Clinical trial NCT05739305: Death Certificate Analysis at Colombian Orinoquia: A Retrospective Observational Trial.
Official title: Death Certificate Analysis and Mortality at a Hospital From Colombian Orinoquia: A Retrospective Observational Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospital Mortality
Cancer
Chronic Disease
Non Communicable Chronic Diseases
Public Health
Keywords: Death Certificate
Hospital Mortality
Epidemiology
Public Health
Cancer
Geriatrics
Neoplasms
Colombian Orinoquia
Colombia
Lead sponsor: Hospital Departamental de Villavicencio
Sponsor class: OTHER
Collaborators: name: Cooperative University of Colombia
First posted: 2023-02-22
Enrollment: 10000
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population included in the study are those included in the institutional registry of death certification after they died in the hospital or somewhere else, but had to be certified by a doctor from it for any reason.

People who died by an external cause included in chapters XIX and XX of 10-ICD were excluded from the study.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of preventable deaths
timeFrame: 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: Villavicencio
country: Colombia
facility: Hospital Departamental de Villavicencio
state: Meta
Study officials:
affiliation: ICU director
name: Norton Perez Gutierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.