A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial.

BACKGROUND: Oral anticoagulation is underused in patients with atrial fibrillation. We assessed the impact of a multifaceted educational intervention, versus usual care, on oral anticoagulant use in patients with atrial fibrillation. METHODS: This study was a two-arm, prospective, international, cluster-randomised, controlled trial. Patients were included who had atrial fibrillation and an indication for oral anticoagulation. Clusters were randomised (1:1) to receive a quality improvement educational intervention (intervention group) or usual care (control group). Randomisation was carried out centrally, using the eClinicalOS electronic data capture system. The intervention involved education of providers and patients, with regular monitoring and feedback. The primary outcome was the change in the proportion of patients treated with oral anticoagulants from baseline assessment to evaluation at 1 year. The trial is registered at ClinicalTrials.gov, number NCT02082548. FINDINGS: 2281 patients from five countries (Argentina, n=343; Brazil, n=360; China, n=586; India, n=493; and Romania, n=499) were enrolled from 48 clusters between June 11, 2014, and Nov 13, 2016. Follow-up was at a median of 12·0 months (IQR 11·8-12·2). Oral anticoagulant use increased in the intervention group from 68% (804 of 1184 patients) at baseline to 80% (943 of 1184 patients) at 1 year (difference 12%), whereas in the control group it increased from 64% (703 of 1092 patients) at baseline to 67% (732 of 1092 patients) at 1 year (difference 3%). Absolute difference in the change between groups was 9·1% (95% CI 3·8-14·4); odds ratio of change in the use of oral anticoagulation between groups was 3·28 (95% CI 1·67-6·44; adjusted p value=0·0002). Kaplan-Meier estimates showed a reduction in the secondary outcome of stroke in the intervention versus control groups (HR 0·48, 95% CI 0·23-0·99; log-rank p value=0·0434). INTERPRETATION: A multifaceted and multilevel educational intervention, aimed to improve use of oral anticoagulation in patients with atrial fibrillation and at risk for stroke, resulted in a significant increase in the proportion of patients treated with oral anticoagulants. Such an intervention has the potential to improve stroke prevention around the world for patients with atrial fibrillation. FUNDING: Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer.

Regional differences in presentation and antithrombotic treatment of patients with atrial fibrillation: Baseline characteristics from a clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with atrial fibrillation (IMPACT-AF).

Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. However, there are few contemporary comparative data on AF from middle-income countries. METHODS: Baseline characteristics of the IMPACT-AF trial were analyzed to assess regional differences in presentation and antithrombotic treatment of AF from 5 middle-income countries (Argentina, Brazil, China, India, and Romania) and factors associated with antithrombotic treatment prescription. RESULTS: IMPACT-AF enrolled 2281 patients (69 ± 11 years, 47% women) at 48 sites. Overall, 66% of patients were on anticoagulation at baseline, ranging from 38% in China to 91% in Brazil. The top 3 reasons for not prescribing an anticoagulant were patient preference/refusal (26%); concomitant antiplatelet therapy (15%); and risks outweighing the benefits, as assessed by the physician (13%). In a multivariable model, the most significant factors associated with prescription of oral anticoagulants were no prior major bleeding (odds ratio [OR] = 4.34; 95% CI = 2.22-8.33), no alcohol abuse (OR = 2.27; 95% CI = 1.12-4.55), and history of rheumatic valvular heart disease (OR = 2.10; 95% CI = 1.36-3.26), with a strong predictive accuracy (c statistic = 0.85), whereas the most significant factors associated with prescription of a combination of oral anticoagulants and antiplatelet drugs were prior coronary revascularization (OR = 5.10; 95% CI = 2.88-9.05), prior myocardial infarction (OR = 2.24; 95% CI = 1.38-3.63), and no alcohol abuse (OR = 2.22; 95% CI = 1.11-4.55), with a good predictive accuracy (c statistic = 0.76). CONCLUSIONS: IMPACT-AF provides contemporary data from 5 middle-income countries regarding antithrombotic treatment of AF. Lack of prior major bleeding and coronary revascularization were the most important factors associated with prescription of oral anticoagulants and their combination with antiplatelet drugs, respectively.

A clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AF): design and rationale.

Atrial fibrillation (AF) is common, increasing as the population ages, and a major cause of embolic stroke. While oral anticoagulation (OAC) is highly effective at preventing stroke in patients with AF, it continues to be underused in eligible patients worldwide. The objective of this prospective, cluster randomized controlled trial (IMPACT-AF; ClinicalTrials.gov #NCT02082548) is to determine whether a comprehensive customized intervention will increase the rate and persistence of use of OAC in patients with AF. IMPACT-AF will be conducted in approximately 50 centers in 5 low- to middle-income countries. Before randomization, sites within countries will be paired to match in size, practice type and baseline rate of OAC use. Site pairs will be randomized to intervention versus control. In total, 40 to 70 patients with AF and at least 2 CHA2DS2-VASc risk factors will be enrolled at each site using a consecutive enrollment strategy, with the goal of capturing actual practice patterns. We aim for patients with a new diagnosis of AF to comprise at least 30% of the study cohort. Assuming an average baseline OAC use of 60% and a post-intervention use of 70% with a post-control rate of 60%, there will be roughly 94-98% power with 25 clusters per group (intracluster correlation coefficient of 0.02). While this trial focuses on improving treatment use and reducing preventable strokes, we also aim to better understand the reasons for OAC underuse. This will improve the intervention with the goal of creating educational recommendations to improve care for patients with AF.

High sensitivity C-reactive protein (hsCRP) & cardiovascular disease: An Indian perspective.

The role of low grade systemic inflammation as evidenced by elevated high sensitivity C-reactive protein (hsCRP) levels in the pathogenesis of atherosclerotic vascular disease has been intensely investigated through observational studies and clinical trials in the past two decades. On the basis of evidence that has accrued, hsCRP measurement has been integrated into the Reynolds risk scoring system to predict cardiovascular risk. The JUPITER trial proved the benefit of statins in cardiovascular risk reduction in patients with low grades of systemic inflammation and 'normal' cholesterol levels. However, substantial evidence has been generated from western studies. We, therefore, conducted a scoping review for studies done in India with a view to identify gaps in evidence and make further recommendations. Most Indian studies had small sample sizes and short term follow ups. There were no large population based prospective studies where patients were followed up for long periods of time for major cardiovascular end points. An analysis of the hsCRP level from the control arms of case-control studies derived a mean hsCRP value of 1.88 mg/l, which is higher than the western population where values < 1 mg/l are classified as low cardiovascular risk. Further large prospective cohort studies with longer term follow ups are essential before we can make further recommendations to integrate hsCRP into risk prediction models for cardiovascular disease prevention.

Rationale and design of a randomized controlled trial evaluating community health worker-based interventions for the secondary prevention of acute coronary syndromes in India (SPREAD).

BACKGROUND: There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease. There are no studies from low- to middle income countries (LMICs) evaluating trained community health worker (CHW)-based interventions for the secondary prevention of coronary heart disease. METHODS: We designed a hospital-based, open randomized trial of CHW-based interventions versus standard care. Patients after an acute coronary syndrome (ACS) were randomized to an intervention group (a CHW-based intervention package, comprising education tools to enhance self-care and adherence, and regular follow-up by the CHW) or to standard care for 12 months during which study outcomes were recorded. The CHWs were trained over a period of 6 months. The primary outcome measure was medication adherence. The secondary outcomes were differences in adherence to lifestyle modification, physiological parameters (blood pressure [BP], body weight, body mass index [BMI], heart rate, lipids), and major adverse cardiovascular events. RESULTS: We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities. The mean age was 56.4 (± 11.32) years, and 17.2% were females. A high prevalence of risk factors such as hypertension (43.4%), diabetes (31.9%), tobacco consumption (35.4%), and inadequate physical activity (70.5%) was documented. A little over half had ST-elevation myocardial infarction (53.7%), and 46.3% had non-ST-elevation myocardial infarction or unstable angina. CONCLUSION: The CHW interventions and training for SPREAD have been developed and adapted for local use. The results and experience of this study will be important to counter the burden of cardiovascular diseases in low- to middle income countries.

Patterns, predictors and preventability of adverse drug reactions in the coronary care unit of a tertiary care hospital.

AIM: To determine the frequency of occurrence, risk factors, clinical spectrum and drugs associated with adverse drug reactions (ADRs) occurring in the coronary care unit (CCU) of a tertiary care hospital. METHODS: This was a retrospective cohort study based on evaluation of the medical records of consecutive patients admitted to the CCU between January 2008 and December 2008. Each prescription was monitored for ADRs, and each ADR was assessed for causality, severity, predictability and preventability by two physicians using relevant scales. The chi-square test and independent t test were used to compare the ADR and non-ADR groups. Multiple binary logistic regression was used to identify risk factors for developing ADRs in the CCU. RESULTS: Of 595 patients, 152 (25.5%) developed ADRs, of which 45% were potentially preventable. Severe ADRs constituted 28.6% of the total ADRs. Patients who developed an ADR had a longer duration of stay in the hospital (2.8 extra days) (p < 0.05). Hypokalemia/hyperkalemia (22%), bleeding (11%) and cardiac arrhythmias (11%) were the commonest ADRs. The highest rates of ADRs were seen with streptokinase (59.4%). The predictors for developing an ADR in the CCU included renal dysfunction [odds ratio (OR) 1.66, 95% confidence interval (CI) 1.007-2.72], arrhythmias (OR 1.74, 95% CI 1.052-2.87) and polypharmacy with more than ten drugs (OR 11.3, 95% CI 1.45-87.44). CONCLUSION: A high frequency of ADR occurrence was identified, with many of the ADRs being potentially preventable. Patients with renal dysfunction or cardiac arrhythmias and those receiving polypharmacy were at an increased risk for developing an ADR in the CCU.

Usability and feasibility assessment of a smartphone application (Suhriday) for heart failure self-care remote monitoring in an Indian tertiary health care setting: a pilot mixed-methods study.

BACKGROUND/OBJECTIVES: Remote monitoring as a component of chronic heart failure (CHF) management programmes has demonstrated utility in reducing the risk of rehospitalisation and mortality. There is little evidence on mobile health app facilitated remote monitoring in India. We conducted a pilot usability and feasibility assessment of a smartphone-based application (Suhriday) to remotely monitor patients with CHF. METHODS: We used a mixed-methods design. Usability testing consisted of the think-aloud approach followed by semistructured in-depth interviews (SSIs) and a satisfaction questionnaire. Feasibility testing was done using acceptability and user satisfaction questionnaires in addition to SSIs. We trained five purposively sampled patients with CHF (based on health literacy and gender) and their caregivers (n=10) in self-care monitoring and app use. Usability was assessed using metrics such as task completion, time required for task completion and user satisfaction using Brooke's System Usability Scale (SUS). Content analysis of the transcripts with deductive coding was performed for both usability and feasibility interviews. The number and types of medical alerts transmitted through the app were captured and escalated to the treating team. RESULTS: Critical tasks involving (1) opening the app and identifying task list, (2) reporting blood pressure, weight, heart rate and fluid intake and (3) reporting symptoms were completed within 60 s by four patients. Median (IQR) SUS score was 85 (75-92.5) indicating high level of usability. There were 62 alerts from four patients over 4 weeks, with 36 (58.1%) excess fluid intake alerts and 16 (25.8%) blood pressure variations being the most frequent. One participant had challenges using the app and was monitored through active phone calls. CONCLUSION: Overall usability and satisfaction with Suhriday were good and we were able to remotely manage patients. However, patients with limited health literacy and those facing technological challenges required active structured telephone support.

A qualitative, grounded theory exploration of the determinants of self-care behavior among Indian patients with a lived experience of chronic heart failure.

BACKGROUND: Prior reports have documented extremely poor adherence to evidence-based medications among South Asian patients with established chronic cardiovascular diseases. Treatment adherence is now considered a part of the 'self-care' process, the determinants of which have not been adequately explored or explained among South Asian patients with chronic heart failure (CHF). Our objective was to qualitatively ascertain the determinants of the self-care process among Indian patients with a lived experience of heart failure. METHODS: We conducted in-depth interviews (audio-recorded) among 22 purposively sampled patients living with chronic heart failure, diagnosed at least 4 weeks prior to the interview and 17 caregivers (n = 39) in a tertiary care teaching hospital in Southern India. We employed an inductive analytical approach using Charmaz's constructivist grounded theory. Initial line-by-line coding and categorization was followed by memo writing, reflexive analysis after interviewing and analyzing four, eight and twelve patients, and at each stage further theoretical sampling was carried out until we reached thematic saturation. We used NVivo ver. 12 to analyze and organize data. RESULTS: The mean age of our patients was 61 years and they represented 5 Indian states and spoke seven languages, distributed across socio-economic strata and literacy levels. We classified self-care determinants into 3 broad, simple categories and defined underlying themes namely, negative determinants (passivity, entrenched beliefs, negative affect, lack of knowledge, financial difficulties, and fatalism), intermediate factors (patient expectations, provider/hospital hopping) and facilitators or positive self-care determinants (intrinsic and extrinsic facilitators). Gender and the cultural background of patients' upbringing appear to shape these determinants, thereby affecting self-care decision making in chronic heart failure. CONCLUSION: We have empirically described a unique set of self-care determinants among Indian chronic heart failure patients, which in turn are shaped by economic and socio-cultural factors. Assessing for and addressing these determinants during clinical interactions through multi-factorial approaches may help improve self-care among Indian CHF patients, thus improving treatment adherence and clinical outcomes.

Patterns and determinants of cardiovascular drug utilization in coronary care unit patients of a tertiary care hospital.

BACKGROUND: A wide variation exists in the patterns of pharmacotherapy among patients admitted with cardiovascular diseases. Very few studies have evaluated the potential determinants of drug utilization. Our objective was to evaluate the clinical characteristics and patterns of cardiovascular drug utilization among patients in coronary care unit (CCU) and assess the determinants of cardiovascular drug use among patients with coronary artery disease (CAD). METHODS: In this retrospective cohort study, the medical records of CCU patients were reviewed independently by two trained physicians over one year. Patients were analyzed as two groups - those with CAD and without CAD. Multivariate logistic regression was done to identify the determinants of cardiovascular drug utilization in the CAD group. RESULTS: Of 574 patients, 65% were males, 57% were <60 years. The five commonly prescribed drug classes were platelet inhibitors (88.7%), statins (76.3%), ACE-inhibitors/Angiotensin receptor blockers (72%), beta-blockers (58%) and heparin (57%). Poly-pharmacy (>5 drugs) was noticed in 71% of patients. A majority of patients had diagnosis of CAD (72.6%). CAD patients received significantly higher median number of drugs and had longer duration of CCU stay (p < 0.0001). Renal dysfunction for ACE-inhibitors [0.18 (0.09-0.36)], ST-elevation myocardial infarction for calcium channel blockers [0.29 (0.09-0.93)] and brady-arrhythmias for beta-blockers [0.3 (0.2-0.7)] were identified as determinants of decreased drug use in CAD group. CONCLUSION: Predominance of male gender, age <60 and poly-pharmacy was observed in CCU. Antithrombotics, statins, ACE-inhibitors/Angiotensin receptor blockers and beta-blockers were the most frequently prescribed drugs. Clinical co-morbidities (renal dysfunction, arrhythmias) decreased the utilization of ACE-inhibitors, beta-blockers among CAD patients.