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

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05897229
Collaborator
(none)
200
36

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Analysis of costs with patient care during hospitalization

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Palliative Care in Patients With COVID-19: Analysis of Costs of Hospitalization in Wards and Intensive Care Units
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Oct 1, 2026

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Direct costs (supplies) [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.

  2. Direct costs (working hours) [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.

  3. Cost minimization, and consequential cost analysis [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.

Secondary Outcome Measures

  1. Sociodemographic profile [Hospitalizations between April 8th to July 31th, 2020]

    age and sex to identify and analyze the profile of the patients included in the study.

  2. Clinical profile [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.

  3. Length of stay and inpatient settings [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.

  4. Time to call Palliative Care group [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.

  5. Life-sustaining procedures [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.

  6. Inpatient daily rates [Hospitalizations between April 8th to July 31th, 2020]

    rates for Palliative Care unit (PC), ICU and PC & ICU to analyze the costs.

  7. Outcome of hospitalization [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Sao Paulo General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Ricardo Tavares de Carvalho, Collaborator Professor, Palliative Care Departament Coordinator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT05897229
Other Study ID Numbers:
  • 31385420.6.1001.0068
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ricardo Tavares de Carvalho, Collaborator Professor, Palliative Care Departament Coordinator, University of Sao Paulo General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023