Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248658
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-22
Brief Title:
Assessment of the Impact of Clinical Decision Support Systems Included in Electronic Health Records
Sponsor:
National Medical Research Center for Cardiology Ministry of Health of Russian Federation
Organization:
National Medical Research Center for Cardiology Ministry of Health of Russian Federation
Study Overview
Official Title:
A Non-interventional Study to Assess the Impact of Clinical Decision Support Systems Included in Electronic Health Records on Compliance With Guidelines
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 542 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 520000 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 78 and 48 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 438 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 778 compared to 937 in patients without CHF and CHD difference 159 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 46 16 was more common than in patients with low comorbidity 234 and 75 of cases respectively p 0007
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
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 520000 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 78 and 48 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 438 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 778 compared to 937 in patients without CHF and CHD difference 159 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 46 16 was more common than in patients with low comorbidity 234 and 75 of cases respectively p 0007
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None