About this trial
The pilot study on the impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French-speaking Switzerland (PLIMeC-P), is a mixed method randomized controlled trial. The investigated health-related intervention is a brief Consultation-Liaison (CL) psychiatry intervention in primary care.
Primary Care Physicians (PCPs) have a key role in preventing, detecting, and managing mental disorders. Therefore, the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges. It is well demonstrated that multidisciplinary interventions improve the efficacy of mental health care, CL psychiatry being one such type of intervention. Therefore, community CL-psychiatry, for example in private primary care group practices, are rare. The impact of such community, primary care CL-psychiatry interventions, should be investigated.
The mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings, for newly reported mental illness, versus a Treatment As Usual (TAU) control arm. The intervention consists of a CL-psychiatric intervention into private medical practices, provided to patients suffering from mental health problems, a group of patients generally under-treated. The CL-psychiatrist will receive and discuss PCPs' referrals for patients with mental distress, who don't have a psychiatric follow-up. After a brief intervention (1-4 sessions), feedback conjoint (PCP-psychiatrist) session will be organized, to complete the intervention and provide proposals.
The pilot study (PLIMeC-P) will determine whether the main planned study (PLIMeC) is feasible and practicable. It will be conducted on two sites, the Neuchâtel Psychiatry Centre (CNP) and the North-west Adult Psychiatry Service (SPANO), Department of Psychiatry of CHUV, Yverdon. For the pilot study (PLIMeC-P), 15 eligible participants are expected for each group, 30 participants in total. They will be recruited in three private primary care group practices. After eligibility and randomization 15 participants will be included for the intervention arm (brief CL-psychiatric intervention) and 15 for the control arm (TAU). The expected number of participants for the main trial (PLIMeC) will be estimated through analysis of the initial results of the PLIMeC-P.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged more than 18 years
Signed informed consent to study protocol
Referred by their PCP due to mental distress, psychiatric symptoms, or complexity of medical care
Having fluent knowledge of the local language or being accompanied by an interpreter
Disqualifiers
Not being able to give an informed consent and follow the procedure of the study (due to dementia, restriction of intellectual capacity, acute confusional state, language problem)
Presenting an acute psychotic symptomatology, a hetero-aggression risk or an acute suicidality
Having an ongoing psychiatric follow-up
Trial design
Parallel
Treatments tested in this trial
Intervention arm - Consultation-Liaison (CL) brief psychiatric intervention in primary care settings
Other interventionThe CL brief psychiatric intervention (2 months) in the primary setting will consist of 3 different phases: 1. A direct referral of their PCP to the practice's CL psychiatrist will be held directly after the inclusion of the patient to the intervention arm, by conducting a clinical exchange (by oral or by mail) with the latter. 2. The CL psychiatrist will organize rapidly (in a delay of 1-2 weeks) a first session and will perform 1 to 4 psychiatric sessions, depending on the participant's needs. These sessions will take place in his/her consultation room, located in the referring PCP's practice, and will be completed in less than 2 months. No intervention guide will be provided to perform these sessions. 3. A joint feedback session between the PCP, the participant, and the CL psychiatrist will be organized (2 months after the first psychiatric session), during which the CL psychiatrist will make restitution of his/her proposals, from a biopsychosocial perspective.
Control Arm - Treatment As Usual (TAU)
Other interventionPCPs will explain to the participants that they will treat their psychological suffering, by providing the usual care for patients with psychiatric co-morbidities. Treatment as usual (TAU) by the PCP may involve supportive care (psychoeducation, psychotherapeutic support, social interventions, etc.), referral to a mental health provider (psychotherapist, psychiatrist, psychiatric nurse, etc.), treatment with psychotropic drugs, hypnosis, acupuncture, relaxation, etc. So as to facilitate their task, PCPs participating in this study will be provided with a list of mental health workers that they could contact.
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the feasibility of the main PLIMeC study
The feasibility of the main study will be measured by the percentage (%) of participants in the pilot study who will have completed all the planned assessments during the 4 time points (T0 - T3). Feasibility will be assured if a percentage greater than 50% is obtained.
Mental health - psychiatric symptoms
The evolution of participants' psychiatric symptoms with the Primary Care Evaluation of Mental Disorders (PRIME-MD) scale and more specifically with its three sub-scales: Patient Health Questionnaire Somatic (PHQ-15 score ranges from 0 to 30), Anxiety (GAD-7 score ranges from 0 to 21), and Depressive Symptom Scales (PHQ-9 score ranges from 0 to 27). Regarding each of the 3 sub-scales, a reduction of more than 5 points will be deemed as clinically relevant.
Mental health - Quality of life
The evolution of participants' quality of life with the WHOQOL-BREF questionnaire, focusing on the psychological domain (Domain - 2 score ranges from 6 to 30). WHOQOL-BREF increase of 2.8 points on the psychological domain will be deemed as clinically relevant.
Mental health - Self-report questionnaire
A self-report questionnaire, which will include measures on demographic, psychiatric, and quality of life variables.
Secondary outcomes
The lived experience of the participants
The lived experience of participants will be assessed by performing semi-structured interviews: The semi-structured interviews conducted with the participants will focus on the encountered difficulties facing mental health problems (stigmatization, uncertainty, poly-comorbidity, poly-medication, lack of accessibility, etc.) and the effect on the doctor-patient relationship.
The lived experience of the implicated clinicians
The lived experience of the implicated clinicians (PCPs' and CL psychiatrists') will be assessed by performing semi-structured interviews: The semi-structured interviews conducted with the implicated clinicians will focus on the barriers and/or the facilitators and relational interactions during a psychiatric consultation-liaison intervention in primary care.
Other outcomes
Healthcare system complexity - Quantitative assessment
The healthcare system complexity will be assessed by using questions 13,14,15,16,20 of the INTERMED Self-Assessment (score ranges from 0 to 3).
Healthcare system complexity - qualitative assessment
The qualitative assessment will include the participants' mental health care needs and the PCPs' mental health service needs. Semi-structured interviews will be carried out with the participants and the implicated clinicians.
Access to mental healthcare
The access to mental healthcare will be assessed by using question 24 of the WHOQOL-Bref questionnaire (score ranges from 1 to 5).
Sponsors and contacts
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Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Lead sponsor
Neuchâtel Psychiatry Centre (CNP)
Collaborator
University of Lausanne Hospitals
Collaborator