The CoLiPri study is a cluster randomized controlled trial funded by the Swiss National Science Foundation to evaluate the clinical and cost effectiveness as well as the implementation of a complex consultation-liaison intervention to help improve symptoms of anxiety and depression of screened patients in primary care. The intervention includes expert consultations, on demand referral for structured mental health diagnostics, psychoeducation and treatment planning, as well as brief psychotherapeutic interventions and triage.
Mental disorders such as depression or anxiety are serious and common health conditions that are highly prevalent in primary care. The primary care sector plays a key role in the treatment of common mental disorders as general practitioners (GPs) set the course for identification, diagnosis, therapy and referral to specialized treatment. The objectives of the CoLiPri study are to implement a complex consultation-liaison service at the intersection between primary and secondary care and to investigate its clinical and cost effectiveness in patients who are identified at primary care practices with elevated symptoms of depression and anxiety. Focus of the complex intervention is on improved collaboration and communication among GPs, mental health experts, and other services involved in the care of patients with common mental disorders. The novel service aims to support the decision-process at primary care practices, to increase access to evidence-based mental health treatment, and to help improve patients' pathways of care. The CoLiPri service for GPs include expert consultations, on-demand patient referral for structured diagnostics, and/or treatment planning, as well as brief psychotherapeutic interventions and triage. The effectiveness and cost effectiveness of the intervention as an add-on to enhanced usual primary care (usual care plus structured depression and anxiety screening) are evaluated in a cluster randomized clinical trial in screened patients with at least mild symptoms of depression and/or anxiety. In case of positive results, the service might serve as a model how to improve multi professional collaboration and clinical resource allocation for better delivery of mental health care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
General practitioners and their screened patients have access to the consultation-liaison services for a total duration of 12 months, including standard screening, expert consultations, on demand patient referral for structured mental health diagnostics, psychoeducation and treatment planning, as well as brief psychotherapeutic intervention and triage.
Usual primary care practice as offered in routine care. Enhanced means that practitioners receive a basic training which consists of guideline-based structured screening procedures for depression and anxiety mental disorders in primary care.
University of Zurich
Zurich, Switzerland
Change in depressive and anxiety symptoms
Patient-reported depressive and anxiety symptoms will be assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) total score until 6-month follow-up. The PHQ-ADS combines the 9 items of the Depression Module of the PHQ (PHQ-9) and the 7 items of the General Anxiety Disorders 7 (GAD-7) to a single reliable and valid symptom measure. PHQ-ADS scores can range from 0 to 48 with higher scores indicating more severe depression/anxiety.
Time frame: Baseline, 3 months, 6 months
Clinical response in depressive and anxiety symptoms
Clinical response, defined as 50% reduction in patient-reported depressive and anxiety symptoms, will be assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) total score until 6-month follow-up.
Time frame: Baseline, 6 months
Change in depressive and anxiety symptoms until 12-month follow-up
Patient-reported depressive and anxiety symptoms will be assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) total score and subdomains, depression and anxiety, until 12-month follow-up.
Time frame: Baseline, 3 months, 6 months, 12 months
Health-related quality of life
Health-related quality of life (HrQoL) and health state based on patient self-report assessed with the Short Form Health Survey SF-12 total and physical and mental health subscales until 6 and 12 months follow-up.
Time frame: Baseline, 6 months, 12 months
Health care utilization
Patients' self-reported health care utilization will be measured with the Client Sociodemographic and Service Receipt Inventory-German Version (CSSRI-D) as a basis for health economic analyses.
Time frame: Baseline, 6 months, 12 months
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Masking
NONE
Enrollment
82
Utility-based health-related quality of life
Utility-based health-related Quality of Life will be assessed via patient self-report with the five-level version of EQ-5D (EQ-5D-5L).
Time frame: Baseline, 3 months, 6 months, 12 months
Cost-effectiveness
Cost-effectiveness evaluated with the information on healthcare utilization and productivity losses (direct and indirect costs) assessed with the CSSRI-D accumulated during 6 and 12 months. Quality-adjusted life years (QALYs) will be determined based on EQ-5D-5L based utility.
Time frame: Baseline, 6 months, 12 months