Addiction, Anxiety Disorders, Eating Disorders, Mental Disorder, Personality Disorders, Schizo Affective Disorder
Conditions
Keywords
community mental health care, inpatient-equivalent home treatment, crisis resolution teams
Brief summary
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.
Detailed description
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.
Interventions
OTHERInpatient Equivalent Home Treatment
At-home psychiatric treatment by means of a multiprofessional clinic team (an equivalent to stationary psychiatric care).
Sponsors
Medizinische Hochschule Brandenburg Theodor Fontane
Zentrum für Psychiatrie Südwürttemberg
Isar-Amper Klinikum München Ost
Klinik für Psychiatrie und Psychotherapie II der Universität Ulm
Kompetenzzentrum für Klinische Studien, Bremen
Vivantes Klinikum am Urban
Vivantes Netzwerk für Gesundheit GmbH
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For C1 and C2: Inclusion criteria: * IEHT inclusion criteria * acute mental health crisis that requires inpatient treatment; * social and living surrounding allowing for home visits and private conversations; * informed consent of all adults living in the service user's place of residency; * ability to provide informed consent * sufficient German language skills * permanent residence in the catchment area of the IEHT delivering Hospital * main diagnosis within the ICD codes F0X, F1X, F2X, F3X, F4X, F5X, or F6X
Exclusion criteria
* IEHT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences and change in the hospital re-admission rate | (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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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] | The amount of service users (C1 and C2) dropping out of treatment 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). |
| Total number of inpatient days | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | Total number of inpatient days of service users (C1 and C2) after inclusion into the trial assessed via routine data of the study sites and the German Version of the Client Sociodemographic and Service Receipt Inventory (CSSR-D; Roick et al., 2001). |
| Psychosocial functioning | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | The psychosocial functioning of service users (C1 and C2) after inclusion into the trial assessed via the German Version of the Health of the Nation Outcome Scales (HoNOS-D; Andreas S. et. al., 2007). * the unabbreviated scale title: Health of the Nation Outcome Scales * the minimum and maximum values: 0, 48 * higher scores mean a worse outcome. |
| Generic health status | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | Generic health status of service users (C1 and C2) after inclusion into the trial assessed via the German Version of the EQ-5D-5L (Ludwig, von der Schulenburg, & Greiner, 2017). |
| Personal and Social functioning | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | The level Personal and Social functioning of service users (C1 and C2) after inclusion into the trial assessed via the German Version of the Personal and Social Performance Scale (PSP; Schaub & Juckel, 2011). * the unabbreviated scale title: Deutsche Version der Personal and Social Performance Scale * the minimum and maximum values: 0, 100 * higher scores mean a better outcome. |
| Professional reintegration | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | The professional/work reintegration of service users (C1 and C2) after inclusion into the trial assessed via the German Version oft the Client Sociodemographic and Service Receipt Inventory (CSSR-D; Roick et al., 2001). |
| 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 | Combined readmission (day clinic, IEHT or hospital) 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). |
| Cost-utility | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | Cost-utility including direct and indirect disease related costs of service users (C1 and C2) after inclusion into the trial assessed via the German Version oft the Client Sociodemographic and Service Receipt Inventory (CSSR-D; Roick et al., 2001). |
| Quality-adjusted life year | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | Quality-adjusted life years of service users (C1 and C2) after inclusion into the trial assessed via the German Version of the EQ-5D-5L (Ludwig, von der Schulenburg, & Greiner, 2017) |
| Treatment satisfaction | (T0.2) 7 days before or after discharge | The treatment satisfaction of service users (C1 and C2) assessed by a self developed questionnaire. * the unabbreviated scale title: Behandlungszufriedenheit * the minimum and maximum values: 0, 72 * higher scores mean a better outcome. |
| Treatment satisfaction of close relatives or informal caregiver | (T0.2) 7 days before or after discharge | The treatment satisfaction of close relatives or informal caregiver (C3) for both groups (C1 and C2) assessed by a self developed questionnaire. * the unabbreviated scale title: Zufriedenheitsbefragung Angehörige * the minimum and maximum values: 0, 52 * higher scores mean a better outcome. |
| Burden of close relatives or informal caregiver | (T0.2) 7 days before or after discharge | Burden of close relatives or informal caregiver (C3) for both groups (C1 and C2) assessed by via the German Version of the Involvement Evaluation Questionnaire (IEQ-EU; Bernert, et. al, 2001). * the unabbreviated scale title: Involvement Evaluation Questionnaire * the minimum and maximum values: 0, 120 * higher scores mean a worse outcome. |
| Personal Recovery | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | Personal recovery of service users (C1 and C2) after inclusion into the trial assessed via the German Version of the Recovery Assessment Scale (RAS-G; Cavelti et. al, 2016). * the unabbreviated scale title: Recovery Assessment Scale-German Version * the minimum and maximum values: 14, 70 * higher scores mean a better outcome. |
Countries
Germany
Outcome results
None listed