Clinical trial NCT04269005: SomPsyNet - Prevention of Psychosocial Distress Consequences in Somatic Medicine: a Model for Collaborative Care
Official title: SomPsyNet - Prevention of Psychosocial Distress Consequences in Somatic Medicine: a Model for Collaborative Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychosocial Distress
Keywords: mental health
mental disorder
mental comorbidity
mental-somatic multimorbidity
"stepped and collaborative care model" (SCCM)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Gesundheitsförderung Schweiz, GFCH
name: Bethesda Krankenhaus
name: University Department of Geriatric Medicine FELIX PLATTER
name: Gesundheitsdepartement Basel-Stadt
name: Swiss Tropical & Public Health Institute
name: Institute of Pharmaceutical Medicine (ECPM), University of Basel
First posted: 2020-02-13
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in health related quality of life
timeFrame: Baseline to 6 months follow-up
Secondary outcomes:
measure: Change in Depression
timeFrame: Baseline to 6 months follow-up
measure: Change in Generalized Anxiety Disorder
timeFrame: Baseline to 6 months follow-up
measure: Change in Somatic symptom disorder
timeFrame: Baseline to 6 months follow-up
measure: Change in Somatic symptom burden
timeFrame: Baseline to 6 months follow-up
measure: Change in Quality of life
timeFrame: Baseline to 6 months follow-up
measure: Change in health related quality of life
timeFrame: Baseline to 6 months follow-up
measure: Health economics
timeFrame: 6 months to 3 years following initiation of the SCCM in a given patient
measure: Resilience
timeFrame: 6 months follow-up
measure: Social support
timeFrame: 6 months follow-up
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäre Altersmedizin Felix Platter
city: Basel
country: Switzerland
facility: Department of Psychosomatics/ Division of Medicine; University Hospital of Basel
city: Basel
country: Switzerland
facility: Universitätsspital Basel - Frauenklinik
city: Basel
country: Switzerland
facility: Bethesda Spital AG
Study officials:
affiliation: Department of Psychosomatic Medicine, University Hospital Basel
name: Gunther Meinlschmidt, Prof. Dr. rer. nat.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.