Clinical service organisation for adults with atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is an increasingly prevalent heart rhythm condition in adults. It is considered a common cardiovascular condition with complex clinical management. The increasing prevalence and complexity in management underpin the need to adapt and innovate in the delivery of care for people living with AF. There is a need to systematically examine the optimal way in which clinical services are organised to deliver evidence-based care for people with AF. Recommended approaches include collaborative, organised multidisciplinary, and virtual (or eHealth/mHealth) models of care. OBJECTIVES: To assess the effects of clinical service organisation for AF versus usual care for people with all types of AF. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and CINAHL to October 2022. We also searched ClinicalTrials.gov and the WHO ICTRP to April 2023. We applied no restrictions on date, publication status, or language. SELECTION CRITERIA: We included randomised controlled trials (RCTs), published as full texts and as abstract only, involving adults (≥ 18 years) with a diagnosis of any type of AF. We included RCTs comparing organised clinical service, disease-specific management interventions (including e-health models of care) for people with AF that were multicomponent and multidisciplinary in nature to usual care. DATA COLLECTION AND ANALYSIS: Three review authors independently selected studies, assessed risk of bias, and extracted data from the included studies. We calculated risk ratio (RR) for dichotomous data and mean difference (MD) or standardised mean difference (SMD) for continuous data with 95% confidence intervals (CIs) using random-effects analyses. We then calculated the number needed to treat for an additional beneficial outcome (NNTB) using the RR. We performed sensitivity analyses by only including studies with a low risk of selection and attrition bias. We assessed heterogeneity using the I² statistic and the certainty of the evidence according to GRADE. The primary outcomes were all-cause mortality and all-cause hospitalisation. The secondary outcomes were cardiovascular mortality, cardiovascular hospitalisation, AF-related emergency department visits, thromboembolic complications, minor cerebrovascular bleeding events, major cerebrovascular bleeding events, all bleeding events, AF-related quality of life, AF symptom burden, cost of intervention, and length of hospital stay. MAIN RESULTS: We included 8 studies (8205 participants) of collaborative, multidisciplinary care, or virtual care for people with AF. The average age of participants ranged from 60 to 73 years. The studies were conducted in China, the Netherlands, and Australia. The included studies involved either a nurse-led multidisciplinary approach (n = 4) or management using mHealth (n = 2) compared to usual care. Only six out of the eight included studies could be included in the meta-analysis (for all-cause mortality and all-cause hospitalisation, cardiovascular mortality, cardiovascular hospitalisation, thromboembolic complications, and major bleeding), as quality of life was not assessed using a validated outcome measure specific for AF. We assessed the overall risk of bias as high, as all studies had at least one domain at unclear or high risk of bias rating for performance bias (blinding) in particular. Organised AF clinical services probably result in a large reduction in all-cause mortality (RR 0.64, 95% CI 0.46 to 0.89; 5 studies, 4664 participants; moderate certainty evidence; 6-year NNTB 37) compared to usual care. However, organised AF clinical services probably make little to no difference to all-cause hospitalisation (RR 0.94, 95% CI 0.88 to 1.02; 2 studies, 1340 participants; moderate certainty evidence; 2-year NNTB 101) and may not reduce cardiovascular mortality (RR 0.64, 95% CI 0.35 to 1.19; 5 studies, 4564 participants; low certainty evidence; 6-year NNTB 86) compared to usual care. Organised AF clinical services reduce cardiovascular hospitalisation (RR 0.83, 95% CI 0.71 to 0.96; 3 studies, 3641 participants; high certainty evidence; 6-year NNTB 28) compared to usual care. Organised AF clinical services may have little to no effect on thromboembolic complications such as stroke (RR 1.14, 95% CI 0.74 to 1.77; 5 studies, 4653 participants; low certainty evidence; 6-year NNTB 588) and major cerebrovascular bleeding events (RR 1.25, 95% CI 0.79 to 1.97; 3 studies, 2964 participants; low certainty evidence; 6-year NNTB 556). None of the studies reported minor cerebrovascular events. AUTHORS' CONCLUSIONS: Moderate certainty evidence shows that organisation of clinical services for AF likely results in a large reduction in all-cause mortality, but probably makes little to no difference to all-cause hospitalisation compared to usual care. Organised AF clinical services may not reduce cardiovascular mortality, but do reduce cardiovascular hospitalisation compared to usual care. However, organised AF clinical services may make little to no difference to thromboembolic complications and major cerebrovascular events. None of the studies reported minor cerebrovascular events. Due to the limited number of studies, more research is required to compare different models of care organisation, including utilisation of mHealth. Appropriately powered trials are needed to confirm these findings and robustly examine the effect on inconclusive outcomes. The findings of this review underscore the importance of the co-ordination of care underpinned by collaborative multidisciplinary approaches and augmented by virtual care.

INFORM-AF II-Phase 1 pilot randomised controlled trial evaluating the effect of an atrial fibrillation digital education programme: study protocol.

AIM: To evaluate the effect of a novel, co-designed, digital AF educational program, 'INFORM-AF', to reduce re-hospitalisation of people with AF. The secondary aims are to examine the effect of the intervention on: (a) reducing cardiovascular-related hospitalisation, (b) increasing medication adherence, AF-related knowledge, and Atrial fibrillation (AF)-related quality of life and (c) determining the cost-effectiveness of the intervention. BACKGROUND: AF is an increasingly prevalent cardiac arrythmia that involves complex clinical management. Comprehensive education is essential for successful self-management of AF and is associated with positive health-related outcomes. There has been an increase in technology-based education for AF. However, its effects on hospitalisation, medication adherence and patient-reported outcomes are unclear. DESIGN: A prospective, randomised (1:1), open-label, blinded-endpoint, multicentre clinical trial. METHODS: Eligible participants are aged 18 years or above, diagnosed with AF, and own a smartphone. The study will be conducted at two metropolitan hospitals. In the intervention group, participants will receive the AF educational program delivered via Qstream®. In the control group, participants will receive the Stroke Foundation 'Living with AF' booklet. The primary outcome is re-hospitalisation within 12 months from an indexed presentation or hospital admission. CONCLUSION: This clinical trial is part of a developing program of work that will examine mHealth educational-behavioural interventions on cardiovascular outcomes. Findings from this pilot study will inform the development of a digital educational framework for patients living with AF. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: There remain many gaps in providing high-quality patient education for patients with AF. This trial will test a new theory-driven, smartphone-based education program on important clinical outcomes, including rehospitalisation. IMPACT: This study evaluates a novel, co-designed, digital AF educational program, 'INFORM-AF', to reduce the re-hospitalisation of people with AF. Study results are expected to be reported in 2025. Findings are expected to inform practice recommendations for AF patient education that may be included in future clinical practice guideline recommendations. REPORTING METHOD: SPIRIT Checklist. PATIENT OR PUBLICATION CONTRIBUTION: JL is a consumer co-researcher on the project and provided critical input into intervention design, and feedback and input across the study duration.

The protocol for an observational Australian cohort study of CADASIL: The AusCADASIL study.

Introduction: Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) is a rare genetic condition with a broad phenotypic presentation. This study aims to establish the first Australian cohort of individuals affected by CADASIL (AusCADASIL) and examine its clinical features and longitudinal course, and to investigate neuroimaging and blood biomarkers to assist in early diagnosis and identify disease progression. Methods: Participants will be recruited from six study centres across Australia for an observational study of CADASIL. We aim to recruit 150 participants with diagnosed CADASIL, family history of CADASIL or suspected CADASIL symptoms, and 150 cognitively normal NOTCH3 negative individuals as controls. Participants will complete: 1) online questionnaires on medical and family history, mental health, and wellbeing; 2) neuropsychological evaluation; 3) neurological examination and brain MRI; 4) ocular examination and 5) blood sample donation. Participants will have annual follow-up for 4 years to assess their progression and will be asked to invite a study partner to corroborate their self-reported cognitive and functional abilities.Primary outcomes include cognitive function and neuroimaging abnormalities. Secondary outcomes include investigation of genetics and blood and ocular biomarkers. Data from the cohort will contribute to an international consortium, and cohort participants will be invited to access future treatment/health intervention trials. Discussion: AusCADASIL will be the first study of an Australian cohort of individuals with CADASIL. The study will identify common pathogenic variants in this cohort, and characterise the pattern of clinical presentation and longitudinal progression, including imaging features, blood and ocular biomarkers and cognitive profile.