Psychosocial Distress
Conditions
Keywords
mental health, mental disorder, mental comorbidity, mental-somatic multimorbidity, stepped and collaborative care model (SCCM)
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.
Interventions
OTHERImplementation of the SCCM
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.
Sponsors
Gesundheitsförderung Schweiz, GFCH
Bethesda Krankenhaus
University Department of Geriatric Medicine FELIX PLATTER
Gesundheitsdepartement Basel-Stadt
Swiss Tropical & Public Health Institute
Institute of Pharmaceutical Medicine (ECPM), University of Basel
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Hospital employees who will assign patients to the wards and clusters are blinded to randomization. Blinding of staff involved in the recruitment process is limited as phase 1 and phase 2 will consist of different study information and consent sheets. Trained staff will perform the follow-up assessment, and we intend to blind them regarding study phase allocation of the patients (if procedural aspects allow it).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| Change in Depression | Baseline to 6 months follow-up | Current depressive disorders assessed by the eight-item Patient Health Questionnaire depression scale (PHQ-8) |
| 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) |
| 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 |
Countries
Switzerland
Outcome results
None listed