Impact of COVID-19 Outbreak on Non-COVID-19 Patients (NoCOVImpact)

Impact of the COVID-19 Pandemic on the Morbidity and Mortality of Non-COVID-19 Patients Hospitalized Around the Epidemic Peak in the Geneva Area (Switzerland) (No COVID Impact)

The Geneva Canton organized the health crisis of the COVID-19 epidemic around the care of COVID patients at the University Hospital (HUG), by moving the care of non-COVID patients to private hospitals of the canton. The COVID epidemic appears to have been associated with a decrease in consultations and care for non-COVID patients. An excess of morbidity and mortality (non-COVID) would be possible during or after the epidemic in connection with this "under-medicalization" of non-COVID patients.

The aim of this study is to measure and analyze the impact on the morbidity and mortality of inpatients during and after the COVID-19 epidemic in the adult inpatient wards of HUG and township hospitals / clinics.

Study Overview

• Status: Enrolling by invitation
• Conditions: COVID-19

Detailed Description

The analysis of the various results will be carried out on all HUGs and on the various hospitals / clinics in the canton.

A survival analysis for the outcome of death or rehospitalization will be performed, with a comparison according to each period.

After epidemy evolution, finally, the outcomes will be compared between periods pre-COVID (from 01 march 2019 to 28 february 2020) versus per-COVID (01 march 2020 to 28 february 2022), and versus post-COVID (01 march 2022 to 28 february 2023). And comparaison would be performed between periods during the wave (per-wave) versus periods inter-wave.

A description will be made in number (%) for numerical data and in median (IQR) for quantitative data. Univariate comparisons between the different periods will be carried out by statistical tests, parametric or not, adapted according to the data (Chi2 or Fisher's test for qualitative data, Student's test or Mann-Whitney-Wilcoxon for quantitative data). Statistical significance will be retained in the event of p <0.05.

Multivariate analysis will be performed by logistic regression for the main outcome and by cox model for survival analysis. Different variables will be included in the models, including data on gender, age and comorbidity, as well as any variable having a difference with p <0.2 in univariate analysis.

Secondary analyzes will be carried out by pathology (as the main diagnosis) according to the specific results defined for each situation. In retrospective analysis, these specific data will be relatively limited on the HUG area of full analysis brings together around total of 240,000 hospital stays. The main outcome data will be complete with no missing data. On the other hand, since this is retrospective data, it is possible that some important variables are missing. In this case, other patient data with missing data will not be included in the multivariate analyzes. In the event of missing data greater than 10%, a second sensitivity analysis may be performed after replacing the missing data with a multiple imputation method.

• Study Type: Observational
• Enrollment (Anticipated): 240000

Contacts and Locations

Study Locations

• Switzerland
  • Canton De Genève
    • Geneva, Canton De Genève, Switzerland, 1255
      • Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients hospitalized in Geneva hospital or clinic from the 1st march 2019 to 28 february 2023.

Description

Inclusion Criteria:

• Patient hospitalized in an adult department
• During the pre-period-COVID-19 period, the per-COVID-19 or the post-COVID-19 periods ie from the 1st march 2019 to 28 february 2023.

Exclusion Criteria:

• Patients who have been hospitalized for COVID-19 infection
• Patients hospitalized in the Department of Adolescent Woman and Child, Department of Psychiatry or Intensive Care Department during the same periods.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
pre-COVID-19 period; Patients hospitalized between 1.3.2019 and 28.02.2020
per-COVID-19 period; Patients hospitalized between 1.3.2020 and 28.02.2022
post-COVID-19 period; Patients hospitalized between 1.3.2022 and 28.02.2023

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-hospital mortality	death during hospitalization of each patient	Assessed at the discharge date, up to 3 months after admission
composite outcome (worsening during hospitalization)	intra-hospital mortality and / or transfer to intensive care and / or transfer to intermediate care during hospitalization	At the discharge date of hospitalization, up to 3 months after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologies leading to hospitalization	Primary and secondary diagnosis during hospitalization (CIM10 codes)	At the discharge date of hospitalization, up to 3 months after admission
overall mortality at 3 months (90 days)	intra or extra hospital mortality : death occuring during hospitalization or after	within the 3 months after the admission date
Potentially avoidable readmission rate	Potentially avoidable readmission according to SQLape algorithm (http://www.sqlape.com/READMISSIONS.htm)	During the 30 days after the patient's discharge
mortality rate by pathology at 3 months	mortality for each top 10 of pathologies (intra or extra hospital mortality for each pathology)	within the 3 months after the admission date
length of stay	Hospital length of stay (Time between admission date and discharge date)	At the discharge date of hospitalization, up to 3 months after admission
rate of transfer to intermediate or intensive care	Number of patients with transfer to intensive or intermediate care during hospitalization	At the discharge date, up to 3 months after admission
rate of transfer to rehabilitation care	Number of patients with rehabilitation transfer during hospitalization	At the discharge date of acute care, up to 3 months after admission
specific gravity outcomes for patients with pneumonia : CURB 65 scale (Confusion, Urea, Respiratory rate, Blood pressure, Age [>65])	CURB65 scale: min-max 0 to 5 points [5 points : worse outcome]	At the acute care admission
specific gravity outcomes for patients with cardiac Failure : KILLIP class	KILLIP class (class 1 to 4) [class 4 : worse outcome]. The KILLIP classification is a system used in individuals with an acute myocardial infarction (heart attack), taking into account physical examination and the development of heart failure in order to predict and stratify their risk of mortality.	At the acute care admission
specific gravity outcomes for patients with cardiac Failure : Weight variation	Weight variation : variation of weight at the admission compared to the basis weight	At the acute care admission
specific gravity outcomes for patients with cardiac Failure or lung disease	FIO2 (% O2 prescribed): Fraction of inspired oxygen	At the acute care admission
Leukocytes serum level	Giga / litre	At the acute care admission
Polynuclear neutrophils serum level	Giga / litre	At the acute care admission
Lymphocytes serum level	Giga / litre	At the acute care admission
Hemoglobin serum level	gram/litre	At the acute care admission
Thrombocytes serum level	Giga / litre	At the acute care admission
Quick serum level	in %	At the acute care admission
INR (International Normalized Ratio)	No unit	At the acute care admission
fibrinogen serum level	gram/litre	At the acute care admission
PTT serum level (partial Thromboplastin time)	in second	At the acute care admission
D-Dimers serum level	ng / ml	At the acute care admission
glucose serum level	mmol / litre	At the acute care admission
glycated hemoglobin serum level (HbA1C)	in %	At the acute care admission
C-reactive protein serum level (CRP)	mg / litre	At the acute care admission
sodium serum level	mmol / l	At the acute care admission
potassium serum level	mmol / l	At the acute care admission
chlorides serum level	mmol / l	At the acute care admission
calculated osmolality serum level	mOsm / kg	At the acute care admission
Phosphates serum level	mmol / l	At the acute care admission
corrected calcium serum level	mmol / l	At the acute care admission
urea serum level	mmol / l	At the acute care admission
creatinine serum level	µmol / l	At the acute care admission
eGFR (CKD-EPI) serum level	ml / min / 1.73m2	At the acute care admission
albumin serum level	g / l	At the acute care admission
prealbumin serum level	mg / l	At the acute care admission
cyanocobalamin serum level	pmol / l	At the acute care admission
folate serum level	nmol / l	At the acute care admission
25-hydroxy vitamin D (D2 + D3) serum level	nmol / l	At the acute care admission
proBNP (Brain Natriuretic Peptid) serum level	ng / l	At the acute care admission
Ultra sensitive Troponin T serum level	ng / l	At the acute care admission
ASAT (aspartate transaminase) serum level	U / l	At the acute care admission
ALAT (alanine aminotransferase) serum level	U / l	At the acute care admission
Alkaline phosphatases serum level	U / l	At the acute care admission
Gamma glutamyl transpeptidase. serum level	U / l	At the acute care admission
Total bilirubin serum level	µmol / l	At the acute care admission
ferritin serum level	µg / l	At the acute care admission
TSH serum level	mU / l	At the acute care admission
Arterial pH	No unit	At the acute care admission
Arterial pCO2 (carbon dioxide partial pressure)	kPa	At the acute care admission
Arterial pO2 (oxygen partial pressure)	kPa	At the acute care admission
Arterial lactate	mmol / l	At the acute care admission
Arterial HCO3 (bicarbonate)	mmol / l	At the acute care admission
protein serum level	g / l	At the acute care admission
Arterial pressure	Arterial pression (min-max), in mmHg	At the acute care admission
cardiac rates	Bat/mn	At the acute care admission
respiratory rates	/mn	At the acute care admission
temperature	Celsius degrees	At the acute care admission
oxygen saturation	Percutaneous oxygen saturation (in %)	At the acute care admission
peak flow	L/mn	At the acute care admission
specific scales : VAS of pain	Visual analog Pain scale (min-max : 1 to 10 [worse outcome])	At the acute care admission
specific scales : FIM	Functional Independence Measure (min-max : 18 [worse outcome]) to 126)	At the acute care admission
specific scales : SOFA score	Sequential Organ Failure Assessment Score (min-max : 0 to 24 [worse outcome])	At the acute care admission
specific scales : MNA	Mini Nutritional Assessment (min-max : 0 [worse outcome] to 14)	At the acute care admission
specific scales : NRS	Nutrition Risk Screening (min-max : 0 to 12 [worse outcome])	At the acute care admission
serum or urine positive bacteriologic sample	number of positive hemoculture or urinary cultures	At the acute care admission or during hospitalization
Patient questionnaire	Questionnaire asking each patient if they had difficulty seeing a doctor before their hospitalization and if they delayed their hospitalization due to the COVID-19 crisis.	At the discharge date of hospitalization, up to 3 months after admission

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: La Tour Hospital
• Investigators: Principal Investigator: Jerome Stirnemann, MD, University Hospital, Geneva

Publications and helpful links

General Publications

• Killip T 3rd, Kimball JT. Treatment of myocardial infarction in a coronary care unit. A two year experience with 250 patients. Am J Cardiol. 1967 Oct;20(4):457-64. doi: 10.1016/0002-9149(67)90023-9. No abstract available.
• Welt FGP, Shah PB, Aronow HD, Bortnick AE, Henry TD, Sherwood MW, Young MN, Davidson LJ, Kadavath S, Mahmud E, Kirtane AJ; American College of Cardiology's Interventional Council and the Society for Cardiovascular Angiography and Interventions. Catheterization Laboratory Considerations During the Coronavirus (COVID-19) Pandemic: From the ACC's Interventional Council and SCAI. J Am Coll Cardiol. 2020 May 12;75(18):2372-2375. doi: 10.1016/j.jacc.2020.03.021. Epub 2020 Mar 19. No abstract available.
• Garcia S, Albaghdadi MS, Meraj PM, Schmidt C, Garberich R, Jaffer FA, Dixon S, Rade JJ, Tannenbaum M, Chambers J, Huang PP, Henry TD. Reduction in ST-Segment Elevation Cardiac Catheterization Laboratory Activations in the United States During COVID-19 Pandemic. J Am Coll Cardiol. 2020 Jun 9;75(22):2871-2872. doi: 10.1016/j.jacc.2020.04.011. Epub 2020 Apr 10. No abstract available.
• Roffi M, Guagliumi G, Ibanez B. The Obstacle Course of Reperfusion for ST-Segment-Elevation Myocardial Infarction in the COVID-19 Pandemic. Circulation. 2020 Jun 16;141(24):1951-1953. doi: 10.1161/CIRCULATIONAHA.120.047523. Epub 2020 Apr 21. No abstract available.
• Rosenbaum L. The Untold Toll - The Pandemic's Effects on Patients without Covid-19. N Engl J Med. 2020 Jun 11;382(24):2368-2371. doi: 10.1056/NEJMms2009984. Epub 2020 Apr 17. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): February 28, 2022
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19 Outbreak; non COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-01017

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