Mental Disorder Clinical Trial
— PAPRICANCT number | NCT04442880 |
Other study ID # | PREPS-14-0028 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | April 2018 |
Verified date | June 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In France, mental health care is provided by public and private hospitals and is organized
around three main categories of care: ambulatory, full-time and part-time. This wide variety
of treatment methods can lead patients with similar mental disorders to follow different care
pathways. As a result, a patient may have a higher quality of care than others, which would
result in a loss of equity and reduced opportunities for patients.
The primary objective of the study is to identify the organizational factors and the
characteristics of mental health care providers and of the surrounding care provision
associated with the variability in care pathways for mental health care and in their quality.
The primary endpoint is the organizational factors associated with the different typology of
care pathways and with the different levels of quality of care (in a multivariate modelling
allowing an adjustment on the other factors).
In order to do so, a cohort of patients will be constituted using French administrative
databases. Mental health care consumption will be obtained via data from the ambulatory
claims database (SNIIRAM) along with hospital discharge databases for psychiatric care
(RIM-P) and non-psychiatric acute care (PMSI-MCO). These databases will be supplemented by
other linkable databases in order to describe the clinical and socioeconomic characteristics
of the patients and environment, as well as the characteristics of care provision and
available health and social care.
All adult patients with a full-time or part-time admission to one of seven public psychiatric
hospitals participating to the study or admitted to a private psychiatric hospital located on
their health territories will be included in the study. Patients not residing in the health
territory of those hospitals included in the study as well as patients treated exclusively in
ambulatory care settings will be excluded.
Using data from the database and the opinion of key experts, a classification of care
pathways will be established in order to identify the factors associated with the variability
of the pathways and their quality with multinomial logistic regressions.
The identification of factors associated with the variability in care pathways will lead to
recommendations on how to improve the quality of care and the efficiency of the health care
system.
Status | Completed |
Enrollment | 12551 |
Est. completion date | April 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All adult patients who received full-time or part-time care in one of the 7 public mental health care facilities participating to the study, as well as patients followed in private mental health care facilities located in the same health territories Exclusion Criteria: - Patients not residing in the health territory of one of the 7 public mental health care establishments included in the study; - Patients treated exclusively on an outpatient basis |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Factors associated with the probability to have a certain type of care pathways with a given quality and similar characteristics | Results of the multivariate regression analysis | 24 months | |
Secondary | Identification of specific care pathways, their quality, and analysis of the variations | Results of the multivariate regression analysis | 24 months |
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