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NCT05897229 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05897229
Other study ID # 31385420.6.1001.0068
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date October 1, 2026

Study information
Verified date June 2023
Source University of Sao Paulo General Hospital
Contact Maria DC Otero Rodriguez, BSc
Phone + 55 11 2661-2407
Email maria.rodriguez@hc.fm.usp.br
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date October 1, 2026
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo General Hospital

References & 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.

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. — View Citation

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. — View Citation

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. — View 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.

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. — View 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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Sociodemographic profile age and sex to identify and analyze the profile of the patients included in the study. Hospitalizations between April 8th to July 31th, 2020
Secondary Clinical profile 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
Secondary Length of stay and inpatient settings 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
Secondary Time to call Palliative Care group 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
Secondary Life-sustaining procedures 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
Secondary Inpatient daily rates rates for Palliative Care unit (PC), ICU and PC & ICU to analyze the costs. Hospitalizations between April 8th to July 31th, 2020
Secondary Outcome of hospitalization 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
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