Mental DisorderDSPP-PSYNCT03508518
Improving Access to Psychiatric Care for Patients in Primary Care
A study testing Shared care device in psychiatry (DSPP) in people with Mental Disorder, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Shared care device in psychiatry (DSPP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2018to 1 Aug 2023
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient with ongoing psychiatric follow-up
- Patient unable to answer questionnaires (unable to read or write)
- Patients receiving a measure of legal protection
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mental Disorder
- Being tested
- Shared care device in psychiatry (DSPP), Usual Care
- Keywords
- Accessibility of health services, Access to psychiatric care, Consultation-liaison, General practitioner and psychiatrist collaboration, Care pathway
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared care device in psychiatry (DSPP)Other
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
Usual CareOther
psychiatric care available in the Haute Garonne: psychiatric consultation by a liberal psychiatrist or by a psychiatrist working in public health center.
| Study group | Role | What they receive |
|---|---|---|
| Shared care device in psychiatry (DSPP) | Experimental | 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. Receives: Other: Shared care device in psychiatry (DSPP) |
| Care as usual | Active comparator | 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 Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 to 21 working days after inclusion
Secondary outcomes (15)
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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.
Measured: date of inclusion, 1 month and 6 months after inclusion
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.
Measured: date of inclusion, 1 month and 6 months after inclusion
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
Measured: date of inclusion, 1 month and 6 months after inclusion
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
Measured: date of inclusion, 1 month and 6 months after inclusion
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
Measured: date of inclusion, 1 month and 6 months after inclusion
Employment status
Occupation, without profession (Number and duration of sick leave within 6 months following M0, passively collected on the bases of Health Insurance)
Measured: 6 months
Patient satisfaction
Patient satisfaction measured at 1 month of M0 by the Client Satisfaction Questionnaire (CSQ-8 scale)
Measured: 1 month
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"
Measured: 6 months
GP satisfaction
GP satisfaction measured by questionnaire
Measured: 6 months
Incremental Cost-Utility
to determine Incremental Cost-Utility collected passively on the bases of Health Insurance, PMSI and DSPP
Measured: 6 months
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
Measured: 6 months
Production costs
to determine production costs collected passively on the bases of Health Insurance, PMSI and DSPP
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start28 Aug 2018
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Why it stopped: recruitment difficulties
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 University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Sophie Prébois, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508518
- Sponsor's protocol ID
- RC31/17/0357
- Other IDs
- 2017-A03127-46
- Acronym
- DSPP-PSY
- Status last verified
- Dec 2023
- First submitted
- 16 Apr 2018
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03508518
- Acronym / sponsor ID
- DSPP-PSY / RC31/17/0357
- Conditions
- Mental Disorder
- Keywords
- Accessibility of health services, Access to psychiatric care, Consultation-liaison, General practitioner and psychiatrist collaboration, Care pathway
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 25 Apr 2018 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared care device in psychiatry (DSPP) | Experimental | Other: 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. |
| Care as usual | Active comparator | Other: Usual CarePatient 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Patient with ongoing psychiatric follow-up
- Patient unable to answer questionnaires (unable to read or write)
- Patients receiving a measure of legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Shared care device in psychiatry (DSPP) |
| Usual Carepsychiatric care available in the Haute Garonne: psychiatric consultation by a liberal psychiatrist or by a psychiatrist working in public health center. | Other | Care as usual |
Primary outcome
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.
15 secondary outcomes
Number of days between M0 (GP consultation) and M1 (psychiatric consultation)
Time frame: 6 months
Number of passages to psychiatric emergencies
Time frame: 6 months
Number of suicide attempts
Time frame: 6 months
Mental health status by Symptom Checklist (SCL)
Time frame: 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
Duration of prescription of different drugs
Time frame: 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
Number of prescription treatment of mental disorders
Time frame: date of inclusion, 1 month and 6 months after inclusion
Employment status
Time frame: 6 months
Patient satisfaction
Time frame: 1 month
Quality of life with EuroQol scale
Time frame: 6 months
GP satisfaction
Time frame: 6 months
Incremental Cost-Utility
Time frame: 6 months
Cost-Effectiveness Ratios of Patient Management Strategies
Time frame: 6 months
Production costs
Time frame: 6 months
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Sophie Prébois, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared care device in psychiatry (DSPP) in people with Mental Disorder, run by University Hospital, Toulouse at 1 site in France.
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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
Number of patients who had access to a consultation with a psychiatrist (time frame: 2 to 21 working days after inclusion). 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 19 Dec 2023.