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

Anxiety Disorders Clinical Trial

— AKtiV  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04745507
• Other study ID #: 01VSF19048
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2022
• Source: Vivantes Netzwerk für Gesundheit GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 629
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Anxiety Disorders
• Disease
• Eating Disorders
• Feeding and Eating Disorders
• Mental Disorder
• Mental Disorders
• Mood Disorders
• Personality Disorders
• Psychotic Disorders
• Schizo Affective Disorder

Intervention

Other:
• Inpatient Equivalent Home Treatment
At-home psychiatric treatment by means of a multiprofessional clinic team (an equivalent to stationary psychiatric care).

Locations

Country	Name	City	State
Germany	Vivantes Neukölln, Klinik für Psychiatrie, Psychotherapie und Psychosomatik	Berlin
Germany	Vivantes Klinikum am Urban; Klinik für Psychiatrie, Psychotherapie und Psychosomatik	Berlin-Kreuzberg	Berlin
Germany	• Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte,	Berlin-Mitte	Berlin
Germany	kbo-Isar-Amper-Klinikum München-Ost	Haar	Bayern
Germany	Zentrum für Psychiatrie Reichenau	Reichenau	Baden-Württemberg
Germany	PP.rt, Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbH,	Reutlingen	Baden-Württemberg
Germany	Immanuel Klinik Rüdersdorf, Abteilung für Psychiatrie, Psychotherapie und Psychosomatik, Psychiatrische Hochschulklinik	Rüdersdorf	Brandenburg
Germany	Universitätsklinikum Tübingen, Klinik für Psychiatrie und Psychotherapie	Tübingen	Baden-Württemberg
Germany	Klinik für Psychiatrie und Psychotherapie I der Universität Ulm (Weissenau),	Weißenau	Baden-Württemberg
Germany	• Zentrum für Psychiatrie Südwürttemberg, Klinik für Psychiatrie und Psychotherapie Zwiefalten	Zwiefalten	Baden-Württemberg

Sponsors (7)

Lead Sponsor	Collaborator
Vivantes Netzwerk für Gesundheit GmbH	Isar-Amper Klinikum München Ost, Klinik für Psychiatrie und Psychotherapie II der Universität Ulm, Kompetenzzentrum für Klinische Studien, Bremen, Medizinische Hochschule Brandenburg Theodor Fontane, Vivantes Klinikum am Urban, Zentrum für Psychiatrie Südwürttemberg

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Andreas S, Harfst T, Dirmaier J, Kawski S, Koch U, Schulz H. A Psychometric evaluation of the German version of the 'Health of the Nation Outcome Scales, HoNOS-D': on the feasibility and reliability of clinician-performed measurements of severity in patients with mental disorders. Psychopathology. 2007;40(2):116-25. Epub 2007 Jan 11. — View Citation

Bernert S, Kilian R, Matschinger H, Mory C, Roick C, Angermeyer MC. [The assessment of burden on relatives of mentally ill people: the German version of the involvement evaluation questionnaire (IEQ-EU)]. Psychiatr Prax. 2001 Oct;28 Suppl 2:S97-101. German. — View Citation

Cavelti M, Wirtz M, Corrigan P, Vauth R. Recovery assessment scale: Examining the factor structure of the German version (RAS-G) in people with schizophrenia spectrum disorders. Eur Psychiatry. 2017 Mar;41:60-67. doi: 10.1016/j.eurpsy.2016.10.006. Epub 2016 Dec 31. — View Citation

Ludwig K, von der Schulenburg JG, Greiner W. Valuation of the EQ-5D-5L with composite time trade-off for the German population - an exploratory study. Health Qual Life Outcomes. 2017 Feb 20;15(1):39. doi: 10.1186/s12955-017-0617-9. — View Citation

Roick C, Kilian R, Matschinger H, Bernert S, Mory C, Angermeyer MC. [German adaptation of the client sociodemographic and service receipt inventory - an instrument for the cost of mental health care]. Psychiatr Prax. 2001 Oct;28 Suppl 2:S84-90. German. — View Citation

Schaub D, Juckel G. [PSP Scale: German version of the Personal and Social Performance Scale: valid instrument for the assessment of psychosocial functioning in the treatment of schizophrenia]. Nervenarzt. 2011 Sep;82(9):1178-84. doi: 10.1007/s00115-010-3204-4. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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]
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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