NCT05739305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

February 12, 2023

Last Update Submit

December 9, 2024

Conditions

Keywords

Death CertificateHospital MortalityEpidemiologyPublic HealthCancerGeriatricsNeoplasmsColombian OrinoquiaColombia

Outcome Measures

Primary Outcomes (1)

  • Number of preventable deaths

    Deaths caused by diseases or conditions potentially preventable, according to the Holland criteria, or other authors.

    12 years

Study Arms (7)

Cancer

Death certificates of patients died by cancer or with cancer.

Other: Risk factor

Cardiovascular

Death certificates of patients died by cardiovascular conditions or complications.

Other: Risk factor

Tuberculosis

Death certificates of patients died by or with tuberculosis, including patients with HIV.

Other: Risk factor

Infants

Death certificates of pediatric patients with more than a month of birth, and less than 18 years old.

Other: Risk factor

Congenital malformations

Death certificates of patients died by congenital malformations, independently of age.

Other: Risk factor

Maternal

Death certificates of patients died by obstetrical conditions during pregnancy or delivery.

Other: Risk factor

Contagious

Death certificates of patients died by contagious/infectious diseases.

Interventions

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

Also known as: Cause of death
CancerCardiovascularCongenital malformationsInfantsMaternalTuberculosis

Eligibility Criteria

AgeUp to 120 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, 50001, Colombia

Location

Related Publications (10)

  • 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.

  • 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.

  • 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.0268566. eCollection 2022.

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

NeoplasmsChronic DiseaseNoncommunicable Diseases

Interventions

Risk FactorsCause of Death

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public HealthMortalityVital StatisticsData CollectionDemographyPopulation CharacteristicsEpidemiologic Measurements

Study Officials

  • Norton Perez Gutierrez, MD

    ICU director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ICU Director

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 22, 2023

Study Start

July 1, 2023

Primary Completion

December 31, 2023

Study Completion

May 30, 2024

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

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.

Locations