Outreach Crisis Intervention With a Team-based and Integrative Model of Treatment (AKtiV Study): Evaluation of the Inpatient Equivalent HomeTreatment (IEHT According to the German Social Code Book §115d SGB V) - a Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 入组人数
- 629
- 试验地点
- 10
- 主要终点
- Differences and change in the hospital re-admission rate
研究概览
简要总结
The "inpatient-equivalent home treatment"(IEHT) according to §115d SGB-V is a particular version of the internationally well-known and evidence-based Home Treatment. As a complex intervention, IEHT requires a multi-method evaluation on different levels in the German context. The AKtiV study that is financed by the Innovation Fund of the Federal Joint Committee (proposal ID: VSF2_2019-108) meets this request. In this quasi-experimental study with a propensity score-matched control group, we assess and combine quantitative and qualitative data. Outcome parameters include classical clinical ones such as hospital readmission rates, mental state, and recovery outcomes. In addition, it evaluates issues concerning the right target population, treatment processes, implementation strategies, and factors associated with positive outcomes. The study takes into account the perspective of patients, relatives, staff as well as decision makers in politics and administration. Therefore, we expect the results to be relevant for a broad audience and to contribute to further refinement and adaption of the model.
详细描述
The overarching goal of the AKtiV trial is to examine implementation processes, treatment processes, clinical efficacy, costs, and subjective experiences of IEHT following §115d of the German Social Code Book Five (SGB-V)compared to inpatient treatment from the perspective of service users, relatives or rather informal care givers' , staff and other stakeholders in mental health care. To maximize transferability of study results and to cover a broad spectrum of IEHT experience, 10 hospitals from different regions of Germany (e.g. rural, urban, east, west) participate in this study. Combining routine data, primary data and prospective follow-up data, the study results will be based/ involve a comprehensive database. Further, the combination of clinical and health economic data will enable the assessment of costs and benefits from a national perspective, a particularity of importance, given that there are only a few studies with health economic evidence of acute outreach mental health care. The qualitative evaluation of processes and out-comes of IEHT uses a collaborative-participatory approach that aligns with current demands for more user orientation and/ or involvement of people and researchers with lived experience in the process of developing interventions and their evaluation. The mixed-methods design of the trial corresponds with current standards of empirical social research enabling the triangulation of hypothesis-confirming, quantifiable factors and hypothesis-generating, qualitative aspects. By parallelizing on one hand quantitative and qualitative data and on the other hand routine data with primary data, data on implementation processes and data on treatment processes, different facets from different perspectives and levels of IEHT are targeted. This allows for a comprehensive, holistic assessment of this innovative treatment offer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Differences and change in the hospital re-admission rate
时间窗: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
Observed Differences and change in the hospital re-admission of service users (C1 and C2) within 12 months after inclusion into the trial assessed via routine data of the study sites and the German Version oft the Client Sociodemographic and Service Receipt Inventory (CSSR-D; Roick et al., 2001).
次要结局
- Combined readmission (day clinic, IEHT or hospital)((T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1)
- Continuity of care([Time Frame: (T0.1) within 7 days after admission, (T0.2) 7 days before or after discharge , (T1) 6 months after T0.1, (T2) 12 months after T0.1])
- Total number of inpatient days((T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1)
- Generic health status((T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1)
- Psychosocial functioning((T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1)
- Personal and Social functioning((T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1)
- Professional reintegration((T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1)
- Personal Recovery((T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1)
- Cost-utility((T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1)
- Quality-adjusted life year((T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1)
- Treatment satisfaction((T0.2) 7 days before or after discharge)
- Treatment satisfaction of close relatives or informal caregiver((T0.2) 7 days before or after discharge)
- Burden of close relatives or informal caregiver((T0.2) 7 days before or after discharge)
研究者
Sebastian von Peter
Prof. Dr. med. Sebastian von Peter
Medizinische Hochschule Brandenburg Theodor Fontane