Validity of Information Employed to Generate Standardized... | NCT02816320

Studies
Validity of Information Employed to Generate Standardized Mortality Ratios Using Hospital Administrative Databases (RNMH)

NCT02816320

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Apr 3, 2019Actual

Enrollment

715Actual

Phase

Not provided

Conditions

Surgical Condition
Obstetrical Condition
Hospitalization in Acute Care

Interventions

Hospitalization

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jun 24, 2016

First Posted Date

Jun 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2019

Last Update Posted Date

Apr 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 medical record.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

715Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inpatient stays		All patients who were hospitalized in participating hospitals in France during the study period were eligible for inclusion.	Other: Hospitalization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hospitalization	Other	Patients who were hospitalized in acute care	Inpatient stays

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-hospital mortality	Death collected in hospital administrative databases at the end of in patient stay	within 90 days of admission (D90)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Hospital participation refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

A random sample of patients who were hospitalized in 24 participating hospitals during the study period.

Sampling Method

Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D006760	Hospitalization

Ancestor Terms

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided