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

Vivantes Netzwerk für Gesundheit GmbH

Status: Unknown

Conditions: Mental Disorder; Eating Disorders; Schizo Affective Disorder; Addiction; Anxiety Disorders; Personality Disorders

Treatments: Other: Inpatient Equivalent Home Treatment

Study type: Observational

Funder types: Other

Identifiers

NCT04745507

01VSF19048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 629 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

629 participants in 4 patient groups

Arm 1 / C1

Description:

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.

Treatment:

Other: Inpatient Equivalent Home Treatment

Arm 2 / C2

Description:

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

Description:

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:

Description:

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).