NCT02322437

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
707

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

3 years

First QC Date

December 11, 2014

Last Update Submit

June 3, 2018

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (1)

  • Number of inpatient days

    2 years follow-up

Secondary Outcomes (8)

  • 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)

    Intake and discharge from treatment episode (expected average of 4 weeks)

  • Brief Symptom Checklist (BSCL)

    Intake and discharge from treatment episode (expected average of 4 weeks)

  • Perceptions of Care-18

    Discharge from treatment episode (expected average of 4 weeks)

  • +3 more secondary outcomes

Study Arms (2)

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

Home treatmentOTHER

Patients are treated at home whenever possible and appropriate

Home treatment
Treatment As UsualOTHER

Patients are treated at a mental hospital

Treatment as usual

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Services Aargau AG

Brugg, Canton of Aargau, 5201, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 30864532DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Therapeutics

Study Officials

  • Niklaus Stulz, PhD

    Psychiatric Services Aargau AG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 23, 2014

Study Start

April 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

CH(1)