Clinical trial NCT05021575: Effects of COVID-19 Pandemic on a Health Care System: Case Study of the CirculatORy System in LiThuania
Official title: Effects of COVID-19 Pandemic on Personal and Public Health and Functioning of Health Care System: Case Study of the CirculatORy System in LiThuania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: cardiovascular diseases
COVID-19
health care system
cardiovascular mortality
hospitalizations
outpatient care
cardiovascular interventions
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Institute of Hygiene, Lithuania
name: National Health Insurance Fund under the Ministry of Health, Lithuania
name: Vilnius University Hospital Santaros Klinikos
First posted: 2021-08-25
Enrollment: 839678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of outpatient care visits for cardiovascular reasons in Lithuania in 2019 and 2020
timeFrame: 2 years
measure: Number of cardiovascular hospitalisations in Lithuania in 2019 and 2020
timeFrame: 2 years
measure: Cardiovascular mortality rates in Lithuania in 2019 and 2020
timeFrame: 2 years
Secondary outcomes:
measure: Evaluation of sex and age differences in changes of CV care provision and CV deaths during the pandemic and comparison between 2019 and 2020
timeFrame: 2 years
measure: In-hospital mortality rates in Lithuania in 2019 and 2020
timeFrame: 2 years
measure: Comparison of distribution of death places in Lithuania in 2019 and 2020
timeFrame: 2 years
measure: 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
timeFrame: 3 months
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Institute of Hygiene
city: Vilnius
country: Lithuania
facility: National Health Insurance Fund under the Ministry of Health, Lithuania
city: Vilnius
country: Lithuania
facility: Vilnius University
Study officials:
References:
citation: Celutkiene J, Cerlinskaite-Bajore K, Bajoras V, Visinskiene R, Lizaitis M, Budrys P, Buivydas R, Gurevicius R, Serpytis P, Davidavicius G. Collateral effect of the COVID-19 pandemic on cardiology service provision and cardiovascular mortality in a population-based study: COVID-COR-LT. Clin Res Cardiol. 2022 Oct;111(10):1130-1146. doi: 10.1007/s00392-022-02033-y. Epub 2022 May 12.