ABSTRACT
Background: Heart failure (HF) is a debilitating condition associated with enormous public health burden. Management of HF is complex as it requires care-coordination with different cadres of health care providers. We propose to develop a team based collaborative care model (CCM), facilitated by trained nurses, for management of HF with the support of mHealth and evaluate its acceptability and effectiveness in Indian setting. Methods: The proposed study will use mixed-methods research. Formative qualitative research will identify barriers and facilitators for implementing CCM for the management of HF. Subsequently, a cluster randomised controlled trial (RCT) involving 22 centres (tertiary-care hospitals) and more than 1500 HF patients will be conducted to assess the efficacy of the CCM in improving the overall survival as well as days alive and out of hospital (DAOH) at two-years (CTRI/2021/11/037797). The DAOH will be calculated by subtracting days in hospital and days from death until end of study follow-up from the total follow-up time. Poisson regression with a robust variance estimate and an offset term to account for clustering will be employed in the analyses of DAOH. A rate ratio and its 95% confidence interval (CI) will be estimated. The scalability of the proposed intervention model will be assessed through economic analyses (cost-effectiveness) and the acceptability of the intervention at both the provider and patient level will be understood through both qualitative and quantitative process evaluation methods. Potential Impact: The TIME-HF trial will provide evidence on whether a CCM with mHealth support is effective in improving the clinical outcomes of HF with reduced ejection fraction in India. The findings may change the practice of management of HF in low and middle-income countries.
ABSTRACT
BACKGROUND: Sex-based differences have been found in outcomes following ST-segment myocardial infarction (STEMI). Studies assessing sex-based differences in STEMI among Indian patients have reported conflicting results. METHODS: A prospective multicenter registry of consecutive patients with STEMI who presented to percutaneous coronary intervention (PCI)-capable hospitals in the Indian state of Kerala between June 2013 and March 2017 was used to assess 1-year outcomes. The primary endpoint was a composite of major adverse cardiac events (MACE), including death, stroke, nonfatal myocardial infarction, and rehospitalization for heart failure. Outcomes of 2 sex-based propensity score-matched groups were compared. RESULTS: We included 3194 patients (19.4% women). Women presenting with STEMI were older, had more traditional cardiovascular risk factors, and were more likely to be classified as living in poverty. After propensity-score matching, women experienced greater incidence of MACE (20.9% vs 14.3%, P < 0.01), primarily driven by increased 1-year mortality (14.3% vs 8.6%, P < 0.01). Women were more likely to experience prehospital delays, compared with men. Although reperfusion rates were similar between the groups, men were more likely than women to undergo reperfusion within the first 12 hours of chest pain onset. Among patients undergoing primary PCI, women were more likely to have delayed PCI than were men (80.2% vs 72.9%, P = 0.03). Procedural characteristics were similar between groups. CONCLUSIONS: Women in this cohort experienced higher incidence of MACE at 1 year, compared to men, primarily owing to increased mortality. Timeliness of reperfusion appears to be the primary factor impacting differences in outcomes between the 2 groups and may represent an attractive target for quality-improvement initiatives.
CONTEXTE: Des différences entre les sexes ont été constatées dans les résultats obtenus à la suite d'un infarctus du myocarde avec élévation du segment ST (STEMI). Des études évaluant les différences entre les sexes parmi des patients indiens ayant subi un STEMI ont produit des résultats contradictoires. MÉTHODOLOGIE: Un registre multicentrique et prospectif de patients consécutifs qui ont subi un STEMI et se sont présentés dans des hôpitaux où pouvait être pratiquée une intervention coronarienne percutanée (ICP) dans l'État indien du Kerala entre juin 2013 et mars 2017 a été utilisé pour évaluer les résultats à 1 an. Le paramètre d'évaluation principal regroupait des événements cardiaques indésirables majeurs (ECIM) comprenant le décès, l'accident vasculaire cérébral, l'infarctus du myocarde non fatal et la réhospitalisation pour cause d'insuffisance cardiaque. Les résultats de deux groupes appariés selon les scores de propension en fonction du sexe ont été comparés. RÉSULTATS: Nous avons inclus 3 194 patients (19,4 % de femmes). Les femmes qui avaient subi un STEMI étaient plus âgées, présentaient des facteurs de risque cardiovasculaire plus classiques et étaient plus susceptibles d'appartenir à la catégorie des personnes vivant dans la pauvreté. Après l'appariement selon les scores de propension, l'incidence des ECIM était plus élevée chez les femmes (20,9 % vs 14,3 %, p < 0,01), surtout en raison d'une mortalité accrue à 1 an (14,3 % vs 8,6 %, p < 0,01). Les femmes étaient plus susceptibles de subir des retards avant l'hospitalisation que les hommes. Bien que les taux de reperfusion étaient semblables dans les groupes étudiés, les hommes étaient plus susceptibles que les femmes de subir une reperfusion dans les 12 premières heures suivant l'apparition de la douleur thoracique. Parmi les patients ayant subi une ICP primaire, les femmes étaient plus susceptibles d'être touchées par un retard d'intervention que les hommes (80,2 % vs 72,9 %, p = 0,03). Les caractéristiques de l'intervention étaient similaires dans les groupes étudiés. CONCLUSIONS: L'incidence des ECIM à 1 an au sein de cette cohorte était plus élevée chez les femmes que chez les hommes, surtout en raison d'une mortalité accrue. La rapidité de la reperfusion semble être le principal facteur ayant des répercussions sur les différences de résultats entre les deux groupes et pourrait représenter une cible intéressante dans le cadre d'initiatives d'amélioration de la qualité.
ABSTRACT
BACKGROUND: ST-elevation myocardial infarction (STEMI) continues to be a major cause of cardiovascular mortality in Kerala, India. Timely primary percutaneous coronary intervention (PCI) is the recommended reperfusion strategy for STEMI. There is limited data on the safety, effectiveness, equity and efficiency of regional primary PCI services in India. METHODS/DESIGN: The primary angioplasty registry of Kerala is a clinician-initiated prospective state-wide longitudinal hospital-based registry of patients undergoing primary PCI for STEMI. The registry aims to document the efficacy and safety of the real world use of primary PCI in Indian patients presenting with STEMI, in order to achieve regional adoption of global standard performance indicators. In addition, the registry would analyze procedural variations in the performance of primary PCI and assess its impact on relevant patient centered outcomes. We plan to enroll 6000 STEMI patients, undergoing primary PCI, across 48 hospitals. These patients would be followed up for a minimum of 1year. CONCLUSIONS: The primary angioplasty registry of Kerala would help analyze the quality and outcomes of primary PCI services in Kerala, thereby yielding insights that can help limit unacceptable procedural variations in the performance of primary PCI. Identifying deviations from guideline based therapies can form the basis of quality improvement programs, which in turn will enable hospitals to achieve better patient outcomes.
