- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03320720
Evaluation of Home Treatment for Acute Psychiatric Care
October 24, 2017 updated by: Matthias Jäger, Psychiatric University Hospital, Zurich
Evaluation of Home Treatment for Acute Psychiatric Care of the Psychiatric University Hospital Zurich (Switzerland)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
700
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zurich
-
Zürich, Zurich, Switzerland, 8032
- Psychiatric University Hospital Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Need for acute psychiatric inpatient care
- Residence in Zurich city
- Health insurance for Home Treatment
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home Treatment
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 in need of inpatient care are treated at their houses by a mobile and multiprofessional care team if their health condition permits.
|
|
Active Comparator: Treatment-as-usual
Patients with acute mental illness are treated as inpatients in a psychiatric clinic.
|
Patients with acute mental illness in need of inpatient care are treated in a psychiatric clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inpatient days
Time Frame: 2 years follow-up
|
Number of inpatient days per patient
|
2 years follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total days in treatment
Time Frame: 2 years follow-up
|
Total days in Treatment per patient = inpatient and home treatment
|
2 years follow-up
|
|
Treatment costs
Time Frame: 2 years follow-up
|
Calculated direct treatment costs
|
2 years follow-up
|
|
Rehospitalization rate
Time Frame: 2 years follow-up
|
Number of rehospitalizations per patient and duration until rehospitalization
|
2 years follow-up
|
|
Adverse events
Time Frame: 2 years follow-up
|
e.g.
suicide or attempted suicide
|
2 years follow-up
|
|
Global Assessment of Functioning Scale (GAF)
Time Frame: 2 years follow-up
|
Scale measures social, occupational and psychological functioning and ranges from 0 to 100 (higher values mean better outcome).
|
2 years follow-up
|
|
Health of the Nation Outcome Scale (HoNOS)
Time Frame: 2 years follow-up
|
Scale measures the severity of symptoms and ranges from 0 to 48 (higher values mean worse outcome).
|
2 years follow-up
|
|
Clinical Global Impression Scale (CGI)
Time Frame: 2 years follow-up
|
Scale measures the severity of symptoms, global improvement and therapeutic response and ranges from 0 to 7 (higher values mean worse outcome).
|
2 years follow-up
|
|
Patients' satisfaction
Time Frame: 2 years follow-up
|
Patients' satisfaction assessed by the official questionnaire of the national association of the quality development in hospitals (ANQ)
|
2 years follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Matthias Jäger, MD, Psychiatric University Hospital, Zurich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2017
Primary Completion (Anticipated)
November 1, 2020
Study Completion (Anticipated)
November 1, 2020
Study Registration Dates
First Submitted
October 19, 2017
First Submitted That Met QC Criteria
October 24, 2017
First Posted (Actual)
October 25, 2017
Study Record Updates
Last Update Posted (Actual)
October 25, 2017
Last Update Submitted That Met QC Criteria
October 24, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HT201701349
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.