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

NCT ID: NCT04745507

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 629 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-06-30

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm 1 / C1

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.

Inpatient Equivalent Home Treatment

Intervention Type: OTHER

At-home psychiatric treatment by means of a multiprofessional clinic team (an equivalent to stationary psychiatric care).

Arm 2 / C2

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

No interventions assigned to this group

Arm 3

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).

No interventions assigned to this group

Arm 4:

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).

No interventions assigned to this group

Interventions

Inpatient Equivalent Home Treatment

At-home psychiatric treatment by means of a multiprofessional clinic team (an equivalent to stationary psychiatric care).

Intervention Type: OTHER

Eligibility Criteria

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

• informed consent regarding study participation

For C4: IEHT staff member of participating study cite OR local or political stakeholder engaged with IEHT

• informed consent regarding study participation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medizinische Hochschule Brandenburg Theodor Fontane

OTHER

Sponsor Role: collaborator

Zentrum für Psychiatrie Südwürttemberg

UNKNOWN

Sponsor Role: collaborator

Isar-Amper Klinikum München Ost

UNKNOWN

Sponsor Role: collaborator

Klinik für Psychiatrie und Psychotherapie II der Universität Ulm

UNKNOWN

Sponsor Role: collaborator

Kompetenzzentrum für Klinische Studien, Bremen

UNKNOWN

Sponsor Role: collaborator

Vivantes Klinikum am Urban

UNKNOWN

Sponsor Role: collaborator

Vivantes Netzwerk für Gesundheit GmbH

OTHER

Sponsor Role: lead

Responsible Party

Sebastian von Peter

Prof. Dr. med. Sebastian von Peter

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastian von Peter, Prof. Dr.

Role: STUDY_DIRECTOR

Immanuel Klinik Rüdersdorf

Andreas Bechdolf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Vivantes Klinikum am Urban

Locations

Zentrum für Psychiatrie Reichenau

Reichenau, Baden-Wurttemberg, Germany

PP.rt, Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbH,

Reutlingen, Baden-Wurttemberg, Germany

Universitätsklinikum Tübingen, Klinik für Psychiatrie und Psychotherapie

Tübingen, Baden-Wurttemberg, Germany

Klinik für Psychiatrie und Psychotherapie I der Universität Ulm (Weissenau),

Weißenau, Baden-Wurttemberg, Germany

• Zentrum für Psychiatrie Südwürttemberg, Klinik für Psychiatrie und Psychotherapie Zwiefalten

Zwiefalten, Baden-Wurttemberg, Germany

kbo-Isar-Amper-Klinikum München-Ost

Haar, Bavaria, Germany

Immanuel Klinik Rüdersdorf, Abteilung für Psychiatrie, Psychotherapie und Psychosomatik, Psychiatrische Hochschulklinik

Rüdersdorf, Brandenburg, Germany

Vivantes Klinikum am Urban; Klinik für Psychiatrie, Psychotherapie und Psychosomatik

Kreuzberg, State of Berlin, Germany

• Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte,

Mitte, State of Berlin, Germany

Vivantes Neukölln, Klinik für Psychiatrie, Psychotherapie und Psychosomatik

Berlin, , Germany

Countries

Germany

References

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Other Identifiers

01VSF19048

Identifier Type: -

Identifier Source: org_study_id