AzTrials
AzTrials

Mental DisorderAKtiVNCT04745507

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

An observational study of Mental Disorder and Personality Disorders, run by Vivantes Netzwerk für Gesundheit GmbH at 10 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Inpatient Equivalent Home Treatment
How many people
629 participants
Where
10 sitesGermany
Study dates
1 Jan 2021to 30 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Vivantes Neukölln, Klinik für Psychiatrie, Psychotherapie und Psychosomatik

    Berlin, 12351

  • kbo-Isar-Amper-Klinikum München-Ost

    Haar, Bavaria, 85540

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

    Kreuzberg, State of Berlin, 10967

  • • Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte,

    Mitte, State of Berlin, 10117

  • Zentrum für Psychiatrie Reichenau

    Reichenau, Baden-Wurttemberg, 78479

  • PP.rt, Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbH,

    Reutlingen, Baden-Wurttemberg, 72764

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

    Rüdersdorf, Brandenburg, 15562

  • Universitätsklinikum Tübingen, Klinik für Psychiatrie und Psychotherapie

    Tübingen, Baden-Wurttemberg, 72076

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

    Weißenau, Baden-Wurttemberg, 88214

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

    Zwiefalten, Baden-Wurttemberg, 88529

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Inpatient Equivalent Home Treatment
Keywords
community mental health care, inpatient-equivalent home treatment, crisis resolution teams
Medical subject headings
Mental Disorders, Personality Disorders, Psychotic Disorders, Anxiety Disorders, Feeding and Eating Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inpatient Equivalent Home TreatmentOther

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

Study groups in NCT04745507
Study groupRoleWhat they receive
Arm 1 / C1This cohort (C1) consists of 180 patients who receive IEHT in the recruiting sites, fulfil inclusion criteria and gave informed consent regarding their study participation.
Receives: Other: Inpatient Equivalent Home Treatment
Arm 2 / C2This 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 3360 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: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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1

Secondary outcomes (13)

  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).

    Measured: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1

  2. 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).

    Measured: [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]

  3. 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).

    Measured: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1

  4. 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).

    Measured: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1

  5. 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.

    Measured: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1

  6. 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.

    Measured: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1

  7. 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).

    Measured: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1

  8. 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.

    Measured: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1

  9. 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).

    Measured: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1

  10. 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)

    Measured: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1

  11. 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.

    Measured: (T0.2) 7 days before or after discharge

  12. 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.

    Measured: (T0.2) 7 days before or after discharge

  13. 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.

    Measured: (T0.2) 7 days before or after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2021
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
629 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04745507
Sponsor's protocol ID
01VSF19048
Acronym
AKtiV
Status last verified
Mar 2022
First submitted
7 Jan 2021
Last updated
16 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 11605129

  • 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.

    PubMed 17215598

  • 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.

    PubMed 28049083

  • 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.

    PubMed 11605131

  • 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.

    PubMed 28219389

  • 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.

    PubMed 21174069

  • Bechdolf A, Nikolaidis K, von Peter S, Langle G, Brieger P, Timm J, Killian R, Fischer L, Raschmann S, Schwarz J, Holzke M, Rout S, Hirschmeier C, Hamann J, Herwig U, Richter J, Baumgardt J, Weinmann S. Utilization of Psychiatric Hospital Services Following Intensive Home Treatment: A Nonrandomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2445042. doi: 10.1001/jamanetworkopen.2024.45042.

    PubMed 39546314

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Disorder and Personality Disorders, run by Vivantes Netzwerk für Gesundheit GmbH at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences and change in the hospital re-admission rate (time frame: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04745507, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in