Effects of COVID-19 Pandemic on a Health Care System: Case Study of the CirculatORy System in LiThuania (COVID-COR-LT)

August 25, 2021 updated by: Jelena Čelutkienė, Vilnius University

Effects of COVID-19 Pandemic on Personal and Public Health and Functioning of Health Care System: Case Study of the CirculatORy System in LiThuania

Coronavirus disease of 2019 (COVID-19) affected the health care systems all around the world. The collateral damage of the pandemic on the cardiovascular (CV) care and CV mortality has been noticed and reported early. In Lithuania, first quarantine measurements were introduced on 16th March and lifted on 16th June of 2020, limiting contact appointments to urgent care only. This led to a substantial proportion of routine cardiovascular appointments, diagnostic and therapeutic procedures being cancelled and greatly limited the availability of cardiovascular care. The prognostic impact of this has not been appropriately analysed. Also, comprehensive analyses of the changes in national CV services, including outpatient care and hospitalisations and CV mortality, during different periods of the pandemic (during first and second waves and in between) are scarce. The objectives of this population-based study were: (1) to assess the impact of the COVID-19 pandemic on CV care (2) to compare rates of outpatient care visits and hospitalisations of cardiovascular patients in different periods of 2019 and 2020 (3) to compare the rates of CV mortality in Lithuania in different periods of 2019 and 2020 (4) to investigate sex and age differences in CV care and CV mortality

Study Overview

Detailed Description

COVID-19 pandemic has greatly affected the world and changed health care in almost every country. During the spring of 2020, first pandemic wave was of different scale in different countries. In countries affected by the virus the most, a majority of the studies focused on the direct impact of COVID-19 on community health. It was noticed promptly that the novel virus is especially high-risk for patients with cardiovascular comorbidities. Furthermore, the collateral damage of COVID-19 pandemic on the provision of cardiovascular (CV) care and cardiovascular mortality was also reported early in several nationwide and selected cohort studies. The research was mostly focused on acute cardiovascular conditions; changes in hospital admissions and early mortality after myocardial infarction were also often analysed. Meanwhile, a substantial proportion of routine appointments, diagnostic and therapeutic procedures was cancelled. Data on the changes in total national CV services, including out- and in-patient health care facilities, acute and chronic conditions, during the outbreak, between the two pandemic waves and onwards are scarce. First case of COVID-19 in Lithuania was confirmed on 28th February 2020. First nationwide quarantine was introduced by Lithuanian government on 16th March and ended on 16th June. In that period, although Lithuania was reported among the least affected countries according to World Health Organization - 1 773 COVID-19 cases were recorded and 86 patients (of whom 10 patients died from other causes after testing positive for SARS-CoV-2) had died before the end of quarantine, Lithuanian government limited contact appointments to urgent conditions only. The utmost efforts to provide triage, follow-up care by telephone call and e-prescriptions were recommended. This greatly affected availability of cardiovascular care. The second pandemic wave in Lithuania was substantially more severe. Consequently, the second nationwide quarantine was implemented on 7th November, 2020. Contact appointments were not limited by the government; however, the scope of CV care was again negatively affected, mostly by the strained health care system.

We analysed the indirect impact of the COVID-19 pandemic in a country, which was hit by two very different pandemic waves. The objectives of this population-based study were: (1) to assess the impact of the COVID-19 pandemic on CV care (2) to compare rates of outpatient care visits and hospitalisations of cardiovascular patients in different periods of 2019 and 2020 (3) to compare the rates of CV mortality in Lithuania in different periods of 2019 and 2020 (4) to investigate sex and age differences in CV care and CV mortality

Study Type

Observational

Enrollment (Actual)

839678

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vilnius, Lithuania
        • Vilnius University
      • Vilnius, Lithuania
        • Institute of Hygiene
      • Vilnius, Lithuania
        • National Health Insurance Fund under the Ministry of Health, Lithuania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18 years old) included in either National Health Insurance Fund outpatient and hospitalisation registries related to cardiovascular diseases from 1st January 2019 to 30th November 2020 or in Causes of Death Registry from Institute of Hygiene with cardiovascular diagnoses from 1st January 2019 to 31st December 2020.

Description

Inclusion Criteria:

  • ≥18 years old adult patients
  • Included in either National Health Insurance Fund outpatient and hospitalisation registries related to cardiovascular diseases from 1st January 2019 to 30th November 2020
  • Included in Causes of Death Registry from Institute of Hygiene with cardiovascular diagnoses from 1st January 2019 to 31st December 2020.

Exclusion Criteria:

  • Cases, when sex was not available were excluded from sex differences analysis.
  • Death certificates where place of death was unspecified were excluded from death place analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2020
Data on outpatient care, hospitalisation and cardiovascular mortality were collected for the year 2020.

Outpatient data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health.

Outpatient data related to cardiovascular diseases (CVD) were collected as described:

  1. data on visits were collected using ICD-10 codes I00-I99 and other CVD related codes (e.g., certain Z, Q codes, J81.0, R57.0)
  2. data were collected from CVD prevention program
  3. data on interventional cardiology were collected from day care facility regardless of the diagnosis.

Date of the visit, patient age, sex and municipality, service level (primary, secondary or tertiary), type of service and main diagnosis were recorded.

Hospitalisation data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health.

Data on hospitalisation were collected if any of the diagnoses (principal or secondary) were in I00-I99 range. Hospitalisation data covered hospitalisation date, patient age, sex, municipality and outcome. Data on cardiovascular procedures performed during hospitalisations included date of the procedure and ACHI (Australian Classification of Health Interventions) code.

Data on cardiovascular mortality were obtained from death certificates provided by Causes of Death Registry from Institute of Hygiene and covered the period from 1 January to 31 December of the analysed year. Death certificates were included in the study when cause of death was adjudicated to be in I00-I99 range. Date and place of death (hospital, home, other or unspecified), patient age and sex were recorded.
Demographic, clinical and percutaneous coronary intervention (PCI) related data were collected from 1st March to 30th June of the analysed year. The timing of the chest pain onset, call for medical help, first medical contact (FMC), arrival to PCI centre, and PCI procedure were analysed.
2019
Data on outpatient care, hospitalisation and cardiovascular mortality were collected for the year 2019.

Outpatient data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health.

Outpatient data related to cardiovascular diseases (CVD) were collected as described:

  1. data on visits were collected using ICD-10 codes I00-I99 and other CVD related codes (e.g., certain Z, Q codes, J81.0, R57.0)
  2. data were collected from CVD prevention program
  3. data on interventional cardiology were collected from day care facility regardless of the diagnosis.

Date of the visit, patient age, sex and municipality, service level (primary, secondary or tertiary), type of service and main diagnosis were recorded.

Hospitalisation data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health.

Data on hospitalisation were collected if any of the diagnoses (principal or secondary) were in I00-I99 range. Hospitalisation data covered hospitalisation date, patient age, sex, municipality and outcome. Data on cardiovascular procedures performed during hospitalisations included date of the procedure and ACHI (Australian Classification of Health Interventions) code.

Data on cardiovascular mortality were obtained from death certificates provided by Causes of Death Registry from Institute of Hygiene and covered the period from 1 January to 31 December of the analysed year. Death certificates were included in the study when cause of death was adjudicated to be in I00-I99 range. Date and place of death (hospital, home, other or unspecified), patient age and sex were recorded.
Demographic, clinical and percutaneous coronary intervention (PCI) related data were collected from 1st March to 30th June of the analysed year. The timing of the chest pain onset, call for medical help, first medical contact (FMC), arrival to PCI centre, and PCI procedure were analysed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of outpatient care visits for cardiovascular reasons in Lithuania in 2019 and 2020
Time Frame: 2 years
Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
2 years
Number of cardiovascular hospitalisations in Lithuania in 2019 and 2020
Time Frame: 2 years
Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
2 years
Cardiovascular mortality rates in Lithuania in 2019 and 2020
Time Frame: 2 years
Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of sex and age differences in changes of CV care provision and CV deaths during the pandemic and comparison between 2019 and 2020
Time Frame: 2 years
Comparison of cardiovascular outpatient care visits, hospitalisation numbers and cardiovascular mortality rates between men and women and between different age groups.
2 years
In-hospital mortality rates in Lithuania in 2019 and 2020
Time Frame: 2 years
Comparison of mortality rate in hospitalised patients in Lithuania between 2019 and 2020
2 years
Comparison of distribution of death places in Lithuania in 2019 and 2020
Time Frame: 2 years
Assessing the differences in the death places written in the death certificates of the people deceased from cardiovascular causes between 2019 and 2020
2 years
Comparison of all-cause mortality during the hospital stay and at 3 months of follow-up in patients presenting to a tertiary care centre with acute coronary syndrome during the first quarantine in 2020 and in a corresponding period of 2019
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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