Psychiatric Consultation-Liaison Intervention in Primary Care: A Pilot Study

NCT06377189 | Recruiting

• 1 other identifier: 2023-01910
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Mental Health Issue; Depression/Anxiety; Quality of Life; Psychosomatic Disorders; Patients Lived Experiences; Doctor-Patient Relation; Collaboration

Keywords

Consultation-Liaison psychiatry; Mental health; Mixed method; Primary Care; Healthcare Complexity

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to 20 months

• 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.

  After enrolment, one-year follow-up will be carried out for each participant. Measurements will be performed at baseline, 3, 6 and 12 months (T0, T1, T2 and T3) for the intervention and control groups.

• 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.

  After enrolment, one-year follow-up will be carried out for each participant. Measurements will be performed at baseline, 3, 6 and 12 months (T0, T1, T2 and T3) for the intervention and control groups.

• Mental health - Self-report questionnaire

  A self-report questionnaire, which will include measures on demographic, psychiatric, and quality of life variables.

  After enrolment, one-year follow-up will be carried out for each participant. Measurements will be performed at baseline and 12 months (T0 and T3) for the intervention and control groups.

Secondary Outcomes (2)

• The lived experience of the participants

  3 months (T1) after enrolment, semi-structured interviews will be carried out for both arms (control and intervention) of participants

• The lived experience of the implicated clinicians

  6 months after the beginning of the study, semi-structured interviews will be carried out for implicated clinicians

Other Outcomes (3)

• Healthcare system complexity - Quantitative assessment

  Measurements will be performed at baseline, 3, 6 and 12 months (T0, T1 and T3).

• Healthcare system complexity - qualitative assessment

  3 months (T1) after the study inclusion for the participants and 6 months after the beginning of the study (T2) for the implicated clinicians.

• Access to mental healthcare

  Measurements will be performed at baseline, 3, 6 and 12 months (T0, T1 and T3).

Study Arms (2)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

Treatment as usual (TAU) conducted by PCP; the CL psychiatrist will not be involved in participants' treatment.

Other: Control Arm - Treatment As Usual (TAU)

Consultation-Liaison (CL) brief psychiatric intervention

EXPERIMENTAL

CL brief psychiatric intervention (2 months) will be conducted in primary care settings. CL psychiatrists will benefit from regular supervision by experienced CL psychiatrists.

Other: Intervention arm - Consultation-Liaison (CL) brief psychiatric intervention in primary care settings

Interventions

Intervention arm - Consultation-Liaison (CL) brief psychiatric intervention in primary care settings OTHER

The 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.

Consultation-Liaison (CL) brief psychiatric intervention

Control Arm - Treatment As Usual (TAU) OTHER

PCPs 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 As Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: lead
• Neuchâtel Psychiatry Centre (CNP): collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (3)

Centre Neuchâtelois de Psychiatrie (CNP)

Neuchâtel, Canton of Neuchâtel, 2000, Switzerland

RECRUITING

Center for Primary Care and Public Health (Unisanté) - Sponsorship / Not recruiting site

Lausanne, Canton of Vaud, 1010, Switzerland

ACTIVE NOT RECRUITING

Service de psychiatrie de l'adulte nord ouest (SPANO) Département de psychiatrie - CHUV (DP-CHUV)

Yverdon-les-Bains, Canton of Vaud, 1400, Switzerland

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychophysiologic Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Central Study Contacts

Konstantinos Tzartzas, MD

CONTACT

0041 21 314 61 10; konstantinos.tzartzas@unisante.ch

Stéphane Saillant, PD

CONTACT

0041 32 755 15 15; stephane.saillant@cnp.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)