (10); data were analysed thematically, conceptualised through Normalisation Process Theory. Patient perspectives compared based on socio-economic status (SES). Patients/stakeholders reported positive perceptions of the intervention/trial procedures. Pharmacists provided support across a range of health/social issues. Challenges related to: recruitment; workload/lone-working; managing patient complexity; and data collection. There were suggestions Pharmacists were able to undertake more actions to support patients from low SES areas. Overall, intervention and trial procedures were acceptable to patients and stakeholders. Findings support progression to full-scale RCT.