Hospital MortalityNCT05739305
Death Certificate Analysis at Colombian Orinoquia: A Retrospective Observational Trial.
An observational study of Hospital Mortality and Cancer, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Hospital Mortality, Cancer, Chronic Disease
- What is being tested?
- Risk factor
- How many people
- 10,000 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jul 2023to 30 May 2024
- 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 Up to 120 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Deceased people during hospitalization.
- Out-of-hospital deceased people (home) and certified by the institution
Who cannot join
- Registers of people deceased by an external (violent) cause.
- Registers of people that required certification by the Coroner's office.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Departamental de Villavicencio
Villavicencio, Meta Department, 50001
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Hospital Mortality, Cancer, Chronic Disease, Non Communicable Chronic Diseases, Public Health
- Being tested
- Risk factor
- Keywords
- Death Certificate, Hospital Mortality, Epidemiology, Public Health, Cancer, Geriatrics, Neoplasms, Colombian Orinoquia, Colombia
- Medical subject headings
- Neoplasms, Chronic Disease, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk factorOther
Also called Cause of death
No diagnostic or therapeutic intervention; the characteristics of subgroups will be analyzed by the cause of death certificated in the registry.
| Study group | Role | What they receive |
|---|---|---|
| Cancer | Death certificates of patients died by cancer or with cancer. Receives: Other: Risk factor | |
| Cardiovascular | Death certificates of patients died by cardiovascular conditions or complications. Receives: Other: Risk factor | |
| Tuberculosis | Death certificates of patients died by or with tuberculosis, including patients with HIV. Receives: Other: Risk factor | |
| Infants | Death certificates of pediatric patients with more than a month of birth, and less than 18 years old. Receives: Other: Risk factor | |
| Congenital malformations | Death certificates of patients died by congenital malformations, independently of age. Receives: Other: Risk factor | |
| Maternal | Death certificates of patients died by obstetrical conditions during pregnancy or delivery. Receives: Other: Risk factor | |
| Contagious | Death certificates of patients died by contagious/infectious diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of preventable deaths
Deaths caused by diseases or conditions potentially preventable, according to the Holland criteria, or other authors.
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hospital MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Departamental de Villavicencio
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperative University of Colombia
- Responsible party
- Principal investigator, Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio
- Investigators
- Norton Perez Gutierrez, MD, Principal investigator, ICU director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739305
- Sponsor's protocol ID
- GRIVI_2023_01
- Status last verified
- Dec 2024
- First submitted
- 12 Feb 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 23147948Ferorelli 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.
PubMed 32323714Morgan 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.
PubMed 35594279Ng 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.
PubMed 31855478Cirera 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.
PubMed 20537431Cendales 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.
PubMed 22030881Murphy SL, Xu J, Kochanek KD, Arias E. Mortality in the United States, 2017. NCHS Data Brief. 2018 Nov;(328):1-8.
PubMed 30500322Viana 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.
PubMed 1470725Armstrong 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.
PubMed 34255866Sainz-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.
PubMed 32287285
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Death Certificate Analysis and Mortality at a Hospital From Colombian Orinoquia: A Retrospective Observational Trial.
- ClinicalTrials.gov ID
- NCT05739305
- Acronym / sponsor ID
- GRIVI_2023_01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Hospital Departamental de VillavicencioUniversity, hospital or other
- Collaborators
- Cooperative University of Colombia
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cancer | – | Other: Risk factorDeath certificates of patients died by cancer or with cancer. |
| Cardiovascular | – | Other: Risk factorDeath certificates of patients died by cardiovascular conditions or complications. |
| Tuberculosis | – | Other: Risk factorDeath certificates of patients died by or with tuberculosis, including patients with HIV. |
| Infants | – | Other: Risk factorDeath certificates of pediatric patients with more than a month of birth, and less than 18 years old. |
| Congenital malformations | – | Other: Risk factorDeath certificates of patients died by congenital malformations, independently of age. |
| Maternal | – | Other: Risk factorDeath certificates of patients died by obstetrical conditions during pregnancy or delivery. |
| Contagious | – | –Death certificates of patients died by contagious/infectious diseases. |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Deceased people during hospitalization.
- Out-of-hospital deceased people (home) and certified by the institution
Key exclusion criteria (2 listed)
- Registers of people deceased by an external (violent) cause.
- Registers of people that required certification by the Coroner's office.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk factorAlso: Cause of deathNo diagnostic or therapeutic intervention; the characteristics of subgroups will be analyzed by the cause of death certificated in the registry. | Other | Cancer, Cardiovascular, Congenital malformations, Infants, Maternal, Tuberculosis |
Primary outcome
Number of preventable deaths
Time frame: 12 years
Deaths caused by diseases or conditions potentially preventable, according to the Holland criteria, or other authors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Results publication: PubMed 23147948Carvajal 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.
- Results publication: PubMed 32323714Ferorelli 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.
- Results publication: PubMed 35594279Morgan 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.
- Results publication: PubMed 31855478Ng 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.
- Results publication: PubMed 20537431Cirera 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.
- Results publication: PubMed 22030881Cendales 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.
- Results publication: PubMed 30500322Murphy SL, Xu J, Kochanek KD, Arias E. Mortality in the United States, 2017. NCHS Data Brief. 2018 Nov;(328):1-8.
- Results publication: PubMed 1470725Viana 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.
- Results publication: PubMed 34255866Armstrong 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.
- Results publication: PubMed 32287285Sainz-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.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norton Perez Gutierrez, MD principal investigator
ICU director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital Mortality and Cancer, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of preventable deaths (time frame: 12 years). 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 NCT05739305, which also lists 10 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 12 Dec 2024.