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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psychosocial Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

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).

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Implementation of the SCCM

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No