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.
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.
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)
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.
- First posted23 Jun 2020
- Study startJul 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 12,551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine CHEVREUL, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Care Pathways Between Ambulatory and Hospital Settings in Mental Health Care
- ClinicalTrials.gov ID
- NCT04442880
- Acronym / sponsor ID
- PAPRICA / PREPS-14-0028
- Conditions
- Mental Disorder
- Keywords
- mental health, care pathways
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,551 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 23 Jun 2020 (actual)
- 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors associated with the probability to have a certain type of care pathways with a given quality and similar characteristics
Time frame: 24 months
Results of the multivariate regression analysis
1 secondary outcome
Identification of specific care pathways, their quality, and analysis of the variations
Time frame: 24 months
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 25 Jun 2020.
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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.
Karine CHEVREUL, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
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.