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

July 1, 2023 updated by: Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Colombia
    • Meta
      • Villavicencio, Meta, Colombia, 50001
        • Recruiting
        • Hospital Departamental de Villavicencio
        • Contact:
        • Contact:
        • Principal Investigator:
          • Norton Perez Gutierrez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer
Death certificates of patients died by cancer or with cancer.
Other: Risk factor
No diagnostic or therapeutic intervention; the characteristics of subgroups will be analyzed by the cause of death certificated in the registry.
Other Names:
  • Cause of death
Cardiovascular
Death certificates of patients died by cardiovascular conditions or complications.
Other: Risk factor
No diagnostic or therapeutic intervention; the characteristics of subgroups will be analyzed by the cause of death certificated in the registry.
Other Names:
  • Cause of death
Tuberculosis
Death certificates of patients died by or with tuberculosis, including patients with HIV.
Other: Risk factor
No diagnostic or therapeutic intervention; the characteristics of subgroups will be analyzed by the cause of death certificated in the registry.
Other Names:
  • Cause of death
Infants
Death certificates of pediatric patients with more than a month of birth, and less than 18 years old.
Other: Risk factor
No diagnostic or therapeutic intervention; the characteristics of subgroups will be analyzed by the cause of death certificated in the registry.
Other Names:
  • Cause of death
Congenital malformations
Death certificates of patients died by congenital malformations, independently of age.
Other: Risk factor
No diagnostic or therapeutic intervention; the characteristics of subgroups will be analyzed by the cause of death certificated in the registry.
Other Names:
  • Cause of death
Maternal
Death certificates of patients died by obstetrical conditions during pregnancy or delivery.
Other: Risk factor
No diagnostic or therapeutic intervention; the characteristics of subgroups will be analyzed by the cause of death certificated in the registry.
Other Names:
  • Cause of death
Contagious
Death certificates of patients died by contagious/infectious diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of preventable deaths
Time Frame: 12 years
Deaths caused by diseases or conditions potentially preventable, according to the Holland criteria, or other authors.
12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Departamental de Villavicencio

Collaborators

Cooperative University of Colombia

Investigators

  • Principal Investigator: Norton Perez Gutierrez, MD, ICU director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

February 12, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRIVI_2023_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) is collected from an institutional registry of deceased people retrospectively. Even when it does not contain the personal information of participants, the database will not be shared in a repository. The trial final report will be uploaded in Mendeley Data and published in an indexed journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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