Australian studies investigating parental factors often lack meaningful inclusion of Aboriginal and Torres Strait Islander families, limiting our understanding of current influences on positive developmental trajectories within communities. There is growing recognition of the need for culturally safe and responsive longitudinal research that is co-designed and co-led by the community for the community. An Indigenous-led birth cohort study of Aboriginal and Torres Strait Islander families in Queensland, Australia, has therefore been developed to better understand health across generations.

The Strong Families Study is a co-designed prospective longitudinal birth cohort study that will follow 400 Indigenous families in Queensland from pregnancy until the child reaches 5 years of age. Eligible participants include pregnant individuals (

This study was approved by the Mater Misericordiae Ltd Human Research Ethics Committee (HREC/MML/105191) and ratified by the University of Queensland Human Research Ethics Committee (2025/HE001924). Endorsement letters were secured from partner services at each study site. Findings will be shared with partnering hospitals and funding bodies at conferences and through reports and peer-reviewed publications.

To evaluate the value of linked electronic health records (EHRs) for measuring stroke care quality in England before and after the COVID-19 pandemic, focusing on metrics not routinely captured: stroke incidence, dispensing of secondary prevention medications and a proxy of disability—time spent at home after stroke (‘home-time’).

Prospective cohort study using national linked datasets.

England-wide health data linkage including the Sentinel Stroke National Audit Programme (SSNAP), primary and secondary care, dispensed medications and mortality records, accessed via National Health Service (NHS) England’s Secure Data Environment.

425 675 adults with a first stroke between 1 January 2020 and 31 December 2023; data were available for 304 210 in primary care, 279 825 in hospital admissions, 220 470 in SSNAP and 59 465 in death records.

Annual stroke incidence; first-year medication dispensing rates for antiplatelets, anticoagulants, antihypertensives and lipid-lowering agents (with a 1-month washout period) and home-time at 180 days post stroke.

Stroke ascertainment was highest when combining all sources, with 10.8% of non-fatal ischaemic strokes recorded exclusively in primary care and 19.4% of fatal strokes identified solely through death records. Standardised annual stroke incidence rose from 227.6 (95% CI 226.1 to 229.0) to 244.8 (95% CI 243.4 to 246.3) per 100 000 over the study period including the COVID-19 pandemic. During the COVID-19 lockdown, non-fatal stroke recordings decreased while stroke-related deaths rose, indicating that recording quality was sensitive to shifts in healthcare-seeking behaviour during the pandemic. Among people with ischaemic stroke, 89.1% received an antiplatelet or anticoagulant, 44.5% an antihypertensive and 80.5% a lipid-lowering therapy. For haemorrhagic stroke, these proportions were: for anticoagulants 13.5%, antiplatelets 13.2%, antihypertensives 46.6% and lipid lowering 41.1%. Medication dispensing for stroke prevention declined with increasing age and comorbidity, but varied little by ethnicity, region or pandemic period. Mean home-time within 180 days of stroke was 166.6 (95% CI 166.4 to 166) days, decreasing with greater age (141.4 days for 90 years or older (95% CI 140.7 to 142.1)), deprivation (166.4 days (95% CI 166.1 to 166.6) for most deprived quintile) and stroke severity (137.4 days for National Institutes of Health Stroke Scale (NIHSS) score on arrival over 22 (95% CI 135.8 to 139.1)) and increasing with years from the COVID-19 pandemic 2023 (169.3 days (95% CI 169.0 to 169.5) vs 2020 164.4 days (95% CI 164.1 to 164.7)).

Standardised stroke incidence increased significantly over the study period, highlighting a growing public health burden that persisted despite disruptions due to the pandemic although variation in case ascertainment and stroke coding practices was observed. While secondary prevention coverage for antiplatelets and lipids was high, lower rates of dispensing of antihypertensives, particularly in older and comorbid populations, potentially signal a target for improvement. Home-time represents a sensitive, person-centred outcome that exposes disparities linked to socioeconomic deprivation and clinical severity that can be used to enhance routine stroke audits. These findings justify the expansion of linked EHR infrastructure and the modernisation of governance frameworks to enable the longitudinal evaluation of care quality beyond the COVID-19 era.

Androgen deprivation therapy (ADT) improves survival in advanced prostate cancer but may lead to debilitating side effects, including sarcopenic obesity and a 10–45% increased risk of other comorbidities. Guidelines recommend exercise and nutrition interventions during ADT, but access to these services is often limited, and referral pathways are unclear. This study aims to evaluate the feasibility and preliminary efficacy of an online, home-based, multi-faceted, exercise, nutrition and education programme (ProHealth) for men with prostate cancer treated with ADT. ProHealth was co-designed with consumers and healthcare professionals to include (i) education on prostate cancer and treatment-related side effects and (ii) multimedia behaviour change resources to support individualised nutrition and exercise behaviour change.

This 12-week randomised controlled trial (target n=50) will include men treated with ADT for >3 months or who have completed ADT in the last 24 months, are overweight or obese and are not under the care of a dietitian or exercise professional. Participants will be randomised (1:1) to the ProHealth intervention or usual care. The intervention group will receive four consultations with an Accredited Practising Dietitian to promote a high protein and energy reduced diet, and five consultations with an Accredited Exercise Physiologist to follow a home-based progressive resistance training and aerobic exercise programme. The primary outcomes are feasibility (recruitment rate, retention, data completeness, reach, safety, consultation attendance and adherence, and usage of the ProHealth web platform), acceptability and satisfaction of the ProHealth intervention. Exploratory secondary outcomes will be assessed at baseline and 12 weeks and include changes in body weight and composition (total and appendicular fat-free mass, fat mass), quality of life (Functional Assessment of Cancer Therapy (FACT)—General, FACT-Prostate, FACT-Fatigue), physical function (30-second sit-to-stand), dietary intake (3-day food diary) and physical activity (7-day accelerometer). Linear regression models will estimate differences between the intervention and usual care group. Qualitative interviews on participant satisfaction will be transcribed verbatim for thematic analysis.

This study is approved by Deakin University Human Research Ethics Committee (DUHREC2024-038) and registered on Australian and New Zealand Clinical Trials Registry (ACTRN12624000874516). Findings will be disseminated through peer-reviewed journals, scientific meetings and other public forums.

ACTRN12624000874516.

To identify and prioritise research uncertainties regarding the assessment, management and rehabilitation of patients with problematic hip replacements through a national Priority Setting Partnership (PSP).

A national PSP using the James Lind Alliance (JLA) methodology.

UK.

Patients, carers and healthcare professionals (HCPs) involved in the care of patients with problematic hip replacements.

A steering group was established. The James Lind Alliance methodology was followed throughout. A nationwide survey was conducted to collect unanswered questions. These were refined, prioritised through an interim survey and ranked at a final consensus workshop.

The initial survey yielded 201 questions, refined to 32. The interim survey had 191 respondents, leading to 19 questions at the final workshop. The top 10 research priorities were agreed on.

This PSP identified key research priorities for problematic hip replacements, focusing on diagnosis, pain management, perioperative optimisation and infection. These priorities can inform researchers and funders to improve outcomes for affected patients.

Risk reduction training for UK care home staff is limited, not standardised and challenging to implement. Virtual reality (VR) is an immersive, engaging method of education delivery that is being adopted in health and social care. VR may be an effective education tool in care homes, but this research has yet to be conducted.

The VR-CARE project aims to create a new VR risk reduction training programme for care homes that combines hand hygiene and falls prevention modules, and to evaluate this through a pilot trial to inform a future randomised controlled trial (RCT).

There are two research phases with patient and public involvement and engagement (PPIE) activities embedded throughout. Care home stakeholders are collaborating to design the training and toolkit, oversee methods, review resources for accessibility, support recruitment and ensure the project meets the needs of the workforce and positively impacts resident care.

In phase 1, we will use a mixed-methods and user-centred design approach to develop the VR training and an accompanying implementation toolkit needed to deliver it. The training will be developed and tested by 15 care home staff across three rounds to identify and inform changes that maximise usability and acceptability. We will conduct up to 20 interviews with staff from VR companies and care homes to support toolkit development.

Phase 2 is a mixed-methods pilot cluster RCT, with a waitlist control and process evaluation with up to 80 unregistered staff members from six North England care homes, to develop the measures and methods to inform a future trial. The process evaluation will generate knowledge about VR as a training mechanism in care homes. This phase will focus on the practicality of using VR, broader impacts (eg, on residents), contextual considerations and how it might be scaled up.

The University of Manchester Proportionate University Research Ethics Committee has approved phase 1 (Reference: 2025-24416-44642). We will obtain further approval before commencing phase 2.

Outputs will include user-friendly and acceptable VR risk reduction training for care homes, accompanied by an implementation toolkit adaptable for other VR training in social care settings. Materials (eg, training overviews, infographics and videos) will be developed to support uptake. Findings will be presented at conferences and published in journals. Lay summaries will be co-created with our PPIE group, and additional dissemination methods will be co-developed to broaden reach.

Healthcare utilisation (HU) is key to improving the health of residents in urban informal settlements. This study aimed to explore household-level factors influencing HU among informal settlement households in Freetown, Sierra Leone.

Cross-sectional survey.

Three informal settlements (Cockle Bay, Dwarzark and Moyiba) in Freetown, Sierra Leone.

Primary data from 4871 households were collected during the Health and Wellbeing survey conducted between April and May 2023, targeting households with adults aged 18 years and older.

The primary outcomes were households HU both within and outside informal settlements. Household-level predisposing and enabling explanatory variables were derived from Andersen’s Behavioural Model of HU.

Disability in households increases HU within settlements (especially in Dwarzark, 13% and Moyiba, 10%) but is less likely outside. Households engaged in income-generating activities are more likely to seek healthcare within settlements, but 12% less likely outside in Cockle Bay and Dwarzark. Food insecurity decreases HU within Dwarzark (9%) and increases HU outside by 174% in Moyiba. Longer water fetching times and water shortages were associated with higher HU (between 6% and 16%) within settlements, especially in Cockle Bay and Dwarzark. Clean water sources (eg, piped dwelling, bowser, surface, bottled) were consistently associated with higher HU both within and outside settlements. Shared sanitation facilities (such as shared toilets) were positively associated with HU both within and outside settlements, particularly in Dwarzark and Moyiba. Households with income from fishing, informal salaried work and bike riding showed higher HU both within and outside settlements, especially in Dwarzark and Moyiba.

We identified strong settlement-specific patterns of household-level factors that influence HU both within and outside Freetown’s informal settlements. These findings provide a foundation for developing targeted policies such as strengthening local services, addressing affordability and accessibility barriers and supporting vulnerable occupation groups.

The Optimising older People’s Transition from acute care Into residential aged care through Multidisciplinary Assessment and Liaison (OPTIMAL) trial is a multisite hybrid type II stepped wedge randomised controlled trial with an embedded process evaluation that aims to evaluate the effectiveness of implementing a bundle of evidence-based interventions to provide systematic support to older adults being discharged from hospital to residential aged care (RAC) homes for the first time. The trial is based on evidence from models of care used internationally to improve the quality of care transitions and addresses a need to provide evidence of transferability and effectiveness of these models in the Australian context. The embedded process evaluation will assess the acceptability, appropriateness, feasibility, adoption and fidelity of the OPTIMAL intervention, as well as the mechanisms of impact.

The OPTIMAL trial will be implemented across the three metropolitan local health networks (LHNs) in South Australia. The process evaluation will be conducted in parallel with the main trial and is theoretically informed by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) implementation framework, which theorises that the implementation success of OPTIMAL is determined by the facilitation of the intervention with the intended recipients in their inner and outer contextual setting. The process evaluation will employ a mixed methods approach. Qualitative and quantitative data will be collected through baseline context mapping of LHNs, interviews with key LHN and RAC stakeholders, online survey of clinical teams, fortnightly check-in forms, and activity logs and field notes maintained by the nurse facilitator in each LHN. Data will be mapped and reported based on the i-PARIHS framework.

Ethical approval for the OPTIMAL trial was obtained from the Southern Adelaide Clinical Human Research Ethics Committee (approval 2023/HRE00111), and the relevant governance approvals were obtained for each participating LHN. Ethical approval includes a waiver of the requirement for consent for routinely collected patient data. Study findings will be disseminated via journal publications, presentations at conferences, stakeholder discussions, consumer forums and advocacy to key decision makers to support knowledge translation.

Australia New Zealand Clinical Trial Registry, ACTRN12624001008516, registered 20 August 2024.

This study investigates the potential of digital health technologies (DHTs), such as wearable devices and smartphones, to complement traditional submaximal functional capacity tests, such as the 6 min walk test (6MWT) and the timed up and go test (TUG). While these traditional tests are widely used due to their simplicity and relevance to daily living activities, they have limitations, including infrequent administration and the need for clinical observation. DHT offers continuous, real-world monitoring, which may accurately reflect patients’ health status and effectively inform clinical decisions. However, there is a need to establish the validity of the data and metrics computed through DHT and understand patient perspectives on using such technology.

This is an observational pilot study (Synergy Digital Health study) that aims at linking wearable data with traditional test outcomes and assessing participants’ acceptance and usage of such DHT. A cohort of 30 cardiovascular patients from Oxford University Hospitals, UK, and 30 community-dwelling elderly people from social centres in Helsingborg, Sweden, will use wearable devices for 2 months in free-living conditions, they will fill out technology acceptance questionnaires (AQs), have baseline assessments and perform physical tests such as the 6MWT and TUG using the Mobistudy smartphone app. Subgroups will participate in codesign workshops to identify experience-based design recommendations for the technology. Quantitative and qualitative methods will be adopted to analyse the collected data.

The study protocol received ethical approval in Sweden from the Etikprövningsmyndigheten (2024-04886-01) and in the UK from the National Health Service (NHS) Research Ethics Committees (Iras project ID: 340870), in accordance with local regulations. All participants are asked for written informed consent. The results of the study will be shared via scientific journals and conferences.

To determine the safety and efficacy of ruxolitinib (RUX) and fostamatinib (FOS) compared with standard of care (SOC) in patients requiring hospital admission for the treatment of COVID-19 pneumonia.

Adaptive multiarm, multistage, randomised, open-label trial (three arm, two stage).

Five hospitals in England between October 2020 and September 2022.

Hospitalised patients (≥18 years) with COVID-19 pneumonia defined by a modified WHO COVID-19 severity grade of 3 or 4.

Participants were randomly assigned 1:1:1 to receive RUX (10 mg two times per day for 7 days then 5 mg two times per day for 7 days), FOS (150 mg two times per day for 7 days then 100 mg two times per day for 7 days) or SOC.

Primary outcome was development of severe COVID-19 pneumonia (modified WHO severity grade≥5) within 14 days of randomisation. Secondary outcomes included mortality, invasive and non-invasive ventilation, venous thromboembolism, duration of hospital stay, readmissions, inflammatory markers and serious adverse events (SAEs).

At stage 1, 181 patients were randomised, with 4 assessed as ineligible post randomisation. FOS was stopped early for futility with 16 participants (27.6%, n=58) developing severe COVID-19 pneumonia compared with 15 (25.0%, n=60) in the SOC arm (adjusted odds ratio (aOR) compared with SOC: 1.12; 95% CI 0.49 to 2.58; p=0.608). RUX progressed to stage 2 but the trial was stopped early due to slow recruitment. At the final analysis, 10 participants (16.1%, n=62) developed severe COVID-19 pneumonia in the RUX arm compared with 15 (24.6%, n=61) in the SOC arm (aOR: 0.63; 95% CI 0.25 to 1.57; p=0.161). Four (7.4%) participants in the FOS arm, none in the RUX arm and three (5.5%) in the SOC arm died within 14 days of randomisation. Infections were the most frequently reported SAE and were numerically higher in the FOS (10, 17.2%) and RUX (10, 16.1%) arms compared with SOC (7, 11.5%). Two unexpected serious adverse reactions occurred in the RUX arm only.

We found no evidence that FOS was superior to SOC for the treatment of COVID-19 pneumonia in patients requiring hospital admission. Due to early stopping, the trial was underpowered to establish RUX’s effect in this population. Further study is needed.

NCT04581954; EUDRA-CT: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001750-22/GB.

Outcome from large vessel occlusion stroke can be significantly improved by time-critical thrombectomy but treatment is only available in regional comprehensive stroke centres (CSCs). Many patients are first admitted to a local primary stroke centre (PSC) and require transfer to a CSC, which delays treatment and decreases the chance of a good outcome. Access to thrombectomy might be improved if eligible patients could be identified in the prehospital setting and selectively redirected to a CSC. This study is evaluating a new specialist prehospital redirection pathway intended to facilitate access to thrombectomy.

This study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. Clusters are ambulance stations (or teams) which are work bases for ambulance practitioners. Intervention allocated ambulance practitioners use the Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (‘SPEEDY’) pathway which comprises initiation according to specific criteria followed by contact with CSC staff who undertake a remote assessment to select patients for direct CSC admission. Control allocated ambulance practitioners continue to provide standard care which comprises admission to a local PSC and transfer to a CSC for thrombectomy if required. A co-primary outcome of thrombectomy treatment rate and time from stroke symptom onset to thrombectomy treatment will evaluate the impact of the pathway. Secondary outcomes include key aspects of emergency care including prehospital/hospital time intervals, receipt of other treatments including thrombolysis, and performance characteristics of the pathway. A broad population of all ambulance practitioner suspected and confirmed stroke patients across participating regions is being enrolled with a consent waiver. Data about SPEEDY pathway delivery are captured onto a study case record form, but all other data are obtained from routine healthcare records. Powered on a ‘primary analysis population’ (ischaemic stroke patients with pathway initiation criteria), 894 participants will detect an 8.4% difference in rate and data from 564 thrombectomy procedures will detect a 30 minute difference in time to treatment. The full study population is estimated to be approximately 80 000. Regression modelling will be used to examine primary and secondary outcomes in several analysis populations. The economic analyses will include cost-effectiveness and cost–utility analyses, and calculation of willingness to pay at a range of accepted threshold values. The process evaluation involves semi-structured interviews with professionals and patient/family members to explore views and experiences about the SPEEDY pathway.

This study has ethical, Health Research Authority and participating NHS Trust approvals.

Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.

ISRCTN77453332.

Existing psychological and pharmacological interventions for young people at ultra-high risk (UHR) for psychosis have shown benefit in at least delaying the transition to psychosis, but they have limited benefit for comorbid disorders or social dysfunction, which are prominent for those at UHR. We developed a moderated online social therapy platform (named Momentum) including: (1) transdiagnostic therapeutic interventions targeting social functioning, depression, generalised anxiety and social anxiety; (2) a moderated, peer-led online community and (3) specialised human support from clinicians, career consultants and peer workers. The aim of this trial is to determine whether, in addition to treatment as usual (TAU), Momentum, a 12-month digital intervention, informed by the complex intervention framework, is superior to 12 months of TAU in improving social functioning in UHR young people.

The study design is a prospective, parallel group, rater-masked randomised controlled trial. We will recruit young people aged 14–27 years, meeting one or more UHR for psychosis criteria. Participants are randomly assigned to the condition using randomly permutated blocks with a 1:1 allocation ratio. Participants are stratified by age (

Melbourne Health Human Research Ethics Committee (HREC/42964/MH-2018) provided ethics approval for this study. Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website. De-identified individual participant data will be available after publication for 3 years via the Health Data Australia catalogue (https://www.researchdata.edu.au/health). Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. Supplementary material including study protocol, informed consent material and statistical analysis plan will also be available.

Australian New Zealand Clinical Trial Registry (ANZCTR), ACTRN12619001411134.

Drug poisoning, caused predominantly by fentanyl in the unregulated drug supply, is the leading cause of death among persons 10–59 years in British Columbia (BC), Canada. In March 2020, in response to the emergence of the COVID-19 pandemic, the province of BC released the Risk Mitigation Guidance (RMG) as a clinical tool for physicians and nurse practitioners, allowing prescribers to provide selective withdrawal management medications, such as hydromorphone, dextroamphetamine, diazepam and others, as a legal and regulated supply of pharmaceutical alternatives to individuals who were at-risk of COVID-19 and overdose. In July 2021, the government of BC released the prescribed safer supply (PSS) policy, extending the scope beyond the COVID-19 pandemic and initial medications offered under the RMG. Recent studies have shown clear benefits among people with a diagnosed opioid use disorder who were prescribed PSS, in reducing mortality, as well as improving retention on opioid agonist treatment for those who were coprescribed PSS medications. The objective of the analysis detailed in this protocol is to use a cross-model comparison approach, comparing two independently developed models which are currently used in public health institutions in BC, to estimate the impact of this policy on opioid overdose-related mortality, while also considering the potential negative impacts of PSS medication diversion to those who are opioid naïve. This project will add to the limited evidence-base on the population-level impact of pharmaceutical alternatives interventions to date.

We have identified two appropriate mathematical models to evaluate the impact of PSS on the number of opioid overdose-related deaths within BC from the inception of the programme (March 2020) until December 2022. We will use recently established guidelines on conducting a cross-model comparison to identify structural and parameter differences between the models and perform adaptation steps to generate the counterfactual scenarios. These will include creating additional health states for the population representing individuals receiving PSS, and parameterising the overdose risk, mortality and retention in the new compartments from a comprehensive population-level data set. Harmonisation will be conducted to ensure that both models evaluate the same scenarios with the same data. Further sensitivity analyses will be conducted to consider alternative counterfactual scenarios and changes to the population following the implementation of the intervention.

This study is exempt from research ethics board review, as outlined in the Tri-Council Policy Statement, because it relies on data that is available in the public domain and there is no possibility of identifying individual persons. Results of the model validation analysis will be distributed through peer-reviewed journals and knowledge translation materials posted on the websites of the BC Centre for Disease Control and Centre for Advancing Health Outcomes.

https://osf.io/kju2p/overview.

Declined donor organs and explanted recipient organs may hold considerable value for biomedical research, particularly in advancing knowledge of disease mechanisms and supporting drug development. However, public perceptions of such use, and preferences for how consent should be obtained, remain underexplored.

Four workshops were held across the UK to examine the views of organ donor families and transplant recipients regarding the use of human organs in research, with a focus on myocardial regeneration. Each workshop included three brief presentations on transplantation and cardiac regeneration, followed by facilitated small-group discussions. Observational notes were taken to capture participants’ perspectives on the use of organs unsuitable for transplantation. A follow-up survey generated both quantitative and qualitative data, the latter analysed using thematic analysis.

Participants expressed strong support for the use of declined donor and explanted recipient organs in research. Transplant recipients frequently cited a desire to give back to the National Health Service (NHS), while donor families viewed research use as a meaningful way to honour their loved ones when transplantation was not possible.

This exploratory study highlights widespread support for using non-transplantable organs in research among individuals with personal experience of transplantation. The findings suggest a need for further research into how best to support and inform potential donors and families. Participants emphasised the importance of sensitive communication, clear consent processes and transparency regarding the use of donated organs.

We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.

To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.

A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.

Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.

While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.

A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.

The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.

This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.

ISRCTN46969988.

To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.

Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.

Four prisons for men across England and Wales, UK.

Men leaving prison at risk of homelessness and intervention delivery staff.

CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.

Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.

The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.

This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.

ISRCTN46969988.