Dataset Information

Prospective randomised trial examining the impact of an educational intervention versus usual care on anticoagulation therapy control based on an SAMe-TT₂R₂ score-guided strategy in anticoagulant-naive Thai patients with atrial fibrillation (TREATS-AF): a study protocol.

ABSTRACT:

Introduction

The burden of atrial fibrillation (AF) in Thailand is high and associated with increased morbidity, mortality and healthcare costs. Vitamin K antagonists (eg, warfarin), commonly used for stroke prevention in patients with AF in Thailand, are effective but are often suboptimally controlled. We aim to evaluate the impact of an SAMe-TT₂R₂ score-guided strategy and educational intervention compared to usual care on anticoagulation control expressed by the time in therapeutic range (TTR) at 12 months, in anticoagulant-naïve Thai patients with AF.

Methods and analysis

Multicentre, open-label, parallel-group, randomised controlled trial conducted in Thailand among adult patients (age: 18 years) with AF who are anticoagulant naïve. Patients will be randomised to one of two groups; an SAMe-TT₂R₂ score-guided strategy with educational intervention and usual care versus usual care alone. The planned follow-up period is 12 months. The primary outcome is TTR at 12 months. Secondary outcomes include: (1) TTR at 6 months; (2) thromboembolic and bleeding events at 12 months; (3) composite major adverse cardiovascular events at 12 months; (4) change in patients' knowledge of AF between baseline and 6 months and 12 months; (5) cost effectiveness; (6) quality of life at baseline, 6 months and 12 months using EQ-5D-5L (Thai version) and (7) patient satisfaction/perceptions of the TREAT intervention. An embedded qualitative study will assess patient perceptions of the TREAT intervention.

Ethics and dissemination

The study has been approved by the Ethical Review Committee, Ministry of Public Health of Thailand, and registered in the Thai Clinical Trials Registry. The results of this trial will be submitted for publication in a peer-reviewed journal. Participants will be informed via a link to a preview of the publication. A lay summary will also be provided to all participants prior to publication.

Trial registration number

TCTR20180711003.

SUBMITTER: Phrommintikul A

PROVIDER: S-EPMC8506852 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The incidence of atrial fibrillation (AF) is progressively increasing, in line with the aging of the population and with the increase in chronic diseases. The care burden of the disease and above all to its consequences (i.e. ischaemic stroke and heart failure) significantly impacts the various health systems with forecasts of exponential increase in the near future. Clinical forms of AF, i.e. those diagnosed with electrocardiogram, have a clear correlation with systemic embolic events and also with a reduction in survival. Thromboembolic prophylaxis in these patients, with anticoagulant drugs, has in fact been shown to greatly reduce the incidence of ischaemic stroke and improve survival. In recent decades, the widespread use of therapeutic intra-cardiac devices, which allow constant and continuous monitoring of myocardial electrical activity, is bringing to light a large number of atrial high rate episodes (AHREs), which are not associated with clinical manifestation. The incidence of these findings grows linearly with the duration of the observation. More independent studies have shown that AHREs are associated with a risk of stroke that is higher (about double) than controls but significantly lower than in patients with manifest AF. However, taking into consideration patients with ischaemic stroke and wearers of implantable devices, no temporal correlation emerged between the incidence of the ischaemic episode and arrhythmia. The presence of AHRE is associated with an approximately six-fold increase in the incidence of clinical AF but only a minority of these patients meet the criteria for prescribing anticoagulation. Pending the publication of the studies still in progress, the European Society of Cardiology guidelines for the treatment of AF recommend considering the initiation of anticoagulant therapy in patients with long-lasting AHRE (> 24 h) associated with a high embolic risk. In patients with episodes of shorter duration (1-24 h), especially if with high burden, anticoagulant therapy can be considered in case of very high embolic risk (e.g. secondary prevention, CHADVASc ≥ 3).

Project description:Background Only 50% of eligible atrial fibrillation ( AF ) patients receive anticoagulation ( AC ). Feasibility and effectiveness of electronic medical record (EMR)-based interventions to profile and raise provider AC percentage is poorly understood. The SUPPORT-AF (Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF) study aims to improve rates of adherence to AC guidelines by developing and delivering supportive tools based on the EMR to providers treating patients with AF. Methods and Results We emailed cardiologists and community-based primary care providers affiliated with our institution reports of their AC percentage relative to peers. We also sent an electronic medical record-based message to these providers the day before an appointment with an atrial fibrillation patient who was eligible but not receiving AC . The electronic medical record message asked the provider to discuss AC with the patient if he or she deemed it appropriate. To assess feasibility, we tracked provider review of our correspondence. We also tracked the change in AC for intervention providers relative to alternate primary care providers not receiving our intervention. We identified 3786, 1054, and 566 patients cared for by 49 cardiology providers, 90 community-based primary care providers, and 88 control providers, respectively. At baseline, the percentage of AC was 71.3%, 63.5%, and 58.3% for these 3 respective groups. Intervention providers reviewed our e-mails and electronic medical record messages 45% and 96% of the time, respectively. For providers responding, patient refusal was the most common reason for patients not being on AC (21%) followed by high bleeding risk (19%). At follow-up 10 weeks later, change in AC was no different for either cardiology or community-based primary care providers relative to controls (0.2% lower and 0.01% higher, respectively). Conclusions Our intervention profiling AC was feasible, but not sufficient to increase AC in our population.

Dataset Information

Prospective randomised trial examining the impact of an educational intervention versus usual care on anticoagulation therapy control based on an SAMe-TT₂R₂ score-guided strategy in anticoagulant-naive Thai patients with atrial fibrillation (TREATS-AF): a study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Prospective randomised trial examining the impact of an educational intervention versus usual care on anticoagulation therapy control based on an SAMe-TT2R2 score-guided strategy in anticoagulant-naive Thai patients with atrial fibrillation (TREATS-AF): a study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Prospective randomised trial examining the impact of an educational intervention versus usual care on anticoagulation therapy control based on an SAMe-TT₂R₂ score-guided strategy in anticoagulant-naive Thai patients with atrial fibrillation (TREATS-AF): a study protocol.