An observational study in Mental Disorder, Personality Disorders and Schizo Affective Disorder, sponsored by Vivantes Netzwerk für Gesundheit GmbH. Status unknown at 10 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Vivantes Netzwerk für Gesundheit GmbH · Observational
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.
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.
4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's enrollment of 629 is above the median of 150 across 606 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Vivantes Netzwerk für Gesundheit GmbH is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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C1: This cohort consists of patients who receive IEHT in the recruiting sites.
C2: This cohort consits of patients receiving standard inpatient care (treatment as usual / TAU) from the IEHT delivering hospital
C3: This cohort consits of close relatives or informal caregivers living in the same househod of the participating patients.
C4: Staff members of participatimg study cites as well as local and political stakeolders engaged with IEHT
For C1 and C2:
Inclusion criteria:
IEHT inclusion criteria
Exclusion criteria:
IEHT exclusion criteria
o in case of children living in the same household, presence of child welfare risk
For C3: Close relative or informal caregiver living in the same household of the participating patient
Inclusion criteria:
For C4: IEHT staff member of participating study cite OR local or political stakeholder engaged with IEHT
Inclusion criteria:
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
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
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).
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).
At-home psychiatric treatment by means of a multiprofessional clinic team (an equivalent to stationary psychiatric care).
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).
Time frame: (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)
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).
Time frame: (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: [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).
Time frame: (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).
Time frame: (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.
Time frame: (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.
Time frame: (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).
Time frame: (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.
Time frame: (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).
Time frame: (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)
Time frame: (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.
Time frame: (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.
Time frame: (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.
Time frame: (T0.2) 7 days before or after discharge
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Vivantes Netzwerk für Gesundheit GmbH