Personalised recommendations for hospitalised patients with Acute Kidney Injury using a Kidney Action Team (KAT-AKI): protocol and early data of a randomised controlled trial.

INTRODUCTION: Although studies have examined the utility of clinical decision support tools in improving acute kidney injury (AKI) outcomes, no study has evaluated the effect of real-time, personalised AKI recommendations. This study aims to assess the impact of individualised AKI-specific recommendations delivered by trained clinicians and pharmacists immediately after AKI detection in hospitalised patients. METHODS AND ANALYSIS: KAT-AKI is a multicentre randomised investigator-blinded trial being conducted across eight hospitals at two major US hospital systems planning to enrol 4000 patients over 3 years (between 1 November 2021 and 1 November 2024). A real-time electronic AKI alert system informs a dedicated team composed of a physician and pharmacist who independently review the chart in real time, screen for eligibility and provide combined recommendations across the following domains: diagnostics, volume, potassium, acid-base and medications. Recommendations are delivered to the primary team in the alert arm or logged for future analysis in the usual care arm. The planned primary outcome is a composite of AKI progression, dialysis and mortality within 14 days from randomisation. A key secondary outcome is the percentage of recommendations implemented by the primary team within 24 hours from randomisation. The study has enrolled 500 individuals over 8.5 months. Two-thirds were on a medical floor at the time of the alert and 17.8% were in an intensive care unit. Virtually all participants were recommended for at least one diagnostic intervention. More than half (51.6%) had recommendations to discontinue or dose-adjust a medication. The median time from AKI alert to randomisation was 28 (IQR 15.8-51.5) min. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of each study site (Yale University and Johns Hopkins institutional review board (IRB) and a central IRB (BRANY, Biomedical Research Alliance of New York). We are committed to open dissemination of the data through clinicaltrials.gov and sharing of data on an open repository as well as publication in a peer-reviewed journal on completion. TRIAL REGISTRATION NUMBER: NCT04040296.

[Implementation of the HEARTS Initiative in Argentina: initial resultsImplementação da Iniciativa HEARTS na Argentina: primeiros resultados]. / Implementación de la Iniciativa HEARTS en Argentina: primeros resultados.

Cardiovascular diseases are the leading cause of mortality and morbidity in the Region of the Americas, and hypertension is one of the main risk factors. In 2018, Argentina began implementing the HEARTS Initiative in five primary health care centers, through the National Plan for the Prevention and Control of Arterial Hypertension. This study presents the impact its implementation has had on the indicators of effective coverage, treatment, combination therapy, and control. The HEARTS Initiative has multiple components; these include training health teams, reassigning tasks based on the transfer of clinical competencies, providing automatic and clinically validated blood pressure measurement devices, and using a single standardized treatment protocol. A longitudinal data model (generalized estimating equation analysis) was used, and the information from the five health centers was grouped using weighted averages according to the size of the population under coverage. Analysis of the results was stratified into two time periods delimited by the imposition of restrictions due to COVID-19. During the first period of 18 months, significant improvement was observed in treatment (5.9%; p<0.01) and combination therapy (13.4%; p<0.01), with no significant change in coverage (8.4%; p=0.87) and with a paradoxical decrease in control (-3.3%; p=0.02). When the period of restrictions was compared to the previous period, a generalized reduction was observed in all indicators, particularly coverage (-23.6%; p<0.01) and control (-12.5%; p<0.01). However, treatment and combination therapy levels remained above baseline values (1.7%; p<0.01 and 5.4%; p<0.01, respectively).

As doenças cardiovasculares são a principal causa de morbimortalidade, e a hipertensão, seu principal fator de risco. Em 2018, a Argentina começou a implementar a Iniciativa HEARTS em 5 centros de atenção primária à saúde por meio do Plano Nacional de Prevenção e Controle da Hipertensão Arterial. Este estudo apresenta o impacto de sua implementação nos indicadores de cobertura efetiva, tratamento, tratamento combinado e controle. A Iniciativa HEARTS inclui vários componentes. Entre eles, se destacam a capacitação das equipes de saúde, a reorganização das tarefas com base na transferência de competências clínicas, a disponibilização de aparelhos automáticos e clinicamente validados para aferição da pressão arterial e a utilização de um único protocolo padronizado de tratamento. Foi utilizado um modelo de equações de estimativas generalizadas para a análise de dados longitudinais, e as informações dos 5 centros de saúde foram agrupadas por meio de médias ponderadas de acordo com o tamanho da população coberta. A análise dos resultados foi estratificada em dois períodos de tempo delimitados pela irrupção das restrições em virtude da COVID-19. Durante os primeiros 18 meses, houve melhora significativa no tratamento (5,9%; p<0,01) e no tratamento combinado (13,4%; p<0,01), sem mudança significativa na cobertura (8,4%; p=0,87) e com uma diminuição paradoxal no controle (−3,3%; p=0,02). Durante as restrições e em relação ao período anterior, verificou-se redução generalizada em todos os indicadores, principalmente na cobertura (−23,6%; p<0,01) e no controle (−12,5%; p<0,01). No entanto, os níveis de tratamento e tratamento combinado persistiram acima dos valores basais (1,7%; p<0,01 e 5,4%; p<0,01, respectivamente).

Implementación de la Iniciativa HEARTS en Argentina: primeros resultados Implementation of the HEARTS Initiative in Argentina: initial results Implementação da Iniciativa HEARTS na Argentina: primeiros resultados

RESUMEN Las enfermedades cardiovasculares son la principal causa de morbimortalidad, y la hipertensión es su principal factor de riesgo. En 2018, Argentina comenzó a implementar la Iniciativa HEARTS en 5 centros de atención primaria de salud a través del Plan Nacional de Prevención y Control de la Hipertensión Arterial. En este estudio se presenta el impacto de su implementación en los indicadores de cobertura efectiva, tratamiento, tratamiento combinado y control. La Iniciativa HEARTS incluye múltiples componentes;entre ellos se destacan la capacitación de los equipos de salud, la reorganización de las tareas basada en la transferencia de competencias clínicas, la provisión de dispositivos de medición de la presión arterial automáticos y clínicamente validados, y la utilización de un único protocolo de tratamiento estandarizado. Se utilizó un modelo de datos longitudinales del tipo ecuación de estimación generalizada, y se agrupó la información de los 5 centros de salud mediante promedios ponderados según el tamaño de la población bajo cobertura. El análisis de los resultados fue estratificado en dos períodos de tiempo delimitados por la irrupción de las restricciones debidas al COVID-19. Durante el primer período de 18 meses se observó una mejoría significativa en el tratamiento (5,9%;p<0,01) y el tratamiento combinado (13,4%;p<0,01), sin cambios significativos en la cobertura (8,4%;p=0,87) y con un descenso paradojal en el control (−3,3%;p=0,02). Durante las restricciones y respecto del período previo, se constató una reducción generalizada en todos los indicadores, principalmente en la cobertura (−23,6%;p<0,01) y el control (−12,5%;p<0,01). Sin embargo, los niveles de tratamiento y tratamiento combinado persistieron por encima de los valores basales (1,7%;p<0,01 y 5,4%;p<0,01, respectivamente).