Assessment of the Impact of Clinical Decision Support Systems Included in Electronic Health Records

NCT06248658 | Completed DMC

• 1 other identifier: 20240122
• Study Type: observational
• Target: 66,166
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure (CHF)

Keywords

heart failure; clinical decision support systems; guidelines

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who underwent BNP/NT-proBNP test and/or echocardiography basic diagnostic tests and, consequently, improved CHF detection rates

  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.

  12 months

Secondary Outcomes (18)

• 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 recommended therapy at discharge

  12 months

• The effectiveness of the CDSS implementation with regard to improvement in follow-up care

  12 months

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• \. Age: \<18 years

Sponsors & Collaborators

• National Society for the Study of Heart Failure and Myocardial Diseases: collaborator
• Novartis: collaborator
• National Medical Research Center for Cardiology, Ministry of Health of Russian Federation: lead

Study Sites (1)

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Moscow, Russia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 8, 2024
• Study Start: October 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: May 31, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

RU (1)