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.
Full Title of Study: “SomPsyNet – Prevention of Psychosocial Distress Consequences in Somatic Medicine: a Model for Collaborative Care”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Primary Purpose: Health Services Research
- Masking: Single (Care Provider)
- Study Primary Completion Date: August 2022
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.
- Other: Assessment of psychosocial distress in hospital routine process by the intaking physician on the respective ward
- In order to identify somatic patients with psychosocial distress, the estimation of psychosocial distress by hospital staff is required. Therefore one question is implemented in the hospital routine process to assess the patient’s psychosocial distress by the intaking physician on the respective ward
- Other: Assessment of psychosocial distress in hospital routine process by the nursing staff on the respective ward
- In order to identify somatic patients with psychosocial distress, the estimation of psychosocial distress by hospital staff is required. Therefore one question is implemented in the hospital routine process to assess the patient’s psychosocial distress by the nursing staff on the respective ward
Arms, Groups and Cohorts
- No Intervention: Phase 0: control condition with TAU
- without any screening procedures (and facilitating the study as a run-in phase to establish study procedures)
- Other: Phase 1:
- randomized and main control condition with TAU + collection of information on psychosocial distress in the baseline
Clinical Trial Outcome Measures
- change from baseline of the ‘Mental Health Component Summary score’ of the Short Form-36 (SF-36)
- Time Frame: at study entry (baseline) and at 6 months follow-up
- consists of 36-Items to assess 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 ‘Physical Health Component Summary score’ and the ‘Mental Health Component Summary score’
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Gesundheitsförderung Schweiz, GFCH
- Provider of Information About this Clinical Study
- Overall Official(s)
- Gunther Meinlschmidt, Prof. Dr. rer. nat., Principal Investigator, Department of Psychosomatic Medicine, University Hospital Basel
- Overall Contact(s)
- Rainer Schaefert, Prof. Dr. med, +41 61 265 52 94, email@example.com
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