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Evaluation of Home Treatment for Acute Psychiatric Care

Primary Purpose

Mental Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Home Treatment
Treatment-as-usual
Sponsored by
Psychiatric University Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Need for acute psychiatric inpatient care
  • Residence in Zurich city
  • Health insurance for Home Treatment

Exclusion Criteria:

  • none

Sites / Locations

  • Psychiatric University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home Treatment

Treatment-as-usual

Arm Description

Patients with acute mental illness are treated at their houses by a mobile and multiprofessional care team instead of being treated as inpatients if their medical condition permits.

Patients with acute mental illness are treated as inpatients in a psychiatric clinic.

Outcomes

Primary Outcome Measures

Inpatient days
Number of inpatient days per patient

Secondary Outcome Measures

Total days in treatment
Total days in Treatment per patient = inpatient and home treatment
Treatment costs
Calculated direct treatment costs
Rehospitalization rate
Number of rehospitalizations per patient and duration until rehospitalization
Adverse events
e.g. suicide or attempted suicide
Global Assessment of Functioning Scale (GAF)
Scale measures social, occupational and psychological functioning and ranges from 0 to 100 (higher values mean better outcome).
Health of the Nation Outcome Scale (HoNOS)
Scale measures the severity of symptoms and ranges from 0 to 48 (higher values mean worse outcome).
Clinical Global Impression Scale (CGI)
Scale measures the severity of symptoms, global improvement and therapeutic response and ranges from 0 to 7 (higher values mean worse outcome).
Patients' satisfaction
Patients' satisfaction assessed by the official questionnaire of the national association of the quality development in hospitals (ANQ)

Full Information

First Posted
October 19, 2017
Last Updated
October 24, 2017
Sponsor
Psychiatric University Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03320720
Brief Title
Evaluation of Home Treatment for Acute Psychiatric Care
Official Title
Evaluation of Home Treatment for Acute Psychiatric Care of the Psychiatric University Hospital Zurich (Switzerland)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psychiatric University Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Patients who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual), during one year. Following two years, the two treatment modalities will be analyzed in terms of inpatient days, cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics.
Detailed Description
The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Therefore, psychiatric patients in need of hospitalization who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual) during one year. Home treatment patients are visited by a mobile and multiprofessional care team at their homes. Additionally, patients without a health insurance for home treatment and patients who are directly assigned to home treatment are included in separate study groups. Following two years, it will be checked whether home treatment leads to a reduction of inpatient days as a primary outcome. Further outcomes such as cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics will be also analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home Treatment
Arm Type
Experimental
Arm Description
Patients with acute mental illness are treated at their houses by a mobile and multiprofessional care team instead of being treated as inpatients if their medical condition permits.
Arm Title
Treatment-as-usual
Arm Type
Active Comparator
Arm Description
Patients with acute mental illness are treated as inpatients in a psychiatric clinic.
Intervention Type
Other
Intervention Name(s)
Home Treatment
Intervention Description
Patients with acute mental illness in need of inpatient care are treated at their houses by a mobile and multiprofessional care team if their health condition permits.
Intervention Type
Other
Intervention Name(s)
Treatment-as-usual
Intervention Description
Patients with acute mental illness in need of inpatient care are treated in a psychiatric clinic.
Primary Outcome Measure Information:
Title
Inpatient days
Description
Number of inpatient days per patient
Time Frame
2 years follow-up
Secondary Outcome Measure Information:
Title
Total days in treatment
Description
Total days in Treatment per patient = inpatient and home treatment
Time Frame
2 years follow-up
Title
Treatment costs
Description
Calculated direct treatment costs
Time Frame
2 years follow-up
Title
Rehospitalization rate
Description
Number of rehospitalizations per patient and duration until rehospitalization
Time Frame
2 years follow-up
Title
Adverse events
Description
e.g. suicide or attempted suicide
Time Frame
2 years follow-up
Title
Global Assessment of Functioning Scale (GAF)
Description
Scale measures social, occupational and psychological functioning and ranges from 0 to 100 (higher values mean better outcome).
Time Frame
2 years follow-up
Title
Health of the Nation Outcome Scale (HoNOS)
Description
Scale measures the severity of symptoms and ranges from 0 to 48 (higher values mean worse outcome).
Time Frame
2 years follow-up
Title
Clinical Global Impression Scale (CGI)
Description
Scale measures the severity of symptoms, global improvement and therapeutic response and ranges from 0 to 7 (higher values mean worse outcome).
Time Frame
2 years follow-up
Title
Patients' satisfaction
Description
Patients' satisfaction assessed by the official questionnaire of the national association of the quality development in hospitals (ANQ)
Time Frame
2 years follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Need for acute psychiatric inpatient care Residence in Zurich city Health insurance for Home Treatment Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Jäger, MD
Phone
0041 44 384 26 37
Email
matthias.jaeger@puk.zh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Sonja Mötteli, PhD
Phone
0041 44 384 34 41
Email
sonja.moetteli@puk.zh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Jäger, MD
Organizational Affiliation
Psychiatric University Hospital, Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric University Hospital Zurich
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Jäger, MD
Phone
0041 44 384 26 37
Email
matthias.jaeger@puk.zh.ch
First Name & Middle Initial & Last Name & Degree
PhD
Phone
0041 44 384 34 41
Email
matthias.jaeger@puk.zh.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Home Treatment for Acute Psychiatric Care

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