Impact of COVID-19 Outbreak on Non-COVID-19 Patients

COVID-19 Clinical Trial

— NoCOVImpact  

Official title:

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04537559
• Other study ID #: 2020-01017
• Status: Enrolling by invitation
• Start date: March 1, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240000
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva	Canton De Genève

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	La Tour Hospital

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-hospital mortality	death during hospitalization of each patient	Assessed at the discharge date, up to 3 months after admission
Primary	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	Pathologies leading to hospitalization	Primary and secondary diagnosis during hospitalization (CIM10 codes)	At the discharge date of hospitalization, up to 3 months after admission
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	specific gravity outcomes for patients with cardiac Failure or lung disease	FIO2 (% O2 prescribed): Fraction of inspired oxygen	At the acute care admission
Secondary	Leukocytes serum level	Giga / litre	At the acute care admission
Secondary	Polynuclear neutrophils serum level	Giga / litre	At the acute care admission
Secondary	Lymphocytes serum level	Giga / litre	At the acute care admission
Secondary	Hemoglobin serum level	gram/litre	At the acute care admission
Secondary	Thrombocytes serum level	Giga / litre	At the acute care admission
Secondary	Quick serum level	in %	At the acute care admission
Secondary	INR (International Normalized Ratio)	No unit	At the acute care admission
Secondary	fibrinogen serum level	gram/litre	At the acute care admission
Secondary	PTT serum level (partial Thromboplastin time)	in second	At the acute care admission
Secondary	D-Dimers serum level	ng / ml	At the acute care admission
Secondary	glucose serum level	mmol / litre	At the acute care admission
Secondary	glycated hemoglobin serum level (HbA1C)	in %	At the acute care admission
Secondary	C-reactive protein serum level (CRP)	mg / litre	At the acute care admission
Secondary	sodium serum level	mmol / l	At the acute care admission
Secondary	potassium serum level	mmol / l	At the acute care admission
Secondary	chlorides serum level	mmol / l	At the acute care admission
Secondary	calculated osmolality serum level	mOsm / kg	At the acute care admission
Secondary	Phosphates serum level	mmol / l	At the acute care admission
Secondary	corrected calcium serum level	mmol / l	At the acute care admission
Secondary	urea serum level	mmol / l	At the acute care admission
Secondary	creatinine serum level	µmol / l	At the acute care admission
Secondary	eGFR (CKD-EPI) serum level	ml / min / 1.73m2	At the acute care admission
Secondary	albumin serum level	g / l	At the acute care admission
Secondary	prealbumin serum level	mg / l	At the acute care admission
Secondary	cyanocobalamin serum level	pmol / l	At the acute care admission
Secondary	folate serum level	nmol / l	At the acute care admission
Secondary	25-hydroxy vitamin D (D2 + D3) serum level	nmol / l	At the acute care admission
Secondary	proBNP (Brain Natriuretic Peptid) serum level	ng / l	At the acute care admission
Secondary	Ultra sensitive Troponin T serum level	ng / l	At the acute care admission
Secondary	ASAT (aspartate transaminase) serum level	U / l	At the acute care admission
Secondary	ALAT (alanine aminotransferase) serum level	U / l	At the acute care admission
Secondary	Alkaline phosphatases serum level	U / l	At the acute care admission
Secondary	Gamma glutamyl transpeptidase. serum level	U / l	At the acute care admission
Secondary	Total bilirubin serum level	µmol / l	At the acute care admission
Secondary	ferritin serum level	µg / l	At the acute care admission
Secondary	TSH serum level	mU / l	At the acute care admission
Secondary	Arterial pH	No unit	At the acute care admission
Secondary	Arterial pCO2 (carbon dioxide partial pressure)	kPa	At the acute care admission
Secondary	Arterial pO2 (oxygen partial pressure)	kPa	At the acute care admission
Secondary	Arterial lactate	mmol / l	At the acute care admission
Secondary	Arterial HCO3 (bicarbonate)	mmol / l	At the acute care admission
Secondary	protein serum level	g / l	At the acute care admission
Secondary	Arterial pressure	Arterial pression (min-max), in mmHg	At the acute care admission
Secondary	cardiac rates	Bat/mn	At the acute care admission
Secondary	respiratory rates	/mn	At the acute care admission
Secondary	temperature	Celsius degrees	At the acute care admission
Secondary	oxygen saturation	Percutaneous oxygen saturation (in %)	At the acute care admission
Secondary	peak flow	L/mn	At the acute care admission
Secondary	specific scales : VAS of pain	Visual analog Pain scale (min-max : 1 to 10 [worse outcome])	At the acute care admission
Secondary	specific scales : FIM	Functional Independence Measure (min-max : 18 [worse outcome]) to 126)	At the acute care admission
Secondary	specific scales : SOFA score	Sequential Organ Failure Assessment Score (min-max : 0 to 24 [worse outcome])	At the acute care admission
Secondary	specific scales : MNA	Mini Nutritional Assessment (min-max : 0 [worse outcome] to 14)	At the acute care admission
Secondary	specific scales : NRS	Nutrition Risk Screening (min-max : 0 to 12 [worse outcome])	At the acute care admission
Secondary	serum or urine positive bacteriologic sample	number of positive hemoculture or urinary cultures	At the acute care admission or during hospitalization
Secondary	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