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| Name | Class |
|---|---|
| Gesundheitsförderung Schweiz, GFCH | UNKNOWN |
| Bethesda Krankenhaus | OTHER |
| University Department of Geriatric Medicine FELIX PLATTER | OTHER |
| Gesundheitsdepartement Basel-Stadt |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual | No Intervention | 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. | |
| Intervention condition | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation of the SCCM | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunther Meinlschmidt, Prof. Dr. rer. nat. | Department of Psychosomatic Medicine, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäre Altersmedizin Felix Platter | Basel | 4002 | Switzerland | |||
| Department of Psychosomatics/ Division of Medicine; University Hospital of Basel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34253168 | Background | Aebi NJ, Caviezel S, Schaefert R, Meinlschmidt G, Schwenkglenks M, Fink G, Riedo L, Leyhe T, Wyss K; SomPsyNet Consortium. A qualitative study to investigate Swiss hospital personnel's perceived importance of and experiences with patient's mental-somatic multimorbidities. BMC Psychiatry. 2021 Jul 12;21(1):349. doi: 10.1186/s12888-021-03353-5. | |
| 35592378 |
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The datasets being held by the SomPsyNet project are not readily available. In the case of inquiries by third parties that wish to reuse data SomPsyNet data after an embargo period, the following procedure is planned. Researchers interested in the data may submit a project synopsis addressed to the publications committee of the SomPsyNet project and will have to obtain authorization from the responsible ethics committee as ordained in the Ordinance of 20 September 2013 on Human Research with the exception of Clinical Trials (Human Research Ordinance, HRO). The publication committee will review the project synopsis and will answer the formal requests of applicants.
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Only upon collection of all important consents and upon approval of the responsible ethics committee(s), the requested data will be transferred to the applicants. Third parties have to confirm and provide evidence to comply with all relevant Swiss and cantonal laws and regulations (especially regarding data protection and Human Research), as well as all obligations and regulations set out in the documents and contracts related to SomPsyNet. Fees may apply to cover expenses related to data reuse. Requests to access the datasets should be directed to Gunther Meinlschmidt, gunther.meinlschmidt@unibas.ch
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| UNKNOWN |
| Swiss Tropical & Public Health Institute | OTHER |
| Institute of Pharmaceutical Medicine (ECPM), University of Basel | UNKNOWN |
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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).
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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 |
| Basel |
| 4031 |
| Switzerland |
| Universitätsspital Basel - Frauenklinik | Basel | 4031 | Switzerland |
| Bethesda Spital AG | Basel | 4052 | Switzerland |
| Aebi NJ, Fink G, Wyss K, Schwenkglenks M, Baenteli I, Caviezel S, Studer A, Trost S, Tschudin S, Schaefert R, Meinlschmidt G; SomPsyNet Consortium. Association of Different Restriction Levels With COVID-19-Related Distress and Mental Health in Somatic Inpatients: A Secondary Analysis of Swiss General Hospital Data. Front Psychiatry. 2022 May 3;13:872116. doi: 10.3389/fpsyt.2022.872116. eCollection 2022. |
| 37996236 | Derived | Meinlschmidt G, Frick A, Baenteli I, Karpf C, Studer A, Bachmann M, Dorner A, Tschudin S, Trost S, Wyss K, Fink G, Schwenkglenks M, Caviezel S, Rocco T, Schaefert R; SomPsyNet consortium. Prevention of psychosocial distress consequences in somatic hospital inpatients via a stepped and collaborative care model: protocol of SomPsyNet, a stepped wedge cluster randomised trial. BMJ Open. 2023 Nov 23;13(11):e076814. doi: 10.1136/bmjopen-2023-076814. |