A Non-interventional Study to Assess the Impact of Clinical Decision Support Systems Included in Electronic Health Records on Compliance With Guidelines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66,166
- 试验地点
- 2
- 主要终点
- Percentage of patients who underwent BNP/NT-proBNP test and/or echocardiography basic diagnostic tests and, consequently, improved CHF detection rates
研究概览
简要总结
A non--interventional study to assess the impact of clinical decision support systems included in electronic health records on compliance with guidelines, including routing of patients with CHF, follow-up care, prescription and dose titration of medicinal products.
详细描述
Circulatory system diseases are the leading cause of death in the Russian Federation. Ischemic heart disease (IHD) constitutes the largest share of circulatory system disease mortality, and also among the active working age population. According to the Federal State Statistics Service, IHD accounts for 54.2% in the structure of circulatory system disease mortality in the Russian Federation in 2020.
One of the most hazardous components of IHD is acute coronary syndrome (ACS). It is ACS that is one of the most common causes of CHD. In Russia, about 520,000 cases of ACS are recorded annually.
Chronic heart failure (CHF) is at the end of the cardiovascular disease continuum, which is characterized by a significant increase in overall and cardiovascular mortality risks. Therefore, a poor prognosis in this patient population, a high frequency of hospitalizations and a steady increase in the number of patients due to the population aging make CHF one of the priority areas for modern cardiology.
The most common cause of CHF is myocardial infarction. And, on the other hand, in about 20% of cases, acute myocardial infarction (AMI) is complicated by CHF, despite the success of reperfusion therapy. This patient group requires special attention. The mortality rates in patients with MI and HF are more than 10 times greater than in patients with MI without HF.
According to the guidelines for CHF 2020 approved by the Scientific and Practical Council of the Ministry of Health of Russia, the average annual mortality rate among patients with I-IV FC CHF in the Russian Federation is 6%, while in patients with clinically significant CHF, it is 12%. According to the EPOCH study data, it is known that the total mortality risk in CHF of any functional class (FC) is more than 10 times greater compared to the total mortality risk in the population of respondents without CHF, and the average life expectancy in patients with I-II FC and III-IV FC CHF is 7.8 and 4.8 years, respectively. Therefore, the scientific community agrees that mortality in patients with CHF is still high, and the rates of decline are insufficient. Consequently, the need for strategy development to reduce the demographic and financial losses from CHF is recognized in many countries, and the issues of implementing new technologies to reduce the mortality rates among patients with CHF are being studied and widely discussed in the literature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any cardiac diagnosis ICD-10 codes I00-I99
- •Age: ≥18 years
- •CHF stage 2a and higher and/or FC II and higher
- •The data export for analysis is carried out through obtaining the structured electronic healthcare records (SHCR) from the Vertically Integrated Medical Information System "Cardiovascular Diseases" (VIMIS CVD). Such export implies obtaining documents of patients with IHD, ACS, CVA, AF and CHF, occlusion and stenosis of carotid artery, infective endocarditis and cardiac device-related endocarditis, which are sent by the region to VIMIS CVD.
排除标准
- •1. Age: <18 years
研究组 & 干预措施
Inpatient cohort
Patients who were admitted to hospital for any cardiac diagnosis (ICD-10 codes I00-I99), with CHF of stage 2a or higher and/or FC II and higher as the primary or secondary (concomitant or as a complication) diagnosis. Index event is the earliest hospitalization for any cardiac diagnosis during which an ICD code I50.x (standard coding) and/or I11.0, I13.0, I13.2, I25.5, I42.0, I42.9, I09.9, I43.0, I43.1, I43.2, I43.8, I42.5, I42.6, I42.7, I42.8 (extended coding) is specified as a primary or secondary diagnosis, or the clinical diagnosis specify CHF of stage 2a or higher and/or FC II and higher, or according to the CDSS algorithm criteria, the patient's clinical presentation corresponds to CHF (a subcohort of patients included based on the diagnosis established by the CDSS is subject to an individual analysis).
Outpatient cohort
Patients who had an outpatient visit for any cardiac diagnosis (ICD-10 codes I00-I99), with: 1) CHF of stage 2a or higher and/or FC II and higher as the primary or secondary (concomitant or as a complication) diagnosis at the same visit. Index event is the earliest outpatient visit to a general practitioner or cardiologist for any cardiac diagnosis for which an ICD code I50.x (standard coding) and/or I11.0, I13.0, I13.2, I25.5, I42.0, I42.9, I09.9, I43.0, I43.1, I43.2, I43.8, I42.5, I42.6, I42.7, I42.8 (extended coding) is specified as a primary or secondary diagnosis, or the clinical diagnosis specify CHF of stage 2a or higher and/or FC II and higher, or according to the CDSS algorithm criteria, the patient's clinical presentation corresponds to CHF of stage 2a or higher and/or FC II and higher (a subcohort of patients included based on the diagnosis established by the CDSS is subject to an individual analysis).
结局指标
主要结局
Percentage of patients who underwent BNP/NT-proBNP test and/or echocardiography basic diagnostic tests and, consequently, improved CHF detection rates
时间窗: 12 months
To assess the effectiveness of the CDSS implementation with regard to an increase in frequency of basic diagnostic tests and, consequently, improved CHF detection rates For the inpatient cohort, the percentage will be calculated as the number of patients who underwent at least one of the above diagnostic tests or a combination of two criteria during the observation period, divided by the number of patients included in the inpatient cohort. The percentages of patients who underwent each of the tests separately (BNP/NT-proBNP or EchoCG) are calculated separately. For the outpatient cohort, the percentage will be calculated as the number of patients who underwent at least one of the above diagnostic tests or a combination of two criteria during the observation period, divided by the number of patients included in the outpatient cohort. The percentages of patients who underwent each of the tests separately (BNP/NT-proBNP or EchoCG) are calculated separately.
次要结局
- The effectiveness of the CDSS implementation with regard to improvement in follow-up care(12 months)
- The effectiveness of the CDSS implementation with regard to the performance of examination at the outpatient stage(12 months)
- The effectiveness of the CDSS implementation with regard to updating comorbidity in patients with CHF(12 months)
- Characteristic of blood pressure in patients with increased risks of CHF occurrence or its course(12 months)
- The recommended therapy at discharge(12 months)
- The effectiveness of the CDSS implementation with regard to improvement in follow-up care and patient routing(12 months)
- The effectiveness of the CDSS implementation with regard to improvement in follow-up care and patient routing per one patient-year(12 months)
- Characteristic of lipid profile and laboratory tests in patients with increased risks of CHF occurrence or its course(12 months)
- Assessment of the data in the EHR for the index event and for the last reported case of health care delivery during the follow-up.(12 months)
- The basic socio-demographic characteristics and lifestyle peculiarities in CHF patients (gender)(12 months)
- The performance of diagnostic procedures in the hospital setting (index hospitalization)(12 months)
- The effectiveness of the CDSS implementation with regard to improvement in the prescription and therapy continuity at the outpatient stage(12 months)
- The effectiveness of the CDSS implementation with regard to improvement in clinical outcomes of patients with CHF(12 months)
- The effectiveness of the CDSS implementation with regard to monitoring the provision of patients with CHF(12 months)
- The basic socio-demographic characteristics and lifestyle peculiarities in CHF patients (age)(12 months)
- The basic socio-demographic characteristics and lifestyle peculiarities in CHF patients (Weight, BMI)(12 months)
- The effectiveness of the CDSS implementation with regard to the performance of diagnostic tests at the outpatient stage(12 months)
- Characteristic of heart rate in patients with increased risks of CHF occurrence or its course(12 months)
研究者
Sergey Nikolaevich Tereschenko
Head of the Department of Myocardial diseases and Heart failure, MD, PhD, professor
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation