NCT01719354

Brief Summary

This is a trial to examine the effects of aftercare for mental health patients in community health center (Leistad). Recruitment occurs among hospitalized patients in psychiatric hospitals (Østmarka). After discharge, patients will be randomly assigned to one of two groups: intervention group (community health center, primary care) or control group (Community mental health centers of District Psychiatric Service, specialist care). The project's primary objective is to investigate the effect of community services on patients' functional capacity and user satisfaction after discharge. Secondly, the number of treatment days and readmissions to mental health care will be examined. The project will also compare costs of hospitalization, in psychiatric hospital and community health center respectively. Data will be collected from community health records, medical records and patient systems in psychiatric hospital, community mental health centers of District Psychiatric Service (DPS) and questionnaires filled out by patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

October 30, 2012

Last Update Submit

February 12, 2017

Conditions

Mental Disorders

Keywords

Community Mental Health CentersNorwayAftercare

Outcome Measures

Primary Outcomes (4)

  • Consumption of community health service

    Measure different types of community health services in hours per week.

    one year

  • Need for community health services

    Using IPLOS (Norw. individual-based nursing and care statistics) form with 17 variables to identify patient needs

    one year

  • User satisfaction

    A qualitative analysis of interviews of 10 patients who have been admitted to the District Psychiatric Service and community health center.

    one year

  • Need for community health services

    Using individual-based nursing and care statistics (Norw. IPLOS) form with 17 variables to identify patient needs

    one year

Secondary Outcomes (3)

  • Number of treatment days

    One year

  • Readmission

    One year

  • The total costs of inpatient and total costs of all health care after discharge

    One year

Study Arms (2)

Community Health center

EXPERIMENTAL

Aftercare in a community Health center

Other: Community Health center

Control

ACTIVE COMPARATOR

AFtercare as usual in hospital/Mental health centers of District Psychiatric Service (DPS.

Other: Control

Interventions

Community Health centerOTHER

Observation of the functioning and coordination of health care before discharge to own home.

Community Health center
ControlOTHER

standard aftercare in hospital/mental health centers of District Psychiatric Service (DPS).

Control

Eligibility Criteria

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

You may qualify if:

  • considered by the responsible manager to have given consent
  • hospitalized, diagnosed and treated such as can be continued in a District Psychiatric Service or a health center.
  • stable condition, but anxiety and disruptive behavior may occur to a lesser extent.
  • considered to have a perceived need for complex services from specialist health and community for a long time after discharge.

You may not qualify if:

  • not in a stable phase thus shielding required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Committees for Medical and Health Research Ethics

Trondheim, 7489, Norway

Location

Related Publications (1)

  • Roos E, Bjerkeset O, Steinsbekk A. Health care utilization and cost after discharge from a mental health hospital; an RCT comparing community residential aftercare and treatment as usual. BMC Psychiatry. 2018 Nov 12;18(1):363. doi: 10.1186/s12888-018-1941-2.

    PMID: 30419894DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Community Health Centers

Intervention Hierarchy (Ancestors)

Ambulatory Care FacilitiesHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Aslak Steinsbekk, prof

    NTNU, Department of Public Health and General Practice

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2012

First Posted

November 1, 2012

Study Start

January 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

NO(1)