Clinical trial NCT04745507: Implementation, Efficacy and Costs of Inpatient Equivalent Home-Treatment in German Mental Health Care
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Disorder
Personality Disorders
Schizo Affective Disorder
Anxiety Disorders
Eating Disorders
Addiction
Keywords: community mental health care
inpatient-equivalent home treatment
crisis resolution teams
Lead sponsor: Vivantes Netzwerk für Gesundheit GmbH
Sponsor class: OTHER
Collaborators: name: Medizinische Hochschule Brandenburg Theodor Fontane
name: Zentrum für Psychiatrie Südwürttemberg
name: Isar-Amper Klinikum München Ost
name: Klinik für Psychiatrie und Psychotherapie II der Universität Ulm
name: Kompetenzzentrum für Klinische Studien, Bremen
name: Vivantes Klinikum am Urban
First posted: 2021-02-09
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

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

Primary outcomes:
measure: Differences and change in the hospital re-admission rate
timeFrame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
Secondary outcomes:
measure: Combined readmission (day clinic, IEHT or hospital)
timeFrame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
measure: Continuity of care
timeFrame: [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]
measure: Total number of inpatient days
timeFrame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
measure: Generic health status
timeFrame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
measure: Psychosocial functioning
timeFrame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
measure: Personal and Social functioning
timeFrame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
measure: Professional reintegration
timeFrame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
measure: Personal Recovery
timeFrame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
measure: Cost-utility
timeFrame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
measure: Quality-adjusted life year
timeFrame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1
measure: Treatment satisfaction
timeFrame: (T0.2) 7 days before or after discharge
measure: Treatment satisfaction of close relatives or informal caregiver
timeFrame: (T0.2) 7 days before or after discharge
measure: Burden of close relatives or informal caregiver
timeFrame: (T0.2) 7 days before or after discharge
Other outcomes:
Locations:
city: Reichenau
country: Germany
facility: Zentrum für Psychiatrie Reichenau
state: Baden-Württemberg
city: Reutlingen
country: Germany
facility: PP.rt, Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbH,
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Klinik für Psychiatrie und Psychotherapie
state: Baden-Württemberg
city: Weißenau
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie I der Universität Ulm (Weissenau),
state: Baden-Württemberg
city: Zwiefalten
country: Germany
facility: • Zentrum für Psychiatrie Südwürttemberg, Klinik für Psychiatrie und Psychotherapie Zwiefalten
state: Baden-Württemberg
city: Haar
country: Germany
facility: kbo-Isar-Amper-Klinikum München-Ost
state: Bayern
city: Berlin-Kreuzberg
country: Germany
facility: Vivantes Klinikum am Urban; Klinik für Psychiatrie, Psychotherapie und Psychosomatik
state: Berlin
city: Berlin-Mitte
country: Germany
facility: • Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte,
state: Berlin
city: Rüdersdorf
country: Germany
facility: Immanuel Klinik Rüdersdorf, Abteilung für Psychiatrie, Psychotherapie und Psychosomatik, Psychiatrische Hochschulklinik
state: Brandenburg
city: Berlin
country: Germany
facility: Vivantes Neukölln, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
Study officials:
affiliation: Immanuel Klinik Rüdersdorf
name: Sebastian von Peter, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Vivantes Klinikum am Urban
name: Andreas Bechdolf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1055/s-2001-17790. German.
citation: 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. doi: 10.1159/000098492. Epub 2007 Jan 11.
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.
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. doi: 10.1055/s-2001-17792. German.
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.
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.