protocolSection identificationModule nctId: NCT06377189, orgStudyIdInfo id: 2023-01910, briefTitle: Psychiatric Consultation-Liaison Intervention in Primary Care: A Pilot Study, acronym: PLIMeC-P, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, class: OTHER, collaborators name: Neuchâtel Psychiatry Centre (CNP), collaborators name: University of Lausanne Hospitals, descriptionModule briefSummary: 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., conditionsModule conditions: Mental Health Issue, conditions: Depression/Anxiety, conditions: Quality of Life, conditions: Psychosomatic Disorders, conditions: Patients Lived Experiences, conditions: Doctor-Patient Relation, conditions: Collaboration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In order to answer the research question of the PLIMeC-P (pilot study), aiming to determine the feasibility and practicability of the main PLIMeC study, in the initial phase, the statistical procedures will be limited to questions of practicability and quality.For the main PLIMeC study we will use a mixed method approach, combining various data collection and analysis methods (qualitative and quantitative). Quantitative methods will be used to obtain a breadth of understanding of the phenomenon of interest, and qualitative methods will be used to explore and obtain depth of this understanding. More specifically, the combination of methods will be used for complementarity, using qualitative data to examine how the participants, patients and healthcare providers, experience this specific CL-psychiatric intervention and quantitative methods to examine the impact of such an intervention on patients. In data analysis, the priority among the two methods will be equal., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Intervention arm - Consultation-Liaison (CL) brief psychiatric intervention in primary care settings, interventions name: Control Arm - Treatment As Usual (TAU), outcomesModule primaryOutcomes measure: Evaluate the feasibility of the main PLIMeC study, primaryOutcomes measure: Mental health - psychiatric symptoms, primaryOutcomes measure: Mental health - Quality of life, primaryOutcomes measure: Mental health - Self-report questionnaire, secondaryOutcomes measure: The lived experience of the participants, secondaryOutcomes measure: The lived experience of the implicated clinicians, otherOutcomes measure: Healthcare system complexity - Quantitative assessment, otherOutcomes measure: Healthcare system complexity - qualitative assessment, otherOutcomes measure: Access to mental healthcare, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Primary Care and Public Health (Unisanté) - Sponsorship / Not recruiting site, city: Lausanne, state: Vaud, zip: 1010, country: Switzerland, geoPoint lat: 46.516, lon: 6.63282, locations facility: Service de psychiatrie de l'adulte nord ouest (SPANO) Département de psychiatrie - CHUV (DP-CHUV), city: Yverdon-les-Bains, state: Vaud, zip: 1400, country: Switzerland, contacts name: Julien Elowe, MD, role: CONTACT, phone: 0041 21 314 54 38, email: Julien.Elowe@chuv.ch, contacts name: Julien Elowe, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Gerrit Weber, MD, role: SUB_INVESTIGATOR, geoPoint lat: 46.77852, lon: 6.64115, locations facility: Centre Neuchâtelois de Psychiatrie (CNP), city: Neuchâtel, zip: 2000, country: Switzerland, contacts name: Stéphane Saillant, PD, role: CONTACT, phone: 0041 32 755 15 15, email: stephane.saillant@cnp.ch, contacts name: Stéphane Saillant, PD, role: PRINCIPAL_INVESTIGATOR, contacts name: Julie Gavin-Ramain, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 46.99179, lon: 6.931, hasResults: False