Palliative Care in Patients With COVID-19: Analysis of Costs of Hospitalization in Wards and Intensive Care Units

June 12, 2023 updated by: Ricardo Tavares de Carvalho, University of Sao Paulo General Hospital
The confrontation of COVID-19 foreshadowed a serious crisis of scarce health resources worldwide. To assist in this confrontation, the Palliative Care Scientific Technical Core of the Clinical Hospital, School of Medicine, Sao Paulo University (USP) elaborated a Triage Protocol for Palliative Care (PALI-COVID Tool) and it was possible to categorize the patients in three groups, according to the risk of death and needs of Palliative Care (PC), through the clinical evaluation of the patient that also directed them to the hospitalization resource according to their need (ward x ICU).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients grouped as with higher risk of death and PC needs (green group) by PALI-COVID Tool were those with a profile of end-of-life, signs of clinical deterioration and risk of death on admission and thus indicated for admission to the COVID-19 Palliative Care Inpatient Unit, however some were admitted to the ICU. Objective: to analyze the direct costs of hospitalization of COVID-19 Palliative Care patients in Palliative Care Inpatient Unit and ICU screened as green group by the COVID-19 Screening Protocol developed in the institution. Methods: observational, cross-sectional and retrospective study of the service database of patients over 18 years of age screened as the green group (PALI-COVID). The variables to be investigated are related to sociodemographic and clinical data, length of stay and hospitalization scenarios, time to call for PC, outcome and costs.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A screening protocol was created by us for stratification of patients admitted due to risk of death and PC needs - the PALICOVID. Patients classified by PALICOVID in the most severe group (terminal illness and clinical criteria of high risk of death prior to COVID-19) were referred to the PC Inpatient Unit. These patients were admitted, at the physician's discretion, in the PC unit or ICU. The mortality of patients in both groups was similar. Thus, the characterization of the sample according to demographic, clinical data, and comparative analysis of direct and indirect costs during hospitalization between the subgroups (PC, ICU and PC & ICU ) will be performed.

Description

Inclusion Criteria:

  • inpatients with severe forms of COVID-19 between April 08 and July 31, 2020
  • positive reverse-transcriptase polymerase chain reaction (RT-PCR).
  • patients with terminal illness and high clinical risk of death before COVID-19.
  • those admitted to an ICU or palliative care unit.

Exclusion Criteria:

  • absence of hospitalization cost data in the institution's electronic records

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
PC - end-stage disease criteria and high risk of death from the disease prior to COVID-19

Patients with severe forms of COVID-19 (RT-PCR+) admitted to a high-complexity hospital.

Of these, patients with end-stage disease criteria and high risk of death from the disease prior to COVID-19 were admitted, at clinical criteria, to palliative care unit.

If there are patients who received both types of treatment, this group will also be analyzed.
Other: Analysis of costs with patient care during hospitalization
Analysis of direct costs with supplies, medications, diets, laboratory tests and imaging exams, and invasive procedures such as mechanical ventilation, dialysis, and the use of vasoactive drugs.-analysis of costs referring to working hours of physicians, nurses and physical therapists in each unit normalized for the same number of beds.- cost minimization and consequential cost analysis.
ICU - end-stage disease criteria and high risk of death from the disease prior to COVID-19

Patients with severe forms of COVID-19 (RT-PCR+) admitted to a high-complexity hospital.

Of these, patients with end-stage disease criteria and high risk of death from the disease prior to COVID-19 were admitted, at clinical criteria, to the ICU.

If there are patients who received both types of treatment, this group will also be analyzed.
Other: Analysis of costs with patient care during hospitalization
Analysis of direct costs with supplies, medications, diets, laboratory tests and imaging exams, and invasive procedures such as mechanical ventilation, dialysis, and the use of vasoactive drugs.-analysis of costs referring to working hours of physicians, nurses and physical therapists in each unit normalized for the same number of beds.- cost minimization and consequential cost analysis.
PC & ICU - end-stage disease criteria and high risk of death from the disease prior to COVID-19

Patients with severe forms of COVID-19 (RT-PCR+) admitted to a high-complexity hospital.

Of these, patients with end-stage disease criteria and high risk of death from the disease prior to COVID-19 were admitted, at clinical criteria, to the ICU and palliative care unit.

If there are patients who received both types of treatment, this group will also be analyzed.
Other: Analysis of costs with patient care during hospitalization
Analysis of direct costs with supplies, medications, diets, laboratory tests and imaging exams, and invasive procedures such as mechanical ventilation, dialysis, and the use of vasoactive drugs.-analysis of costs referring to working hours of physicians, nurses and physical therapists in each unit normalized for the same number of beds.- cost minimization and consequential cost analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct costs (supplies)
Time Frame: Hospitalizations between April 8th to July 31th, 2020
costs related to supplies, medications, diets, laboratory tests, imaging exams, and invasive procedures (such as mechanical ventilation, dialysis, and the use of vasoactive drugs). The costs will be calculate for the three groups and compared between them.
Hospitalizations between April 8th to July 31th, 2020
Direct costs (working hours)
Time Frame: Hospitalizations between April 8th to July 31th, 2020
costs referring to working hours of health professionals (physicians, nurses and physical therapists) in each unit normalized for the same number of beds. The costs will be calculate for the three groups and compared between them.
Hospitalizations between April 8th to July 31th, 2020
Cost minimization, and consequential cost analysis
Time Frame: Hospitalizations between April 8th to July 31th, 2020
all the costs will be compared between them to do a cost-effectiveness analysis as the death rate will be probabily similar in the three groups.
Hospitalizations between April 8th to July 31th, 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic profile
Time Frame: Hospitalizations between April 8th to July 31th, 2020
age and sex to identify and analyze the profile of the patients included in the study.
Hospitalizations between April 8th to July 31th, 2020
Clinical profile
Time Frame: Hospitalizations between April 8th to July 31th, 2020
diagnosis, underlying disease, comorbidities to identify and analyze the profile of the patients included in the study.
Hospitalizations between April 8th to July 31th, 2020
Length of stay and inpatient settings
Time Frame: Hospitalizations between April 8th to July 31th, 2020
length of stay at Palliative Care unit (PC), ICU and PC & ICU to identify and analyze the profile of the patients included in the study and analyze the costs.
Hospitalizations between April 8th to July 31th, 2020
Time to call Palliative Care group
Time Frame: Hospitalizations between April 8th to July 31th, 2020
admission to the institution, date of call of PC, first assessment of PC, indication of transfer to a COVID-19 PC unit, and date of transfer to PC unit to identify and analyze the time it took for staff to recognize the need for CP for the patients that has repercussions on the cost of hospitalization.
Hospitalizations between April 8th to July 31th, 2020
Life-sustaining procedures
Time Frame: Hospitalizations between April 8th to July 31th, 2020
such as mechanical ventilation, dialysis, and the use of vasoactive drugs to identify and analyze the use of life-sustaining procedures in the study population and analyze the costs.
Hospitalizations between April 8th to July 31th, 2020
Inpatient daily rates
Time Frame: Hospitalizations between April 8th to July 31th, 2020
rates for Palliative Care unit (PC), ICU and PC & ICU to analyze the costs.
Hospitalizations between April 8th to July 31th, 2020
Outcome of hospitalization
Time Frame: Hospitalizations between April 8th to July 31th, 2020
hospital discharge, transference, and death to identify and analyze the profile of the patients included in the study and to make a cost-effectiveness analysis with the all costs that will be analyzed.
Hospitalizations between April 8th to July 31th, 2020

Collaborators and Investigators

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

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Ricardo T de Carvalho, MD, PhD, University of Sao Paulo General Hospital

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.

General Publications

Helpful Links

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 (Estimated)

October 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31385420.6.1001.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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