Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.

We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.

The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.

NCT05828823.

Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.

This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.

The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.

NCT06794320.

Over 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.

We will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.

Ethical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.

NCT06156176

TransformUs is a multicomponent school-based programme that offers teachers professional learning and resources aligned with the Australian curriculum to promote physically active teaching and learning, a supportive environment and physical activity opportunities during recess and lunch. The programme was originally developed for students in mainstream primary schools and has been proven efficacious for increasing physical activity and reducing sedentary behaviour in children without disability. The programme has been adapted for delivery with students with disabilities in primary and secondary schools (TransformUs All Abilities). This project aims to determine the implementation at scale and effectiveness of the TransformUs All Abilities programme to increase physical activity among primary and secondary school children and adolescents with disability. This protocol describes the hybrid implementation-effectiveness trial that will be used for this evaluation.

This study employs a hybrid type II implementation-effectiveness trial to evaluate the TransformUs All Abilities programme, targeting all government and independent, primary and secondary schools in Victoria, as well as special and mainstream secondary schools in Queensland and South Australia (n=2173 eligible schools). The effectiveness trial will focus on a subgroup of government/independent special schools for students with mild to moderate intellectual disability in Victoria, involving up to three intervention and three waitlist control schools (n=61 eligible schools). In both trials, outcomes will be guided by the RE-AIM framework focusing on reach, adoption and implementation (implementation trial) and effectiveness (effectiveness trial), with data collected at baseline and 6 months. The effectiveness trial will focus on students’ device-measured physical activity and sedentary behaviour—primary outcomes—and sleep, physical literacy and cognitive functions—secondary outcomes. Teacher feedback on the programme’s adaptation and their experience with programme implementation will also be collected, alongside qualitative feedback from a subsample of students regarding engagement/enjoyment and suggestions for improvements. Implementation data will be analysed descriptively and using linear mixed models to test changes over time. Effectiveness outcomes will be analysed using linear mixed models to compare intervention and waitlist control, accounting for confounding and school/classroom clustering. Interview data will be thematically analysed.

Ethical approval for this trial was obtained from the Deakin University Human Research Ethics Committee (2021-368). Clearance to conduct research in schools was also obtained from the Education Departments of Victoria (2023-004726), Queensland (550/27/2592) and South Australia (2022-0020). Informed consent is required for participation in the study. School staff can enrol in the implementation trial via the TransformUs website, while the effectiveness trial requires organisational, staff, parental/carer consent and student assent. Results will be disseminated through academic publications, scientific conference presentations and summary reports to schools, parents and partner organisations.

ACTRN12622001082796; Universal Trial Number: U1111-1281-1103; ACTRN12622001050741: U1111-1280-8828.

Despite significant global advancements, the past decade has seen stagnation in Maternal, Neonatal and Child Health (MNCH) service coverage and a concerning high under-five and maternal mortality rates, which have been worsened by COVID-19 pandemic-related disruptions, particularly in sub-Saharan Africa. This scoping review protocol will support the comprehensive mapping, evaluation and assessment of the application, impact, effectiveness and adaptability of health-resilient frameworks in maintaining these services during pandemics, while also identifying gaps in the literature and areas for further research.

Following the Joanna Briggs Institute guidelines, a literature search across databases such as PubMed, Scopus and African Journals Online for studies published from the inception of the databases to 2024 will be conducted. Covidence will facilitate the iterative screening process by two independent reviewers. Data extraction will employ the Population, Intervention, Comparison, Outcomes and Healthcare Contexts framework to categorise information. The thematic synthesis will integrate the findings to comprehensively evaluate the framework’s application, impact, effectiveness and adaptability in the context of routine immunisation and MNCH services.

This is part of a broader study approved by the evaluation committee of the Faculty of Health Sciences at the University of the Free State, and ethical clearance was granted by the university’s Human Research Ethics Committee with registration number UFS-HSD2025/0102/2705. The findings will be shared with relevant stakeholders through publications in peer-reviewed journals and presentations at meetings, conferences, seminars and professional forums.

Total diet replacements (TDRs) and weight loss medications (WLMs) have proven effective in producing substantial weight loss for individuals with obesity. Evidence is lacking on whether combining these treatments is effective and cost-effective in primary care for adults with obesity class I (body mass index (BMI) 30–34.9) or uncomplicated obesity class II or higher (BMI≥35 without obesity-related disease).

LightCARE is a 2-year 1:1 randomised, parallel-group, clinical superiority trial with blinded outcome assessment evaluating the benefits and harms of an intensive weight loss (IWL) intervention compared with usual care for adults with obesity in Denmark and the UK. The trial will include 400 participants aged 18–60 years with obesity class I or uncomplicated obesity class II or higher. The IWL programme aims to achieve and maintain a weight loss of ≥20% through a flexible and individualised combination of TDR, behavioural support, including physical activity and sleep guidance, and WLM if needed and will continue for 2 years. The control group will receive usual care offered in each country, typically consisting of brief behavioural support for weight loss. The primary outcome is body weight 2 years after randomisation. Secondary outcomes will include the proportion of participants achieving ≥20% weight loss, Short-Form-36 Mental Component Score, 4-m gait speed and Metabolic Syndrome Severity-Z score. Serious adverse events, the incidence of eating disorders and bone mineral density will be evaluated as safety outcomes. We will also examine the cost-effectiveness of the intervention, within the trial and in the longer term through modelling. We will conduct a process evaluation to inform any future implementation.

Ethical approval was granted in Denmark (December 2023, H-23051332) and the UK (August 2024, 24/SC/0210). Findings from the trial will be disseminated through peer-reviewed journals and scientific conferences.

NCT06321432.

To explore the longitudinal experience of taking part in a physiotherapy-led exercise adherence programme as part of the OsteoPorosis Tailored exercise adherence INtervention (OPTIN) trial.

Longitudinal qualitative study using semi-structured interviews analysed with reflexive thematic analysis—an interpretive approach.

UK National Health Service.

12 participants with vertebral fragility fracture (VFF) within the exercise adherence intervention arm of the OPTIN trial (n=63 in each arm). Interviews were undertaken with each participant at three time points: (1) within the first 2 weeks of initial assessment, (2) at the end of the 16-week intervention and (3) a year post-baseline.

We distilled five themes. (1) One size does not fit all: this focuses on the importance of a physiotherapist individualising the exercise programme and how participants adapt it into their lives. (2) My mind and body can be in conflict or work together: this spotlights the strong link between one’s emotional and mental state with their physical state, and how they can work to positively or negatively affect exercise adherence behaviour. (3) Expanding my circle of support: this revolves around the need for support systems beyond family and friends to the physiotherapist and other people with osteoporosis. (4) Transitioning from an exercise programme to a lifestyle change: this encompasses a longitudinal perspective of the exercise programme tapering, becoming intermittent or dropping off after a year, then being replaced by sustained lifestyle changes. (5) Moving from fear to empowerment: this explores the fear and loss of former identity after VFF diagnosis transforming into hope, confidence and empowerment through knowledge, advice and coping strategies.

Findings highlight the need to work with mind and body to empower lifestyle changes and the importance of educating, tailoring, empathising and allying with the participant—all critical areas clinicians can target when treating patients with VFFs.

ISRCTN14465704.

Rare diseases in babies, children and young people (children) are often life-shortening, and children can require constant caregiving. Bösch et al1 report that 82% of children in tertiary hospitals in the USA have a rare disease. This study was designed to establish...

This study aims to assess how implementing a checklist for managing extremely preterm or extremely low birth weight infants can reduce mortality rates and morbidities.

A quasi-experimental, before-and-after study.

Neonatal intensive care unit at Dr. Cipto Mangunkusumo National General Hospital, a national referral hospital in Indonesia.

86 infants were born at

Implementation of a modified Canberra Health Services extremely preterm-early management checklist during the initial management of extremely preterm or low birth weight infants, including humidified gas resuscitation, thermal management, early surfactant administration and standardised first-hour care protocols.

The primary outcome was the mortality rate. Secondary outcomes included comorbidities such as hypothermia, hypoglycaemia, acidosis, intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL) and retinopathy of prematurity (ROP).

A total of 86 extremely premature and/or extremely low birth weight infants were enrolled, 48 neonates prior to and 38 neonates after the use of the checklist. Baseline characteristics were comparable between groups (median gestational age 27 weeks in both groups, median birth weight 795 g vs 868.5 g, p=0.09). Mortality at discharge showed a non-significant reduction from 52.1% to 47.4% (p=0.664, 0.91, 95% CI 0.64 to 1.30). Significant reductions were observed in IVH (79.2% to 28.9%, p

Implementation of a systematic checklist was associated with significant reductions in IVH and ROP, though mortality reduction was not statistically significant. These findings suggest potential benefits of structured early care protocols, but the observational design limits causal inference.

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

A cross-sectional mixed methods online survey.

Primary care in England.

120 clinical pharmacists with experience in conducting SMRs in primary care.

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

Young-onset type 2 diabetes (YOD), diagnosed before 40 years of age, entails a high disease burden and potential for early dependence on disability benefits. The risk of type 2 diabetes (T2D) varies with socio-economic status and ethnic background, yet the relationship between these factors and age at diagnosis is insufficiently explored. We aimed to study associations between YOD and living on disability benefits, educational level and country background.

Cross-sectional data on 8640 individuals with T2D, linked to data on educational level and country background, were compared with population data from the same residential areas. Similar comparisons were made for data on disability benefits among 3854 individuals of working age (

The risk of being dependent on disability benefits was three times higher in YOD (adjusted incidence rate ratio, aIRR (95% CI) 3.1 (2.7 to 3.5)) and twice as high in later-onset T2D (1.9 (1.8 to 2.1)) as in the general population. People of Norwegian background with low educational levels had threefold higher YOD risk (3.3 (2.4 to 4.4)) than those with a tertiary degree, while people of non-Western backgrounds with low educational levels had a smaller increase in YOD risk (1.5 (1.1 to 2.1)). People of non-Western backgrounds had higher YOD risk than those of Norwegian background (4.2 (3.5 to 5.0)), while people of south Asian background had an even greater relative YOD risk (9.0 (7.3 to 11.0)), threefold higher than for later-onset T2D (3.2 (2.8 to 3.7)).

Lifetime risk of being dependent on disability benefits was substantially higher for individuals with YOD than in later onset T2D. Non-Western and particularly south Asian backgrounds were associated with increased YOD risk. Low education was an important YOD risk factor only for people with Norwegian background.

Despite an increasing use of screens among preschool children and evidence suggesting potential adverse effects, there is a paucity of longitudinal research that aims to disentangle the multifaceted components of screen use and their unique associations with development. We present a protocol for a large-scale national longitudinal study with repeated measurements in Danish preschool children, with the aim of investigating the cross-sectional and cross-lagged longitudinal associations between screen use and psychological outcomes.

The Digital Child Study is a national prospective observational cohort of Danish preschool children. Baseline parent-report data collection commenced in 2024 via online questionnaires, and in total will include three time points over 1 year: baseline (age 4 years), and follow-ups at 6 and 12 months (ages 4.5 and 5 years). Participants were divided into two waves based on birth dates, starting in March and September 2024. Recruitment targeted parents and primary caregivers of all Danish children born between specific dates in 2020. Of 30 235 children whose parents were sent invitations, baseline questionnaire data were available for 11 690 (39%).

Children’s screen use was measured by detailed information of amount, content and timing of children’s screen use, and the broader context, incorporating parental mediation strategies, attitudes, motivations and practices. Cognitive and socioemotional developmental outcomes were measured using validated tools such as the Strengths and Difficulties Questionnaire, the Nordic Five-to-Fifteen parent questionnaire and the Behaviour Rating Inventory of Executive Function—Preschool Version. Questionnaire data will be linked to national social and health registries to enable long-term follow-up. Statistical analyses will include longitudinal modelling to explore associations between screen use and developmental outcomes, with sensitivity analyses for robustness. The study’s large sample size provides high statistical power to detect meaningful effects.

The study adheres to ethical research guidelines, ensuring voluntary participation, confidentiality and compliance with data protection laws, with approvals from relevant authorities. Findings will be disseminated through peer-reviewed publications, conferences and plain-language summaries to engage stakeholders and the broader community.

Prescribing patterns for hyperopia in children vary widely among eye care providers worldwide. This scoping review aims to identify and map the current literature on optical correction and catalogue outcomes reported, particularly in the domains of vision, vision-related functional outcomes and quality of life (QoL) in school-aged children with hyperopia.

This protocol was developed in accordance with the Joanna Briggs Institute’s Manual for Evidence Synthesis. We will include studies involving school-aged children with hyperopia without restrictions on sex, gender, race, ethnicity, type of optical correction, length of intervention, publication date or country of origin. We will include studies with internal or external comparison groups. We will exclude studies associated with myopia control treatments, ocular and visual pathway pathologies affecting vision or visual function. We will search Cochrane CENTRAL, Embase.com and PubMed. Examples of data to be extracted include population demographics, visual acuity, study-specific definitions for refractive error, treatment regimens for optical correction, vision and vision-related functional outcomes and QoL (general or vision-related) as quantified by validated instruments.

Informed consent and Institutional Review Board approval will not be required, as this scoping review will only use published data. The results from the scoping review will be disseminated by publication in a peer-reviewed scientific journal and at professional conferences.

Primary care electronic health records provide a rich source of information for inequalities research. However, the reliability and validity of the research derived from these records depend on the completeness and resolution of the codelists (ie, collections of medical terms/codes) used to identify populations of interest. The aim of this project was to develop comprehensive codelists for identifying people from ethnic minority groups, people with learning disabilities (LDs), people with severe mental illness (SMI) and people who are transgender.

We followed a three-stage process to define and extract relevant codelists. First, groups of interest were defined a priori. Next, relevant clinical codes, relating to the groups, were identified by searching Clinical Practice Research Datalink (CPRD) publications, codelist repositories and the CPRD Code Browser. Relevant codelists were extracted and merged according to group, and duplicates were removed. Finally, the remaining codes were reviewed by two general practitioners (GPs).

The curated codelists were compared using a representative sample in the UK. The frequencies of individuals identified using the curated codelists were assessed and compared with widely used alternative codelists.

Comprehensiveness was assessed in a representative CPRD population of 10 966 759 people.

After removal of duplicates and GP review, codelists were finalised with 325 unique codes for ethnicity, 558 for LD, 499 for SMI and 38 for transgender. Compared with comparator codelists, an additional 48 017 (76.6%), 52 953 (68.9%) and 508 (36.9%) people with LD, SMI or transgender code were identified. The proportions identified for ethnicity, meanwhile, were consistent with expectations for the UK (eg, 6.50% Asian, 2.66% black and 1.44% mixed).

The curated codelists are more sensitive than those widely used in practice and research. Discrepancies between national estimates and primary care records suggest potential record/retention issues. Resolving these requires further investigation and could lead to improved data quality for research.

Despite growing evidence to characterise cancer-associated cognitive decline (CACD) in women with breast cancer, interventions to mitigate CACD are limited. Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied outcome of exercise, and few high-quality studies have been conducted. In addition to knowledge gaps in effectiveness, the translation of exercise interventions to community settings remains challenging. The Breast cancer Reasoning and Activity INtervention (BRAIN) investigates the effectiveness of aerobic exercise training, delivered in a community-based setting, for improving cognitive function in women with breast cancer and gathers information on the implementation success of the intervention.

This Hybrid Type I effectiveness–implementation study is conducted at an academic medical centre in the southwestern United States in partnership with a non-profit, community health and wellness organisation. The study enrols 160 women diagnosed with stage I–IIIa breast cancer and within 3–36 months of treatment completion into a 1:1 randomised controlled trial. Individuals randomised to the exercise group receive a 6-month, individually tailored aerobic exercise programme delivered by exercise trainers employed at local community fitness centres. The programme is progressive in nature and designed to help participants achieve aerobic exercise levels consistent with guidelines for cancer survivors. Individuals randomise to the control group receive a 6-month health education control intervention delivered virtually by hospital-based health educators. Cognitive performance (primary), self-reported cognition, patient-reported outcomes, physical activity and cardiorespiratory fitness are measured at baseline, 6 months (postintervention) and 12 months (follow-up). Brain structure and function are measured via magnetic resonance imaging (MRI) at baseline and 6 months. Implementation outcomes are defined by the RE-AIM framework, which includes reach, effectiveness, adoption, implementation and maintenance. RE-AIM outcomes are measured at baseline, 6 months, 12 months and ongoing during the study.

This study was approved by the Mayo Clinic Institutional Review Board (#23-000020). All participants provide informed consent prior to participation. Findings will be disseminated to scientific, clinical and community audiences through manuscripts, presentations and newsletters.

NCT04816006.

Liver cirrhosis accounts for over 10 000 deaths in the UK each year with a total loss of 60 000 quality-adjusted life-years. There is a substantial cost to the NHS of £4.5 billion, with new liver-related decompensation events accounting for the majority of this. Following an acute cirrhosis decompensating event, there is a significant risk of hospital readmission with 90-day readmission rates as high as 53%. Current care in the UK is reactive and patients are often only readmitted when they have presented acutely as an emergency with significant decompensation.

CirrhoCare is a prospective, multicentre, randomised controlled trial comparing the CirrhoCare management system with standard-of-care for high-risk cirrhosis patients who have been discharged following an admission with acute decompensation. The CirrhoCare management system comprises a novel digital platform for use in a patient’s home, designed to proactively detect the first signs of new decompensation in patients with established cirrhosis, discharged to the community. This enables a clinician to instigate early community-based care or, if needed, to triage the patient for hospital interventions.

214 patients will be recruited to the CirrhoCare trial from at least 12 UK centres. Patients will be randomised on a 1:1 ratio allocation to the CirrhoCare Management System or standard of care. Participants who are randomised to CirrhoCare will receive a CirrhoCare health kit comprising a smart watch, smart phone with enabled SIM (Subscriber Identity Module) network card, blood pressure monitor, weighing scales and thermometer. Participants will take measurements every morning Monday to Friday and will be followed up for 90 days postdischarge.

The primary objective of this study is to assess the clinical effectiveness of the CirrhoCare digital management system. We hypothesise that its early community-based intervention will reduce the number of unplanned hospital interventions and admissions and prevent liver-related complications when compared with standard-of-care management.

CirrhoCare is a National Institute for Health and Care Research-funded study (NCT06223893). The study has UK Research Ethics Committee and Health Research Authority (HRA) approvals, with approval granted by the HRA and Health and Care Research Wales committee. The results of this study will be published in peer review journals, disseminated at international conferences as well as established Patient and Public Involvement and Engagement networks.

ISRCTN11380842.