- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01719354
Aftercare in the Community Health Center
Aftercare in the Community Health Center - a Venue for Identifying and Coordinating Community Services
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Trondheim, Norway, 7489
- Regional Committees for Medical and Health Research Ethics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- not in a stable phase thus shielding required
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Community Health center
Aftercare in a community Health center
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Observation of the functioning and coordination of health care before discharge to own home.
|
|
Active Comparator: Control
AFtercare as usual in hospital/Mental health centers of District Psychiatric Service (DPS.
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standard aftercare in hospital/mental health centers of District Psychiatric Service (DPS).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Consumption of community health service
Time Frame: one year
|
Measure different types of community health services in hours per week.
|
one year
|
|
Need for community health services
Time Frame: one year
|
Using IPLOS (Norw.
individual-based nursing and care statistics) form with 17 variables to identify patient needs
|
one year
|
|
User satisfaction
Time Frame: one year
|
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
Time Frame: one year
|
Using individual-based nursing and care statistics (Norw.
IPLOS) form with 17 variables to identify patient needs
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of treatment days
Time Frame: One year
|
Number of treatment days in hospital and District Psychiatric Service compared with number of treatment days in community health center.
|
One year
|
|
Readmission
Time Frame: One year
|
Readmission in hospital.
|
One year
|
|
The total costs of inpatient and total costs of all health care after discharge
Time Frame: One year
|
Costs per day in hospital; Costs per day for District Psychiatric Service; Costs per day in community health center
|
One year
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Aslak Steinsbekk, prof, NTNU, Department of Public Health and General Practice
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/1770
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