SomPsyNet - Prevention of Psychosocial Distress Consequences in Somatic Medicine: a Model for Collaborative Care

Study Overview
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Brief Summary
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This study is to evaluate the impact of the stepped and collaborative care model (SCCM) on health-related quality of life in somatic hospital patients with psychosocial distress.

Detailed Description
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Given the burden of psychosocial distress, the public health relevance, and the current standard of health care, new approaches to a model of care for patients with mental-somatic multimorbidity are urgently needed. SomPsyNet is a comprehensive healthcare project for patients from somatic hospitals that promotes the prevention of psychosocial distress by establishing a stepped and collaborative care network in Basel-Stadt, Switzerland and may therefore help to counteract against the described lack of care. SomPsyNet is a stepped and collaborative care model (SCCM) including a Psychosomatic-psychiatric consultation and liaison Service (CL Service) and post hospital intervention supported by a collaborative network structure. It aims to identify patients with psychosocial distress at an early stage during their hospital stay in a standardized way. Implementation of the SCCM within this study using the stepped-wedge cluster randomized trial (SW-CRT) design will take place in phases: SomPsyNet phase 0: treatment as usual (TAU) in combination with the baseline and follow-up survey in a distressed focus sample. SomPsyNet phase 1: TAU in combination with the baseline survey, implementation of screening questions stage 1 ('baseline distress information from professionals', without consequence) in hospital routine and follow-up survey in a distressed focus sample. SomPsyNet phase 2 refers to the implementation of the SCCM: baseline survey, assessment of screening questions stage 1 (with consequence), screening questions stage 2 (with consequence) and if necessary psychosomatic-psychiatric consultation and liaison service including if applicable post hospital intervention and a follow-up survey in a distressed focus sample.

Official Title
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SomPsyNet - Prevention of Psychosocial Distress Consequences in Somatic Medicine: a Model for Collaborative Care

Conditions
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Psychosocial Distress

Intervention / Treatment
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* Other: Implementation of the SCCM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients from selected wards (i. e., somatic diseases treated at these wards from three somatic hospitals) Exclusion Criteria: Inability to understand and speak German or any other language at which study is tailored at that point in time Inability to give informed consent by himself / herself Inability to follow the procedures of the study, e.g. due to severe medical / clinical limitations Need for immediate support as indicated by the risk of current suicidality or attempted suicide Oncological condition Already participated in the SomPsyNet project on the occasion of a previous hospitalization Confirmed current COVID-19 disease at time of screening for exclusion criteria Being hospitalized under the medical supervision of services of a ward that is not part of one of the SomPsyNet study clusters ('original ward'), but physically located in rooms of a ward contributing to one of the study clusters only because of lack of space in the original ward

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br>phase 0: Treatment as usual in combination with baseline and follow-up Survey but without any screening procedures (facilitating the study as a run-in phase to establish study procedures). phase 1: randomized and main control condition with TAU + collection of information on psychosocial distress in the baseline Intervention effects will be estimated, using the distressed focus sample, contrasting Phase 2 vs. Phase 1. We intend to conduct additional statistical analyses to compare data from phases 2 and 1 vs. phase 0 to estimate potential effects of introducing parts of the screening 1 without consequences. | |
| Experimental: Intervention condition<br>phase 2: implementation of the SCCM The intervention (SSCM) will be implemented step-wise in predefined sections at all three sites using a stepped-wedge cluster randomized trial design. Clusters will be randomized to different sequences that dictate the timing at which each cluster will switch from the control to the intervention condition. | Other: Implementation of the SCCM<br>* Implementation of the SCCM includes a baseline survey, assessment of screening questions stage 1 (with consequence), screening questions stage 2 (with consequence) and if necessary psychosomatic-psychiatric consultation and liaison service including if applicable post hospital intervention and a follow-up survey in a distressed focus sample.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health related quality of life | Health related quality of life will be assessed with the 'Mental Health Component Summary score' of the Short Form-36 (SF-36). The SF-36 consists of 36-Items to measure health-related quality of life using eight concepts (physical functioning (PF, 10 items), physical role functioning (RP, 4 items), bodily pain (BP, 2 items), general health perception (GH, 5 items), vitality (VT, 4 items), social role functioning (SF, 2 items), emotional role functioning (RE, 3 items) and mental health (MH, 5 items) to measure the 'Mental Health Component Summary score' | Baseline to 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression | Current depressive disorders assessed by the eight-item Patient Health Questionnaire depression scale (PHQ-8) | Baseline to 6 months follow-up | 
| Change in Generalized Anxiety Disorder | Generalized Anxiety Disorder assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7) | Baseline to 6 months follow-up | 
| Change in Somatic symptom disorder | Psychological features of Somatic Symptom Disorder (SSD) assessed by the 12-item Somatic Symptom Disorder Scale (SSD-12) | Baseline to 6 months follow-up | 
| Change in Somatic symptom burden | Somatic symptom severity assessed by the 8-item Somatic Symptom Scale-8 (SSS-8) | Baseline to 6 months follow-up | 
| Change in Quality of life | Health-related quality of life assessed by the 5-level EuroQol 5-dimensional questionnaire (EQ-5D- 5L) | Baseline to 6 months follow-up | 
| Change in health related quality of life | Health-related quality of life assessed by the Physical Health Component Summary score of the SF-36 | Baseline to 6 months follow-up | 
| Health economics | total costs of hospital treatment including additional medical, psychiatric or physiotherapeutic treatment during patient's hospital stay; follow-up costs at treating hospitals; healthcare costs, relevant sub-categories of costs and medical resource use based on health insurance claims data; indirect costs due to reduced productivity | 6 months to 3 years following initiation of the SCCM in a given patient | 
| Resilience | Resilience assessed by the Resilience Scale for Adults (RSA) | 6 months follow-up | 
| Social support | Social support assessed by the Oslo social support scale (OSSS-3) | 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, mental disorder, mental comorbidity, mental-somatic multimorbidity, stepped and collaborative care model (SCCM)