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

NCT05897229 | Not Yet Recruiting

• 1 other identifier: 31385420.6.1001.0068
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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).

Conditions

COVID-19; Palliative Care

Keywords

Palliative care; COVID-19; Cost allocation; Cost control; Organization and Administration

Outcome Measures

Primary Outcomes (3)

• Direct costs (supplies)

  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)

  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

  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 Outcomes (7)

• Sociodemographic profile

  Hospitalizations between April 8th to July 31th, 2020

• Clinical profile

  Hospitalizations between April 8th to July 31th, 2020

• Length of stay and inpatient settings

  Hospitalizations between April 8th to July 31th, 2020

• Time to call Palliative Care group

  Hospitalizations between April 8th to July 31th, 2020

• Life-sustaining procedures

  Hospitalizations between April 8th to July 31th, 2020

Study Arms (3)

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

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

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

Interventions

Analysis of costs with patient care during hospitalization OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (8)

• Anagusko SS, Rosa IB, Angelo MFF. Fundamentos dos Cuidados Paliativos aplicados à pandemia. In: Daniel Battacini Dei Santi, Luciana Suely Barros Cavalcante, Ednalda Maria Franck,Ricardo Tavares de Carvalho. (Org.). Cuidados Paliativos na Prática Clínica em Tempos de COVID-19. 1ed.Rio de Janeiro: Atheneu, 2021, v. 1, p. 5-15.

  BACKGROUND

• Carvalho RT, Crispim DH, Franck EM, Dei Santi DB, Anagusko SS, Fukuda MV, Cavalcante LSB, Jales SMDCP, Queiroz MEG, Bonfa ESDO. Palliative care in the COVID-19 pandemic: Strategy of HCFMUSP. Clinics (Sao Paulo). 2022 Jan-Dec;77:100050. doi: 10.1016/j.clinsp.2022.100050. Epub 2022 May 17. No abstract available.

  PMID: 35662009 BACKGROUND

• Downar J, Seccareccia D; Associated Medical Services Inc. Educational Fellows in Care at the End of Life. Palliating a pandemic: "all patients must be cared for". J Pain Symptom Manage. 2010 Feb;39(2):291-5. doi: 10.1016/j.jpainsymman.2009.11.241.

  PMID: 20152591 BACKGROUND

• Fadul N, Elsayem AF, Bruera E. Integration of palliative care into COVID-19 pandemic planning. BMJ Support Palliat Care. 2021 Mar;11(1):40-44. doi: 10.1136/bmjspcare-2020-002364. Epub 2020 Jun 11.

  PMID: 32527790 BACKGROUND

• Franck EM, Jales SMCP, Dei Santi DB, Cavalcante LSB, Silva MLF. A equipe multiprofissional na pandemia: novas formas de atuação, antigos desafios. In: Daniel Battacini Dei Santi, Luciana Suely Barros Cavalcante, Ednalda Maria Franck, Ricardo Tavares de Carvalho. (Org.). Cuidados Paliativos na Prática Clínica em Tempos de COVID-19. 1ed.Rio de Janeiro: Atheneu, 2021, v. 1, p. 31-44.

  BACKGROUND

• May P, Normand C, Cassel JB, Del Fabbro E, Fine RL, Menz R, Morrison CA, Penrod JD, Robinson C, Morrison RS. Economics of Palliative Care for Hospitalized Adults With Serious Illness: A Meta-analysis. JAMA Intern Med. 2018 Jun 1;178(6):820-829. doi: 10.1001/jamainternmed.2018.0750.

  PMID: 29710177 BACKGROUND

• Medical guidelines for determining prognosis in selected non-cancer diseases. The National Hospice Organization. Hosp J. 1996;11(2):47-63. doi: 10.1080/0742-969x.1996.11882820. No abstract available.

  PMID: 8949013 BACKGROUND

• Sheridan PE, LeBrett WG, Triplett DP, Roeland EJ, Bruggeman AR, Yeung HN, Murphy JD. Cost Savings Associated With Palliative Care Among Older Adults With Advanced Cancer. Am J Hosp Palliat Care. 2021 Oct;38(10):1250-1257. doi: 10.1177/1049909120986800. Epub 2021 Jan 11.

  PMID: 33423523 BACKGROUND

Related Links

• Brazil.Law No. 13.709 General Law for the Protection of Personal Data (LGPD). 2018.
• Brazil. Law No. 13,979 provides for the measures for dealing with the public health emergency of international importance resulting from the coronavirus responsible for the public health outbreak of international importance resulting from the coronavirus
• World Health Organization(WHO).Building integrated Palliative Care programs and services.2017
• Oxford University.Our world in data: coronavirus (COVID-19) data. 2020
• WHO.Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises: a WHO guide. 2022

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ricardo T de Carvalho, MD, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria DC Otero Rodriguez, BSc

CONTACT

+ 55 11 2661-2407; maria.rodriguez@hc.fm.usp.br

Ednalda M Franck, RN, MSc

CONTACT

+ 55 11 99814-6580; ednalda.franck@hc.fm.usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborator Professor, Palliative Care Departament Coordinator

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 9, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 15, 2023

Record last verified: 2023-06