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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCenter for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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.

  • Control Arm - Treatment As Usual (TAU)

    Other intervention

    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 groups

30 Participants
are divided into 2 treatment groups
Group A: Treatment As Usual (TAU)Active comparator 1 intervention
Group B: Consultation-Liaison (CL) brief psychiatric interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 20 months
2

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.

Time frame
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.
3

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.

Time frame
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.
4

Mental health - Self-report questionnaire

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

Time frame
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

1

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.

Time frame
3 months (T1) after enrolment, semi-structured interviews will be carried out for both arms (control and intervention) of participants
2

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.

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

Other outcomes

1

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).

Time frame
Measurements will be performed at baseline, 3, 6 and 12 months (T0, T1 and T3).
2

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.

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

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).

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

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