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

Primary Purpose

Mental Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Shared care device in psychiatry (DSPP)
Usual Care
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Disorder focused on measuring Accessibility of health services, Access to psychiatric care, Consultation-liaison, General practitioner and psychiatrist collaboration, Care pathway

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shared care device in psychiatry (DSPP)

Care as usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of patients who had access to a consultation with a psychiatrist
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.

Secondary Outcome Measures

Number of days between M0 (GP consultation) and M1 (psychiatric consultation)
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
Number of passages to psychiatric emergencies
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
Number of suicide attempts
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
Mental health status by Symptom Checklist (SCL)
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.
Mental health status by Patient Health Questionnaire (PHQ)
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.
Duration of prescription of different drugs
Duration of prescription of a benzodiazepine, antidepressant, hypnotic and antipsychotic treatment passively collected on the bases of Health Insurance
Evaluation of compliance with antidepressant prescriptions
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
Number of prescription treatment of mental disorders
Number of prescription of a benzodiazepine, antidepressant, hypnotic and antipsychotic treatment passively collected on the bases of Health Insurance
Employment status
Occupation, without profession (Number and duration of sick leave within 6 months following M0, passively collected on the bases of Health Insurance)
Patient satisfaction
Patient satisfaction measured at 1 month of M0 by the Client Satisfaction Questionnaire (CSQ-8 scale)
Quality of life with EuroQol scale
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"
GP satisfaction
GP satisfaction measured by questionnaire
Incremental Cost-Utility
to determine Incremental Cost-Utility collected passively on the bases of Health Insurance, PMSI and DSPP
Cost-Effectiveness Ratios of Patient Management Strategies
to determine Cost-Effectiveness Ratios of Patient Management Strategies collected passively by data on the bases of Health Insurance, PMSI and DSPP
Production costs
to determine production costs collected passively on the bases of Health Insurance, PMSI and DSPP

Full Information

First Posted
April 16, 2018
Last Updated
May 11, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT03508518
Brief Title
Improving Access to Psychiatric Care for Patients in Primary Care
Acronym
DSPP-PSY
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
September 28, 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder
Keywords
Accessibility of health services, Access to psychiatric care, Consultation-liaison, General practitioner and psychiatrist collaboration, Care pathway

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shared care device in psychiatry (DSPP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Care as usual
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Shared care device in psychiatry (DSPP)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
psychiatric care available in the Haute Garonne: psychiatric consultation by a liberal psychiatrist or by a psychiatrist working in public health center.
Primary Outcome Measure Information:
Title
Number of patients who had access to a consultation with a psychiatrist
Description
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.
Time Frame
2 to 21 working days after inclusion
Secondary Outcome Measure Information:
Title
Number of days between M0 (GP consultation) and M1 (psychiatric consultation)
Description
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
Time Frame
6 months
Title
Number of passages to psychiatric emergencies
Description
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
Time Frame
6 months
Title
Number of suicide attempts
Description
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
Time Frame
6 months
Title
Mental health status by Symptom Checklist (SCL)
Description
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.
Time Frame
date of inclusion, 1 month and 6 months after inclusion
Title
Mental health status by Patient Health Questionnaire (PHQ)
Description
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.
Time Frame
date of inclusion, 1 month and 6 months after inclusion
Title
Duration of prescription of different drugs
Description
Duration of prescription of a benzodiazepine, antidepressant, hypnotic and antipsychotic treatment passively collected on the bases of Health Insurance
Time Frame
date of inclusion, 1 month and 6 months after inclusion
Title
Evaluation of compliance with antidepressant prescriptions
Description
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
Time Frame
date of inclusion, 1 month and 6 months after inclusion
Title
Number of prescription treatment of mental disorders
Description
Number of prescription of a benzodiazepine, antidepressant, hypnotic and antipsychotic treatment passively collected on the bases of Health Insurance
Time Frame
date of inclusion, 1 month and 6 months after inclusion
Title
Employment status
Description
Occupation, without profession (Number and duration of sick leave within 6 months following M0, passively collected on the bases of Health Insurance)
Time Frame
6 months
Title
Patient satisfaction
Description
Patient satisfaction measured at 1 month of M0 by the Client Satisfaction Questionnaire (CSQ-8 scale)
Time Frame
1 month
Title
Quality of life with EuroQol scale
Description
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"
Time Frame
6 months
Title
GP satisfaction
Description
GP satisfaction measured by questionnaire
Time Frame
6 months
Title
Incremental Cost-Utility
Description
to determine Incremental Cost-Utility collected passively on the bases of Health Insurance, PMSI and DSPP
Time Frame
6 months
Title
Cost-Effectiveness Ratios of Patient Management Strategies
Description
to determine Cost-Effectiveness Ratios of Patient Management Strategies collected passively by data on the bases of Health Insurance, PMSI and DSPP
Time Frame
6 months
Title
Production costs
Description
to determine production costs collected passively on the bases of Health Insurance, PMSI and DSPP
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Prébois, MD
Phone
05 34 55 75 75
Ext
33
Email
prebois.s@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Charline Daguzan, PhD
Phone
05 61 77 84 90
Ext
33
Email
daguzan.c@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Prébois, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Prébois, MD
Phone
05 34 55 75 75
Ext
33
Email
prebois.s@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Charline Daguzan, PhD
Phone
05 61 77 84 96
Ext
33
Email
daguzan.c@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Access to Psychiatric Care for Patients in Primary Care

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