Surgical ConditionRNMHNCT02816320
Validity of Information Employed to Generate Standardized Mortality Ratios Using Hospital Administrative Databases (RNMH)
An observational study of Surgical Condition and Obstetrical Condition, run by Hospices Civils de Lyon.
Trial summary
In a retrospective cross-sectional study, investigators aimed to valid the variables employed to generate standardized mortality ratio from hospital administrative databases. For this purpose, investigators have compared those variables collected in administrative databases with the information available in patient… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Condition, Obstetrical Condition, Hospitalization in Acute Care
- What is being tested?
- Hospitalization
- How many people
- 715 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A random sample of patients who were hospitalized in 24 participating hospitals during the study period.
Who may be able to join
- All inpatients stays in acute care from high mortality diagnosis related groups (DRGs) registered in administrative databases of participating hospitals from January to December 2010.
Who cannot join
- Hospital participation refusal
About this study
In a retrospective cross-sectional study, investigators aimed to valid the variables employed to generate standardized mortality ratio from hospital administrative databases. For this purpose, investigators have compared those variables collected in administrative databases with the information available in patient medical record.
- Being tested
- Hospitalization
- Keywords
- hospital mortality, standardized mortality ratios, patient safety, healthcare quality, hospital performance, administrative data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HospitalizationOther
Patients who were hospitalized in acute care
| Study group | Role | What they receive |
|---|---|---|
| Inpatient stays | All patients who were hospitalized in participating hospitals in France during the study period were eligible for inclusion. Receives: Other: Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Death collected in hospital administrative databases at the end of in patient stay
Measured: within 90 days of admission (D90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical ConditionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816320
- Sponsor's protocol ID
- 69HCL15_0175
- Acronym
- RNMH
- Status last verified
- Apr 2019
- First submitted
- 22 Jun 2016
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Information Employed to Generate Standardized Mortality Ratios Using Hospital Administrative Databases (RNMH)
- ClinicalTrials.gov ID
- NCT02816320
- Acronym / sponsor ID
- RNMH / 69HCL15_0175
- Keywords
- hospital mortality, standardized mortality ratios, patient safety, healthcare quality, hospital performance, administrative data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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.
In a retrospective cross-sectional study, investigators aimed to valid the variables employed to generate standardized mortality ratio from hospital administrative databases. For this purpose, investigators have compared those variables collected in administrative databases with the information available in patient medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatient stays | – | Other: HospitalizationAll patients who were hospitalized in participating hospitals in France during the study period were eligible for inclusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A random sample of patients who were hospitalized in 24 participating hospitals during the study period.
Key inclusion criteria (1 listed)
- All inpatients stays in acute care from high mortality diagnosis related groups (DRGs) registered in administrative databases of participating hospitals from January to December 2010.
Key exclusion criteria (1 listed)
- Hospital participation refusal
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 |
|---|---|---|
| HospitalizationPatients who were hospitalized in acute care | Other | Inpatient stays |
Primary outcome
In-hospital mortality
Time frame: within 90 days of admission (D90)
Death collected in hospital administrative databases at the end of in patient stay
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 3 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Condition and Obstetrical Condition, run by Hospices Civils de Lyon.
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 1 inclusion and 1 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
In-hospital mortality (time frame: within 90 days of admission (D90)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2019.