NCT04745507

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
629

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

January 7, 2021

Last Update Submit

March 1, 2022

Conditions

Mental DisorderPersonality DisordersSchizo Affective DisorderAnxiety DisordersEating DisordersAddiction

Keywords

community mental health careinpatient-equivalent home treatmentcrisis resolution teams

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (13)

  • Combined readmission (day clinic, IEHT or hospital)

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

  • Continuity of care

    [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]

  • Total number of inpatient days

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

  • Generic health status

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

  • Psychosocial functioning

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

  • +8 more secondary outcomes

Study Arms (4)

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.

Other: Inpatient Equivalent Home Treatment

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

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).

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).

Interventions

Inpatient Equivalent Home TreatmentOTHER

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

Arm 1 / C1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Zentrum für Psychiatrie Reichenau

Reichenau, Baden-Wurttemberg, 78479, Germany

Location

PP.rt, Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbH,

Reutlingen, Baden-Wurttemberg, 72764, Germany

Location

Universitätsklinikum Tübingen, Klinik für Psychiatrie und Psychotherapie

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

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

Weißenau, Baden-Wurttemberg, 88214, Germany

Location

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

Zwiefalten, Baden-Wurttemberg, 88529, Germany

Location

kbo-Isar-Amper-Klinikum München-Ost

Haar, Bavaria, 85540, Germany

Location

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

Rüdersdorf, Brandenburg, 15562, Germany

Location

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

Kreuzberg, State of Berlin, 10967, Germany

Location

• Klinik für Psychiatrie und Psychotherapie, Campus Charité Mitte,

Mitte, State of Berlin, 10117, Germany

Location

Vivantes Neukölln, Klinik für Psychiatrie, Psychotherapie und Psychosomatik

Berlin, 12351, Germany

Location

Related Publications (7)

  • 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.

    PMID: 11605129BACKGROUND

  • 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.

    PMID: 17215598BACKGROUND

  • 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.

    PMID: 28049083BACKGROUND

  • 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.

    PMID: 11605131BACKGROUND

  • 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.

    PMID: 28219389BACKGROUND

  • 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.

    PMID: 21174069BACKGROUND

  • 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.

    PMID: 39546314DERIVED

MeSH Terms

Conditions

Mental DisordersPersonality DisordersPsychotic DisordersAnxiety DisordersFeeding and Eating DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Sebastian von Peter, Prof. Dr.

    Immanuel Klinik Rüdersdorf

    STUDY DIRECTOR

  • Andreas Bechdolf, Prof. Dr.

    Vivantes Klinikum am Urban

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Sebastian von Peter

Study Record Dates

First Submitted

January 7, 2021

First Posted

February 9, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations

DE(10)