SomPsyNet - Prevention of Psychosocial Distress Consequences in Somatic Medicine: a Model for Collaborative Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,500
- 试验地点
- 8
- 主要终点
- Change in health related quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients from selected wards (i. e., somatic diseases treated at these wards from three somatic hospitals)
排除标准
- •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
结局指标
主要结局
Change in health related quality of life
时间窗: 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'
次要结局
- Change in Depression(Baseline to 6 months follow-up)
- Change in Generalized Anxiety Disorder(Baseline to 6 months follow-up)
- Change in Somatic symptom disorder(Baseline to 6 months follow-up)
- Change in Somatic symptom burden(Baseline to 6 months follow-up)
- Change in health related quality of life(Baseline to 6 months follow-up)
- Change in Quality of life(Baseline to 6 months follow-up)
- Health economics(6 months to 3 years following initiation of the SCCM in a given patient)
- Resilience(6 months follow-up)
- Social support(6 months follow-up)