SomPsyNet – Prevention of Psychosocial Distress Consequences in Somatic Medicine: a Model for Collaborative Care

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2022

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

  • Other: Implementation 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.

Arms, Groups and Cohorts

  • No Intervention: Treatment as usual
    • 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.
  • Experimental: Intervention condition
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in health related quality of life
    • Time Frame: 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 Measures

  • Change in Depression
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 health related quality of life
    • Time Frame: Baseline to 6 months follow-up
    • Health-related quality of life assessed by the Physical Health Component Summary score of the SF-36
  • Health economics
    • Time Frame: 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
    • Time Frame: 6 months follow-up
    • Resilience assessed by the Resilience Scale for Adults (RSA)
  • Social support
    • Time Frame: 6 months follow-up
    • Social support assessed by the Oslo social support scale (OSSS-3)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Collaborator
    • Gesundheitsförderung Schweiz, GFCH
  • Provider of Information About this Clinical Study
    • Sponsor
  • 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, rainer.schaefert@usb.ch

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