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Trial record 40 of 4736 for:    Recruiting, Not yet recruiting, Available Studies | "Psychotic Disorders"

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

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ClinicalTrials.gov Identifier: NCT03508518
Recruitment Status : Not yet recruiting
First Posted : April 25, 2018
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Mental Disorder Other: Shared care device in psychiatry (DSPP) Other: Usual Care Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.


  5. 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.


  6. 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

  7. 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

  8. 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

  9. 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)

  10. Patient satisfaction [ Time Frame: 1 month ]
    Patient satisfaction measured at 1 month of M0 by the Client Satisfaction Questionnaire (CSQ-8 scale)

  11. Quality of life [ 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"

  12. GP satisfaction [ Time Frame: 6 months ]
    GP satisfaction measured by questionnaire

  13. Incremental Cost-Utility [ Time Frame: 6 months ]
    to determine Incremental Cost-Utility collected passively on the bases of Health Insurance, PMSI and DSPP

  14. 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

  15. Production costs [ Time Frame: 6 months ]
    to determine production costs collected passively on the bases of Health Insurance, PMSI and DSPP



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508518


Contacts
Contact: Sophie Prébois, MD 05 34 55 75 75 ext 33 prebois.s@chu-toulouse.fr
Contact: Charline Daguzan, PhD 05 61 77 84 90 ext 33 daguzan.c@chu-toulouse.fr

Locations
France
University Hospital Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Sophie Prébois, MD    05 34 55 75 75 ext 33    prebois.s@chu-toulouse.fr   
Contact: Charline Daguzan, PhD    05 61 77 84 96 ext 33    daguzan.c@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Ministry of Health, France
Investigators
Principal Investigator: Sophie Prébois, MD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03508518     History of Changes
Other Study ID Numbers: RC31/17/0357
2017-A03127-46 ( Other Identifier: ID-RCB )
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Accessibility of health services
Access to psychiatric care
Consultation-liaison
General practitioner and psychiatrist collaboration
Care pathway

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders