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Mental DisorderPAPRICANCT04442880

Patient Care Pathways Between Ambulatory and Hospital Settings in Mental Health Care

An observational study of Mental Disorder, run by Assistance Publique - Hôpitaux de Paris.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mental Disorder
How many people
12,551 participants
Where
No sites listed yet
Study dates
Jul 2015to Apr 2018
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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: 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 Non-inclusion 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

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read more

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.

Read the detailed description

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, each presenting several types of care (e.g. for full time care: hospitalization or treatment in a therapeutic apartment). This wide variety of treatment methods is associated with significant variations in the use of each of them, which can lead patients with similar mental disorders to follow different care pathways. This suggests that one of them may have a better quality of care than the others and therefore that the variation in care pathways is associated with a loss of equity and decreased chances for some patients, as well as a non-optimal use of resources and inefficiency for the health care system. Several categories of factors are associated with the variation in care pathways: the clinical and socioeconomic characteristics of patients, the characteristics of the mental health care providers and those of the health and health and social care available which can provide care complementary to that of psychiatry, as well as the characteristics of the environment in terms of living conditions (urban development and unemployment rate for example).

While it is not possible to act in the short term on the characteristics of patients or of their living conditions, it seems essential to identify the characteristics of mental health care providers and of the surrounding care on offer associated with the variation in care pathways, as they may be subject to reforms to improve the quality of care.

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 secondary objectives are:

  • to define a method to elaborate patients' care pathways;
  • to assess the respective quality of each possible pathway;
  • to build a typology of care pathways with similar characteristics;
  • to describe the variability in care pathways and in their associated quality;
  • to identify other factors associated with the variability in care pathways and in their quality (characteristics of the patients and their environment).

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).

Secondary endpoints will include:

  • Identification of individualized care pathways
  • Level of quality of each care pathways in ordered classes
  • Typology of similar care pathways, and for each category: proportion of the different care pathways within this category, proportion in each quality level, intensity, frequency and diversity of care
  • Clinical and socioeconomic characteristics of patients and of their environment significantly associated with the different typology of care pathways and with the different levels of quality of care (in a multivariate modelling allowing an adjustment to 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.

Care pathways will first be constructed with an analysis of state sequences. They will then be given a quality level: a group of experts will be appointed to define specific criteria to assess quality. The typology of care pathways will then be constructed via an ascending hierarchical classification based on a distance calculation taking into account the temporal ordering of care and descriptive analysis of the groups obtained. Finally, we will identify factors associated with the variability in care pathways and in their quality using multinomial logistic regressions.

The identification of factors associated with the variability in care pathways and in their quality, in particular factors linked to the organization of mental health care and to the complementary health and health and social care provision, will lead to recommendations on how to improve the quality of care and the efficiency of the health care system. Ultimately, this will contribute to the reduction of geographic and social health inequalities.

Conditions
Mental Disorder
Keywords
mental health, care pathways
Medical subject headings
Mental Disorders, Psychological Well-Being

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 months

Secondary outcomes (1)
  1. Identification of specific care pathways, their quality, and analysis of the variations

    Results of the multivariate regression analysis

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2020
  2. Study startJul 2015
  3. Primary completionApr 2018
  4. Study completionApr 2018

Resources

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
12,551 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04442880
Sponsor's protocol ID
PREPS-14-0028
Acronym
PAPRICA
Status last verified
Jun 2020
First submitted
19 Jun 2020
Last updated
25 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Disorder, run by Assistance Publique - Hôpitaux de Paris.

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 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 25 Jun 2020. 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?

Factors associated with the probability to have a certain type of care pathways with a given quality and similar characteristics (time frame: 24 months). 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 25 Jun 2020.

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