SomPsyNet - Prevention of Psychosocial Distress Consequences in Somatic Medicine: a Model for Collaborative Care
- Conditions
- Psychosocial Distress
- Interventions
- Other: Implementation of the SCCM
- Registration Number
- NCT04269005
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2500
- patients from selected wards (i. e., somatic diseases treated at these wards from three somatic hospitals)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention condition Implementation of the SCCM 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.
- Primary Outcome Measures
Name Time Method Change in health related quality of life Baseline to 6 months follow-up 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'
- Secondary Outcome Measures
Name Time Method Change in Depression Baseline to 6 months follow-up Current depressive disorders assessed by the eight-item Patient Health Questionnaire depression scale (PHQ-8)
Change in Generalized Anxiety Disorder Baseline to 6 months follow-up Generalized Anxiety Disorder assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)
Change in Somatic symptom disorder Baseline to 6 months follow-up Psychological features of Somatic Symptom Disorder (SSD) assessed by the 12-item Somatic Symptom Disorder Scale (SSD-12)
Change in Somatic symptom burden Baseline to 6 months follow-up Somatic symptom severity assessed by the 8-item Somatic Symptom Scale-8 (SSS-8)
Change in health related quality of life Baseline to 6 months follow-up Health-related quality of life assessed by the Physical Health Component Summary score of the SF-36
Change in Quality of life Baseline to 6 months follow-up "Health-related quality of life assessed by the 5-level EuroQol 5-dimensional questionnaire (EQ-5D- 5L)"
Health economics 6 months to 3 years following initiation of the SCCM in a given patient 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
Resilience 6 months follow-up Resilience assessed by the Resilience Scale for Adults (RSA)
Social support 6 months follow-up Social support assessed by the Oslo social support scale (OSSS-3)
Trial Locations
- Locations (4)
Bethesda Spital AG
🇨🇭Basel, Switzerland
Department of Psychosomatics/ Division of Medicine; University Hospital of Basel
🇨🇭Basel, Switzerland
Universitätsspital Basel - Frauenklinik
🇨🇭Basel, Switzerland
Universitäre Altersmedizin Felix Platter
🇨🇭Basel, Switzerland