Home Treatment for Acute Psychiatric Care | NCT02322437

Studies
Home Treatment for Acute Psychiatric Care

NCT02322437

Sponsor

Psychiatric Services Aargau AG

Status

Completed

Last Update Posted

Jun 6, 2018Actual

Enrollment

707Actual

Phase

Not Applicable

Conditions

Mental Disorders

Interventions

Home treatment
Treatment As Usual

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Dec 11, 2014

First Submission Date that Met QC Criteria

Dec 22, 2014

First Posted Date

Dec 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2018

Last Update Posted Date

Jun 6, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Niklaus Stulz, PhD, Psychiatric Services Aargau AGPrincipal Investigator

Lead Sponsor

Psychiatric Services Aargau AGOTHER

Collaborators

Name	Class
Hugo & Elsa Isler Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate whether psychiatric home treatment is an effective and efficient alternative to acute inpatient care in mental hospitals. A one-year prevalence cohort of psychiatric patients in need of hospitalization are randomly assigned to either treatment at inpatient wards (treatment as usual) or a new care model with the additional option of treating patients at their homes by mobile care teams. The primary focus is on checking whether optional home treatment leads to a reduction of inpatient days during a two-year follow-up period. In addition, the two service models will be compared regarding treatment cost and outcomes as well as satisfaction of patients and their relatives with psychiatric care.

Furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be examined by a highly trained clinical assessor to test and verify the diagnoses and the clinical ratings made by the staff members of the mental hospital under routine everyday conditions.

Detailed Description

This study aims to evaluate whether psychiatric home treatment is an effective and efficient alternative to acute inpatient care in mental hospitals. A one-year prevalence cohort of psychiatric patients in need of hospitalization are randomly assigned to either treatment at inpatient wards (treatment as usual) or a new care model with the additional option of treating patients at their homes by mobile care teams. The primary focus is on checking whether optional home treatment for crisis intervention leads to a reduction of inpatient days during a two-year follow-up period. In addition, the two service models will be compared regarding treatment cost and outcomes as well as satisfaction of patients and their relatives with psychiatric care.

Furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be examined by a highly trained clinical assessor to test and verify the diagnoses (SCID-I and SCID-II) and the clinical ratings (HoNOS) made by the staff members of the mental hospital under routine everyday conditions.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

707Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Home treatment	Experimental	Patients in need of acute psychiatric inpatient care are treated at their houses by mobile treatment teams instead of treatment at mental hospitals whenever home treatment is possible and appropriate.	Other: Home treatment
Treatment as usual	Active Comparator	Patients in need of acute psychiatric inpatient care are treated at a mental hospital.	Other: Treatment As Usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Home treatment	Other	Patients are treated at home whenever possible and appropriate	Home treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of inpatient days		2 years follow-up

Secondary Outcomes

Measure	Description	Time Frame
Total days in treatment (inpatient + home treatment)		2 years follow-up
Direct treatment costs		2 years follow-up
Health of the Nation Outcome Scales (HoNOS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Need for acute psychiatric inpatient care
Residence in the canton of Aargau
Living within 30 minutes (by car) from the headquarters of the home treatment team
Health insurance with tarifsuisse

Exclusion Criteria:

Insufficient proficiency in German
Main diagnosis F0 or F1 (ICD-10)
Patients of the forencic departement
Patients of the child and adolescent department

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Niklaus Stulz, PhD	Psychiatric Services Aargau AG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Psychiatric Services Aargau AG		Brugg	Canton of Aargau	5201	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30864532	Derived	Stulz N, Wyder L, Maeck L, Hilpert M, Lerzer H, Zander E, Kawohl W, Grosse Holtforth M, Schnyder U, Hepp U. Home treatment for acute mental healthcare: randomised controlled trial. Br J Psychiatry. 2020 Jun;216(6):323-330. doi: 10.1192/bjp.2019.31.