NCT02617251

Brief Summary

Many studies have shown that deprived patients consumed more healthcare resources than non-deprived patients, in particular in terms of increased length of stay (LOS) and readmission rates, which has an impact on hospital efficiency and the healthcare system as a whole. There are many types of indicators available to assess deprivation in a hospital setting and French decision makers are currently using reliance on public aids to allocate additional funding to hospitals, based on the percentage of deprived patients they admit. However there are limits to this method: it only assesses one dimension of deprivation, the target population often does not know about the existence of those aids, and they have a clear threshold effect. An alternative solution is to use ecological deprivation indices which are obtained by aggregating different variables measured at a specific time and place, i.e. the patient's place of residence at the time of care. One such index, the FDep , was developed specifically in France, although others such as the Carstairs index and the European deprivation index also exist. The primary objective of this study is to study the association between deprivation, measured by the FDep, and hospital care efficiency in paediatric and neonatology patients, measured by the difference between patient LOS and the national average LOS of their diagnosis-related group, DRG). The secondary objectives are to carry out a budget impact analysis on the impact of deprivation for hospitals with a paediatric or neonatology ward, to study the association between deprivation and readmission at 15 days, to study the relation between FDep and the currently used deprivation indicators, and to assess the added value of the FDep compared to those indicators and whether or not it should be used in routine practice. In order to do so, an exhaustive retrospective study using the French hospital claims database will be carried out for the years 2012-2014. Deprivation indices will be calculated based on patients' postcode. The primary endpoint will be calculated using the national LOS present in the French national cost study. Similarly, the budget impact will look at the difference between production costs derived from the national cost study after adjusting for LOS and the statutory health insurance's tariffs, which will allow us to assess whether a hospital stay is associated with a gain, a loss or is budget-neutral for the hospital. Readmissions at 15 days will be identified through record linkage. Descriptive analyses will summarise both hospital and patient characteristics. Uni- and bivariate analyses will be carried out by focusing of the variables of interest (e.g. average deprivation index by legal status of the hospital, mean LOS depending on the number of paediatric beds etc.). The deprivation index will be divided into quantiles as is the norm and the endpoints will be assessed for each of those quantiles. An ANOVA (or a Kruskal-Wallis test if the ANOVA hypotheses are not met) will test whether the results differ between each quantile. For readmission rates, a Chi² test will be performed. In order to study the association between deprivation and the endpoints, the investigators will model each endpoint using as the main explanatory variable the deprivation index. Three main types of explanatory variables will be added to the model: patient characteristics (age, sex, severity level etc.), hospital characteristics (legal status, size, number of full-time equivalent etc.) and environment/context characteristics (number of paediatricians for 1,000 inhabitants, rural vs. urban area etc.). In order to assess the added benefit of using the deprivation index vs. the current indicators, a sub-cohort will be constructed in Paris teaching hospitals (AP-HP) as unfortunately, whether the patient receives public aids is not present in the hospital claim database but is available only at the local level. The investigators will look at the distribution of patients with public aids in each quantile of the deprivation index and run the previous models using the two types of indicators one after the other and comparing the statistical performance of each pair of models.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,500,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2018

Enrollment Period

3.7 years

First QC Date

November 19, 2015

Last Update Submit

February 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital stay duration for participants

    30 months

Study Arms (2)

neonatology patients

neonatology patients

Other: No intervention

paediatric patients

paediatric patients

Other: No intervention

Interventions

neonatology patientspaediatric patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospitalization in neonatology and pediatrics

You may qualify if:

  • Neonatology population
  • Hospital stay present in the national hospital claims database in 2012-2014
  • With a DRG and/or principal diagnosis related to neonatology
  • In a hospital with a neonatology ward (including ICU)
  • Age \<28 days
  • Paediatric population
  • Hospital stay present in the national hospital claim database in 2012-2014
  • In a hospital with at least one paediatric department
  • Age \< 15 years old

You may not qualify if:

  • Day admissions
  • Stays with error codes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

Related Publications (1)

  • Michel M, Alberti C, Carel JC, Chevreul K. Association of Pediatric Inpatient Socioeconomic Status With Hospital Efficiency and Financial Balance. JAMA Netw Open. 2019 Oct 2;2(10):e1913656. doi: 10.1001/jamanetworkopen.2019.13656.

Study Officials

  • Jean-Claude Carel, MD-PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 30, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 3, 2023

Record last verified: 2018-02

Locations