Implementation, Efficacy and Costs of Inpatient Equivalent Home-Treatment in German Mental Health Care

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Mental Disorder, Personality Disorders, Schizo Affective Disorder, Anxiety Disorders, Eating Disorders, Addiction

Intervention / Treatment
-----------------
* Other: Inpatient Equivalent Home Treatment


Participation Criteria
=================
Eligibility 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 exclusion criteria o in case of children living in the same household, presence of child welfare risk acute suicidality or aggressiveness towards others requiring hospital admission Being under order of commitment participation in an interventional study during the recruitment presence of substantial cognitive deficits as indicated by severe organic brain disease diagnosis of intellectual impairment admission longer ago than 7 days For C3: Close relative or informal caregiver living in the same household of the participating patient Inclusion criteria: • informed consent regarding study participation For C4: IEHT staff member of participating study cite OR local or political stakeholder engaged with IEHT Inclusion criteria: • informed consent regarding study participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1 / C1<br>This cohort (C1) consists of 180 patients who receive IEHT in the recruiting sites, fulfil inclusion criteria and gave informed consent regarding their study participation. | Other: Inpatient Equivalent Home Treatment<br>* At-home psychiatric treatment by means of a multiprofessional clinic team (an equivalent to stationary psychiatric care).<br>|
| Arm 2 / C2<br>This cohort (C2) consist of 180 patients receiving standard inpatient care (TAU) from the IEHT delivering hospital who fulfil inclusion criteria, are identified through a propensity score (PS) function as optimal control user or rather a PS match and gave informed consent regarding their study participation | |
| Arm 3<br>360 close relatives or informal caregivers living in the same household of the participating patients who gave informed consent regarding their study participation. Thereby, one relative of each patients who is participating in the trial will be assessed (C1 = 180, C2 = 180). | |
| Arm 4:<br>Staff members of participating study cites as well as local and political stakeholders engaged with IEHT who gave informed consent (approximately n = 100 participants overall). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences and change in the hospital re-admission rate | 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). | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined readmission (day clinic, IEHT or hospital) | 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). | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | 
| Continuity of care | 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). | [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 | 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). | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | 
| Generic health status | 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). | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | 
| Psychosocial functioning | 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. | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | 
| Personal and Social functioning | 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. | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | 
| Professional reintegration | 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). | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | 
| Personal Recovery | 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. | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | 
| Cost-utility | 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). | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | 
| Quality-adjusted life year | 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) | (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1 | 
| Treatment satisfaction | 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. | (T0.2) 7 days before or after discharge | 
| Treatment satisfaction of close relatives or informal caregiver | 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. | (T0.2) 7 days before or after discharge | 
| Burden of close relatives or informal caregiver | 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. | (T0.2) 7 days before or after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
community mental health care, inpatient-equivalent home treatment, crisis resolution teams