A Pilot Study on the Impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French Speaking Switzerland (PLIMeC-P): A Mixed Method Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Mental health - Self-report questionnaire
研究概览
简要总结
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.
详细描述
- BACKGROUND AND RATIONALE
According to the WHO, mental health is a central component of personal health and well-being. Mental disorders claim a heavy toll on individuals, their families and society, and are a major public health issue. In Switzerland, 18-21% of the population suffers from psychological distress, of which 12.7% have been diagnosed with a psychiatric disorder. Primary care physicians (PCP) are usually the first contact with healthcare for patients suffering from psychological distress or mental disorders. More precisely, a prevalence of 25-60% is reported for mental disorders in primary care, and this is the case worldwide, as well as in Switzerland. More than half of those patients have no specialized psychiatric care and PCPs tend to base their treatment on pharmacotherapy, support therapy, and psycho-education. PCPs are therefore key stakeholders in the detection, prevention, and adjusted treatment management of mental disorders.
Therefore, the optimization of both the quality of primary care interventions and cooperation with psychiatric care networks are important challenges. Patients with mental disorders are often considered complex patients and tend to be frequent care users, PCPs feeling lacking competency in dealing with them. Close collaboration between psychiatrists and PCPs, and multidisciplinary interventions can reinforce PCPs' skills and help them gain confidence in managing mental disorders. A wide range of collaboration models between psychiatrists and PCP exist, the Consultation Liaison (CL) interventions being one of them. However various barriers are described regarding such a collaboration, notably because of different treatment paradigms and of lack of accessibility.
In Switzerland, CL-psychiatric interventions are mainly used in hospital settings. To introduce a model of care that offers optimal management of mental disorders in primary care, ensuring an adequate continuity and good coordination of care, for patients with complex needs, a multidisciplinary collaboration project between PCP and CL-psychiatrists has been developed in a region of French-speaking Switzerland. A CL-psychiatric consultation within primary care practices has been implemented, to promote the quality of mental health care and facilitate communication between healthcare professionals. The need for further research on the implementation of psychiatric interventions in primary care is clearly highlighted. Moreover, the experience of patients, of PCPs and of psychiatrists during such interventions is rarely investigated, whereas emotional experiences seem to present one of the central obstacles to the optimal management of mental disorders in primary care.
Our study will investigate the impact of a CL-psychiatric intervention for patients with mental health problems in private primary care group practices, in French-speaking Switzerland, using mixed methods (qualitative and quantitative). In parallel, the lived experience of PCPs and CL-psychiatrists will be investigated during their collaboration, in order to better understand the factors that influence this type of intervention and to better qualify its results. Initially, a pilot study (PLIMeC-P) of the multi-center, multi-method PLIMeC study will be conducted, to determine whether the PLIMeC study is feasible. 2. STUDY OBJECTIVES AND DESIGN
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mental health - Self-report questionnaire
时间窗: 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.
A self-report questionnaire, which will include measures on demographic, psychiatric, and quality of life variables.
Evaluate the feasibility of the main PLIMeC study
时间窗: Up to 20 months
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
时间窗: 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.
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
时间窗: 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.
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.
次要结局
- 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)
