Improving Access to Psychiatric Care for Patients in Primary Care (DSPP-PSY)

December 12, 2023 updated by: University Hospital, Toulouse

Improving Access to Psychiatric Care and the Fluidity of Care Pathways for Patients Suffering From Mental Disorders in Primary Care in France: Evaluation of a Psychiatric Consultation-liaison System

Getting a consultation with a psychiatrist within an appropriate time is one of the main issues reported by general practitioners (GP) for patients suffering from mental disorders in primary care. Consultation liaison in psychiatry is a system focused on general medicine-psychiatry collaboration. The aim of the present study is to evaluate the impact of the consultation-liaison on the adequacy of the access time to a psychiatric consultation according to the degree of urgency evaluated by the GP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Faced with the saturation of the psychiatric care system, who recognizes the key role of the GP in mental health. Three-quarters of prescriptions for antidepressants and anxiolytics are performed by GPs, but less than one in four people with depression have been diagnosed and treated appropriately. The GPs describe difficulties in accessing psychiatric professionals and in particular to obtain a quick consultation with a psychiatrist. In different countries, psychiatric consultation-liaison (CL), centered on the collaboration of general medicine and psychiatry, have emerged. Two meta-analyzes and a Cochrane review were conducted on CL but no clinical trials were conducted in France. CL seems to improve patients' health at 3 months as well as their satisfaction and adherence to care. Results regarding the improvement of prescriptions from GP are encouraging. Better clinical trials are being requested and a need for medico-economic studies is also identified.

In France, a psychiatry CL was born in Toulouse in 2017, the "DSPP". The present study plans a 2 groups randomized clinical trial, one group of GPs having access to DSPP, the other not. For a period of 3 months, the GPs propose to any patient, for whom they want a psychiatric consultation, to participate in the study and address him/her to a psychiatrist. The DSPP is an evaluation center without long-term patient follow-up. Only patient referred by his/her GP can get into the DSPP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Toulouse, France, 31059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 15 years patient or older:
  • presenting mental suffering or a frequent or severe mental disorder
  • having consulted his GP who ask for psychiatric consultation
  • having given its consent for the use of its medico-administrative data
  • affiliated with the general health insurance scheme
  • of which the GP is from Haute Garonne and is voluntary to participate in the study
  • Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research) and by one of the parents for minor participants

Exclusion Criteria:

  • Patient with ongoing psychiatric follow-up
  • Patient unable to answer questionnaires (unable to read or write)
  • Patients receiving a measure of legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Shared care device in psychiatry (DSPP)
System focused on collaboration between general medicine (GP) and psychiatry, offering psychiatric assessment consultations and guidance for patient addressed by his/her GP. Referrals are made to the GP with support for care or the patient can be oriented to routine psychiatric care.
Other: Shared care device in psychiatry (DSPP)
The GPs of the intervention group will be able to refer their patients to the DSPP or to the routine care. The patient has a nursing telephone interview prior to one or few more psychiatric consultations. The time to obtain the psychiatric consultation is measured into the 2 groups. In both groups, questionnaires will be sent to the patient and their medico-administrative data will be collected passively over a period of 6 months after inclusion
Active Comparator: Care as usual

Patient will have usual care :

Psychiatric care available in the Haute Garonne: psychiatric consultation by a liberal psychiatrist or by a psychiatrist working in public health center
Other: Usual Care
psychiatric care available in the Haute Garonne: psychiatric consultation by a liberal psychiatrist or by a psychiatrist working in public health center.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients who had access to a consultation with a psychiatrist
Time Frame: 2 to 21 working days after inclusion
Number of patients who had access to a consultation with a psychiatrist within 2 working days following the GP consultation for patients whose GP wishes an "urgent" consultation, within 7 working days for a "quick" consultation and within 21 working days for a "non-urgent" consultation.
2 to 21 working days after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of days between M0 (GP consultation) and M1 (psychiatric consultation)
Time Frame: 6 months
Number of days between M0 (GP consultation) and M1 (psychiatric consultation) collected passively on the bases of Health Insurance, Information Systems Medicalization Program (PMSI) and DSPP
6 months
Number of passages to psychiatric emergencies
Time Frame: 6 months
Number of passages to psychiatric emergencies within 6 months M0 passively collected on the basis of the PMSI (Information Systems Medicalization Program) of psychiatric emergencies
6 months
Number of suicide attempts
Time Frame: 6 months
Number of suicide attempts and suicides within 6 months following M0 passively collected on the basis of the PMSI of the psychiatric emergencies and the Health Insurance
6 months
Mental health status by Symptom Checklist (SCL)
Time Frame: date of inclusion, 1 month and 6 months after inclusion

Mental health status measured at M0, 1 month and 6 months by questionnaires hand-delivered by the GP at M0 and sent at 1 and 6 months :

- SCL-90-R scale: Scale exploring 9 symptomatic dimensions (somatization, obsession-compulsion, sensory traits, depression, anxiety, hostility, phobic anxiety, paranoid ideals, psychotic traits) by Likert scale in 5 points. Passing 15min.
date of inclusion, 1 month and 6 months after inclusion
Mental health status by Patient Health Questionnaire (PHQ)
Time Frame: date of inclusion, 1 month and 6 months after inclusion

Mental health status measured at M0, 1 month and 6 months by questionnaires hand-delivered by the GP at M0 and sent at 1 and 6 months :

- the PHQ-9 scale for the diagnosis of major depressive episode and the intensity of depression. 9 questions are rated from 0 to 3 by the patient, ie a score of severity ranging from 0 to 27.
date of inclusion, 1 month and 6 months after inclusion
Duration of prescription of different drugs
Time Frame: date of inclusion, 1 month and 6 months after inclusion
Duration of prescription of a benzodiazepine, antidepressant, hypnotic and antipsychotic treatment passively collected on the bases of Health Insurance
date of inclusion, 1 month and 6 months after inclusion
Evaluation of compliance with antidepressant prescriptions
Time Frame: date of inclusion, 1 month and 6 months after inclusion
Composite criterion for the evaluation of compliance with antidepressant prescriptions including drug type (first-line serotonin reuptake inhibitors (IRS): 0 or 1) and duration (6 months minimum: 0 or 1) with a total score of 0 to 2
date of inclusion, 1 month and 6 months after inclusion
Number of prescription treatment of mental disorders
Time Frame: date of inclusion, 1 month and 6 months after inclusion
Number of prescription of a benzodiazepine, antidepressant, hypnotic and antipsychotic treatment passively collected on the bases of Health Insurance
date of inclusion, 1 month and 6 months after inclusion
Employment status
Time Frame: 6 months
Occupation, without profession (Number and duration of sick leave within 6 months following M0, passively collected on the bases of Health Insurance)
6 months
Patient satisfaction
Time Frame: 1 month
Patient satisfaction measured at 1 month of M0 by the Client Satisfaction Questionnaire (CSQ-8 scale)
1 month
Quality of life with EuroQol scale
Time Frame: 6 months
Quality of life measured by the EuroQol (EQ-5D-5L) scale at M0 and 6 months by a clinical researcher by phone The EQ-5D-5L scale consists of 2 pages, a descriptive system EQ-5D and a visual analogue scale EQ . The descriptive system explores the following five dimensions: mobility, autonomy, usual activities, pain / discomfort and anxiety / depression. Each dimension is rated in 5 levels . The visual analogue scale is a vertical scale where the endpoints are labeled "best health imaginable" and "worst health imaginable"
6 months
GP satisfaction
Time Frame: 6 months
GP satisfaction measured by questionnaire
6 months
Incremental Cost-Utility
Time Frame: 6 months
to determine Incremental Cost-Utility collected passively on the bases of Health Insurance, PMSI and DSPP
6 months
Cost-Effectiveness Ratios of Patient Management Strategies
Time Frame: 6 months
to determine Cost-Effectiveness Ratios of Patient Management Strategies collected passively by data on the bases of Health Insurance, PMSI and DSPP
6 months
Production costs
Time Frame: 6 months
to determine production costs collected passively on the bases of Health Insurance, PMSI and DSPP
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sophie Prébois, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC31/17/0357
  • 2017-A03127-46 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mental Disorder

Clinical Trials on Shared care device in psychiatry (DSPP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings