Clinical trial NCT06248658: Assessment of the Impact of Clinical Decision Support Systems Included in Electronic Health Records
Official title: A Non-interventional Study to Assess the Impact of Clinical Decision Support Systems Included in Electronic Health Records on Compliance With Guidelines
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Heart Failure (CHF)
Keywords: heart failure
clinical decision support systems
guidelines
Lead sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Sponsor class: OTHER_GOV
Collaborators: name: National Society for the Study of Heart Failure and Myocardial Diseases
name: Novartis
First posted: 2024-02-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Currently, all regional health clinics use the regional HIS to collect clinical data on patients of very high-risk groups based on the data of electronic health records.

It is expected that the current study will include patients being in follow-up care, with a history of cerebrovascular accident, myocardial infarction and coronary artery bypass grafting, Arterial angioplasty with stenting and catheter ablation for CVD, within 2 years after the diagnosis date

Brief summary: 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.

Detailed description: 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.

High comorbidity and numerous hospitalizations turn the patients with heart failure (HF) into "super consumers" of the healthcare system resources. Comorbid CHF makes the disease burden even greater. For example, patients with a double burden of CKD and CHF (the most common comorbid combination, 43.8%) demonstrate unacceptably high rates of symptom burden, hospitalization rates, and mortality. The adjusted survival probability in patients with CHF and CKD after 2 years is 77.8% compared to 93.7% in patients without CHF and CHD (difference: 15.9%). One of the studies of CHF comorbidity demonstrated that atrial fibrillation (AF) in highly comorbid patients (average number of disease areas per patient with CHF: 4.6 ± 1.6) was more common than in patients with low comorbidity (23.4% and 7.5% of cases, respectively; p = 0.007).

Existing innovative therapeutic approaches in combination with the introduction of components of the CHF patient service can significantly influence the prognosis and reduce the burden on the healthcare system. However, in real-world clinical practice in the Russian Federation, the percentage of patients with HF who receive innovative drug therapy and the frequency of achieving target doses of disease modifying therapies are still low.

To reduce the circulatory system disease mortality, the Government of the Russian Federation has developed and is implementing the Federal Project "Combating Cardiovascular Diseases" and regional programs under the same name. They include the Program for Preferential Drug Provision for patients with AMI, CVA, as well as if they had CABG, PCI, and RFA procedures within the first two years of follow-up care. Consequently, the importance of Digital Systems is increasing, since they help identify such patients and perform their therapy in full.

Possible reasons for the current situation include low effectiveness of organizational approaches, in particular, a low percentage of patients visiting outpatient facilities after discharge, non-compliance with follow-up care timing, extremely low frequency of laboratory tests and diagnostic procedures, including a test for NT-proBNP level.

Monitoring of key clinical parameters of CHF patients, given medical therapy, assessment of follow-up care effectiveness, evaluation of consumed healthcare system resources using electronic health records (EHR) is one of the effective approaches to better adherence of healthcare professionals (HCPs) to the Guidelines, improved quality of health care, which, in its turn, can help improve the prognosis and to achieve the target mortality rates in circulatory system diseases. However, despite the pronounced success in the fight against circulatory system diseases, including CHF, the use of EHR systems as a tool for assessing the effectiveness of HF patient management and collecting statistical data is still unexplored. The EHR systems, which are used for collection and analysis of data on HF patients, have been introduced by healthcare providers in several regions in the Russian Federation.

In this study, the implementation strategy involves provision HCPs (primary care physicians and cardiologists) with access to the service that allows analyzing the data on routing and key clinical parameters of CHF patients.

The primary objective of this study is to assess the effectiveness of the implementation of the CDSS (clinical decision support system) aimed at improving the HCP compliance with the main provisions of the guidelines for heart failure in real-world clinical practice in order to enhance the effectiveness of this patient category management and improve clinical outcomes in the pilot regions of the Russian Federation.

Eligibility criteria: Inclusion Criteria:

1. Any cardiac diagnosis ICD-10 codes I00-I99
2. Age: ≥18 years
3. CHF stage 2a and higher and/or FC II and higher
4. 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.

Exclusion Criteria:

1. Age: \<18 years

Primary outcomes:
measure: Percentage of patients who underwent BNP/NT-proBNP test and/or echocardiography basic diagnostic tests and, consequently, improved CHF detection rates
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: The basic socio-demographic characteristics and lifestyle peculiarities in CHF patients (gender)
timeFrame: 12 months
measure: The performance of diagnostic procedures in the hospital setting (index hospitalization)
timeFrame: 12 months
measure: The recommended therapy at discharge
timeFrame: 12 months
measure: The effectiveness of the CDSS implementation with regard to improvement in follow-up care
timeFrame: 12 months
measure: The effectiveness of the CDSS implementation with regard to improvement in follow-up care and patient routing
timeFrame: 12 months
measure: The effectiveness of the CDSS implementation with regard to the performance of examination at the outpatient stage
timeFrame: 12 months
measure: The effectiveness of the CDSS implementation with regard to improvement in the prescription and therapy continuity at the outpatient stage
timeFrame: 12 months
measure: The effectiveness of the CDSS implementation with regard to updating comorbidity in patients with CHF
timeFrame: 12 months
measure: The effectiveness of the CDSS implementation with regard to improvement in clinical outcomes of patients with CHF
timeFrame: 12 months
measure: The effectiveness of the CDSS implementation with regard to monitoring the provision of patients with CHF
timeFrame: 12 months
measure: Characteristic of blood pressure in patients with increased risks of CHF occurrence or its course
timeFrame: 12 months
measure: The effectiveness of the CDSS implementation with regard to improvement in follow-up care and patient routing per one patient-year
timeFrame: 12 months
measure: The effectiveness of the CDSS implementation with regard to the performance of diagnostic tests at the outpatient stage
timeFrame: 12 months
measure: Characteristic of heart rate in patients with increased risks of CHF occurrence or its course
timeFrame: 12 months
measure: Characteristic of lipid profile and laboratory tests in patients with increased risks of CHF occurrence or its course
timeFrame: 12 months
measure: The basic socio-demographic characteristics and lifestyle peculiarities in CHF patients (age)
timeFrame: 12 months
measure: The basic socio-demographic characteristics and lifestyle peculiarities in CHF patients (Weight, BMI)
timeFrame: 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Study officials:
References: