Clinical trial NCT05897229: Palliative Care in Patients With COVID-19: Analysis of Costs of Hospitalization in Wards and Intensive Care Units
Official title: Palliative Care in Patients With COVID-19: Analysis of Costs of Hospitalization in Wards and Intensive Care Units
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COVID-19
Palliative Care
Keywords: Palliative care
COVID-19
Cost allocation
Cost control
Organization and Administration
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Direct costs (supplies)
timeFrame: Hospitalizations between April 8th to July 31th, 2020
measure: Direct costs (working hours)
timeFrame: Hospitalizations between April 8th to July 31th, 2020
measure: Cost minimization, and consequential cost analysis
timeFrame: Hospitalizations between April 8th to July 31th, 2020
Secondary outcomes:
measure: Sociodemographic profile
timeFrame: Hospitalizations between April 8th to July 31th, 2020
measure: Clinical profile
timeFrame: Hospitalizations between April 8th to July 31th, 2020
measure: Length of stay and inpatient settings
timeFrame: Hospitalizations between April 8th to July 31th, 2020
measure: Time to call Palliative Care group
timeFrame: Hospitalizations between April 8th to July 31th, 2020
measure: Life-sustaining procedures
timeFrame: Hospitalizations between April 8th to July 31th, 2020
measure: Inpatient daily rates
timeFrame: Hospitalizations between April 8th to July 31th, 2020
measure: Outcome of hospitalization
timeFrame: Hospitalizations between April 8th to July 31th, 2020
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Ricardo T de Carvalho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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