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COVID-19NCT05897229

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

An observational study of COVID-19 and Palliative Care, run by University of Sao Paulo General Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Palliative Care
What is being tested?
Analysis of costs with patient care during hospitalization
How many people
200 participants
Where
No sites listed yet
Study dates
1 Oct 2023to 1 Oct 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

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

About this study

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).

Read the 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.

Being tested
Analysis of costs with patient care during hospitalization
Keywords
Palliative care, COVID-19, Cost allocation, Cost control, Organization and Administration
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Analysis of costs with patient care during hospitalizationOther

    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.

Study groups in NCT05897229
Study groupRoleWhat they receive
PC - end-stage disease criteria and high risk of death from the disease prior to COVID-19Patients 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.
Receives: 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-19Patients 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.
Receives: 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-19Patients 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.
Receives: Other: Analysis of costs with patient care during hospitalization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Hospitalizations between April 8th to July 31th, 2020

  2. 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.

    Measured: Hospitalizations between April 8th to July 31th, 2020

  3. 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.

    Measured: Hospitalizations between April 8th to July 31th, 2020

Secondary outcomes (7)
  1. Sociodemographic profile

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

    Measured: Hospitalizations between April 8th to July 31th, 2020

  2. Clinical profile

    diagnosis, underlying disease, comorbidities to identify and analyze the profile of the patients included in the study.

    Measured: Hospitalizations between April 8th to July 31th, 2020

  3. 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.

    Measured: Hospitalizations between April 8th to July 31th, 2020

  4. 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.

    Measured: Hospitalizations between April 8th to July 31th, 2020

  5. 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.

    Measured: Hospitalizations between April 8th to July 31th, 2020

  6. Inpatient daily rates

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

    Measured: Hospitalizations between April 8th to July 31th, 2020

  7. 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.

    Measured: Hospitalizations between April 8th to July 31th, 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start1 Oct 2023 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05897229
Sponsor's protocol ID
31385420.6.1001.0068
Status last verified
Jun 2023
First submitted
7 Jun 2023
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35662009
  • 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.

    PubMed 20152591
  • 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.

    PubMed 32527790
  • 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.

    PubMed 29710177
  • 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.

    PubMed 8949013
  • 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.

    PubMed 33423523

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Palliative Care, run by University of Sao Paulo General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria DC Otero Rodriguez, BSc (+ 55 11 2661-2407, maria.rodriguez@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Direct costs (supplies) (time frame: Hospitalizations between April 8th to July 31th, 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05897229, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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