Death Certificate Analysis at Colombian Orinoquia: A Retrospective Observational Trial.

Cancer Clinical Trial

Official title:

Death Certificate Analysis and Mortality at a Hospital From Colombian Orinoquia: A Retrospective Observational Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739305
• Other study ID #: GRIVI_2023_01
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: Hospital Departamental de Villavicencio
• Contact: Norton Perez, MD
• Phone: 3112517471
• Email: norton.perez[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

By hospital mortality, the health of a population is identified. Death certificates are a valuable tool in establishing causes of death. The objective will be to analyze the main causes of death in hospitalized patients by population groups of interest. A retrospective observational study will be carried out, by analyzing the death databases of the Hospital Departamental of Villavicencio from January 2012 to May 2022. The records will be exported to Excel for review and debugging. Demographic variables and causes of death will be analyzed. The categorical variables will be described in frequency and proportion; the quantitative ones will be defined in their central distribution and dispersion. For comparison, the Chi-square and Mann-Whitney test will be performed according to the characteristics of the outcome studied. It is expected to identify the main causes of death in the groups of interest (adults, maternal, infants, fetal and non-fetal, congenital malformations) and their characteristics.

Description:

Hospital mortality is a measure of the effectiveness of interventions in health, and its systematic evaluation is convenient, as an indicator of clinical management. It is considered that in internal medicine services, it can be between 6-21%, which depends on its complexity. and the population of influence. The identification of hospital causes of death (COD) makes it possible to recognize the prevailing public health problems in the population. This information is relevant for decision-making, planning, and directing public and institutional policy. Hospital mortality is an important source of these data, in a region where most deaths occur at hospital settings. The proportion of deaths in hospitals is growing internationally and in Villavicencio, this could be the case in most cases. There are few alternatives for palliative care and end-of-life care in low and middle-income countries. Few studies analyze information from hospital institutions. Access to death indices is free in countries such as Spain, in order to allow studies on the health of the population. Even so, there is concern about the quality of the records, from health organizations, although the uncertainty that involves establishing the COD does not necessarily conflict with the precision of metrology, according to more pragmatic thoughts. The death certificate (CD) is the main source of data on mortality. CDs are the legal record of the causes of death and are usually made by health personnel, mainly doctors. Such information is essential to establish the priorities in health policies, of each individual institution, and in the general population. They collectively indicate the state of health of a nation. Uncertainty about the cause of death can be a significant challenge in scenarios such as unexpected death or after a prolonged period without medical attention. Errors in completing the information on CDs are recognized as a universal problem, which can lead to confusion in the prevalence of causes of death (COD). The use of ill-defined codes and conditions (CCMD) as COD is frequent at a universal level. Some have considered that the doctor should be socialized with the vital status and COD of their patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Gender: All
• Age group: N/A to 120 Years

Eligibility

Inclusion Criteria:

• Deceased people during hospitalization.
• Out-of-hospital deceased people (home) and certified by the institution

Exclusion Criteria:

• Registers of people deceased by an external (violent) cause.
• Registers of people that required certification by the Coroner's office.

Related Conditions & MeSH terms

• Cancer
• Chronic Disease
• Hospital Mortality
• Noncommunicable Diseases
• Public Health

Intervention

Other:
• Risk factor
No diagnostic or therapeutic intervention; the characteristics of subgroups will be analyzed by the cause of death certificated in the registry.

Locations

Country	Name	City	State
Colombia	Hospital Departamental de Villavicencio	Villavicencio	Meta

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Departamental de Villavicencio	Cooperative University of Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (10)

Armstrong D. The COVID-19 pandemic and cause of death. Sociol Health Illn. 2021 Aug;43(7):1614-1626. doi: 10.1111/1467-9566.13347. Epub 2021 Jul 13. — View Citation

Carvajal Y, Kottow M. [The metrology of uncertainty: a study of vital statistics from Chile and Brazil]. Cad Saude Publica. 2012 Nov;28(11):2063-75. doi: 10.1590/s0102-311x2012001100006. Spanish. — View Citation

Cendales R, Pardo C. [Colombian death certificate quality, 2002-2006]. Rev Salud Publica (Bogota). 2011 Apr;13(2):229-38. doi: 10.1590/s0124-00642011000200005. Spanish. — View Citation

Cirera L, Segura A. [Updated medical death documents: Medical Death Certificate and the Birth Statistics Bulletin]. Aten Primaria. 2010 Aug;42(8):431-7. doi: 10.1016/j.aprim.2009.09.029. Epub 2010 May 27. Spanish. — View Citation

Ferorelli D, Donno F, De Giorgio G, Zotti F, Dell'Erba A. Study of determinants in deaths occurring in an Italian teaching hospital during a year. Clin Ter. 2020 May-Jun;171(3):e245-e252. doi: 10.7417/CT.2020.2222. — View Citation

Morgan A, Andrew T, Guerra SMA, Luna V, Davies L, Rees JR. Provider reported challenges with completing death certificates: A focus group study demonstrating potential sources of error. PLoS One. 2022 May 20;17(5):e0268566. doi: 10.1371/journal.pone.02685 — View Citation

Murphy SL, Xu J, Kochanek KD, Arias E. Mortality in the United States, 2017. NCHS Data Brief. 2018 Nov;(328):1-8. — View Citation

Ng TC, Lo WC, Ku CC, Lu TH, Lin HH. Improving the Use of Mortality Data in Public Health: A Comparison of Garbage Code Redistribution Models. Am J Public Health. 2020 Feb;110(2):222-229. doi: 10.2105/AJPH.2019.305439. Epub 2019 Dec 19. — View Citation

Sainz-Otero AM, Marin-Paz AJ, Almenara-Barrios J. The Classification of Causes of Historical Mortality (CCHM): A proposal of the study of death records. PLoS One. 2020 Apr 14;15(4):e0231311. doi: 10.1371/journal.pone.0231311. eCollection 2020. — View Citation

Viana Alonso A, Delgado Cirerol V, de la Morena Fernandez J. [Validity of the final diagnosis in the discharge reports of deceased patients in a teaching department of internal medicine]. Rev Clin Esp. 1992 Oct;191(6):323-4. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of preventable deaths	Deaths caused by diseases or conditions potentially preventable, according to the Holland criteria, or other authors.	12 years

External Links

•   Mortality in patients hospitalized in the internal medicine service of a university hospital. An article from a local journal with a study about a university hospital mortality.
•   Tendencias en la mortalidad de médicos generales y especialistas en Cali, Colombia. Unique article exploring the cause of death of medical doctors in Cali, Colombia.