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Comparing the Outcomes and Cost-effectiveness of Two Model of Case-manager system for Severe Mentally Ill Patients: general practitioner and nurses.

Protocol summary

Summary
The objective of this study is to compare the clinical outcomes and cost-effectiveness of two models of case-manager services (home-visit) for serious mentally ill patients by general practitioners and nurses. The target population is the individuals with schizophrenia and bipolar mood disorders spectrum living in Karaj. 180 participants will be selected from mental hospitals or wards after discharge or from outpatients services and randomly allocated into three treatment groups. In the first group, the intervention will be carried out by general practitioners by providing 12-month consequences home-visit. In each visit, the patients will be supervised for their medication prescribed by the patient's psychiatrist, the patient and caregivers are trained, the symptoms of disease and the drugs side effects are reported to the patient’s psychiatrist, and finally drugs are prescribed if urgently needed. In the second group, except for prescribing drugs, the same services will be provided by a nurse. In the third group no intervention will be provided. The instruments of YMRS, FEIS, PANSS, caregiver's knowledge questionnaire, KELS, quality of life-36, CSQ-8, GHQ, cost questionnaire will be used to measure clinical outcomes and cost-effectiveness of the interventions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138807251959N3
Registration date: 2010-08-31, 1389/06/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-08-31, 1389/06/09
Registrant information
Name
Seyed Kazem Malakouti
Name of organization / entity
Iran University of Medical Science - Tehran Psychiatric Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 0200
Email address
malakouti.k@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ministry of Health, Mental Health Bureau, Family Research Institute of University of Shahid Beheshti, Mental Health Research Center, Mental Health Research Network, University of Social Welfare and Rehabilitation.
Expected recruitment start date
2010-03-06, 1388/12/15
Expected recruitment end date
2010-09-22, 1389/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Outcomes and Cost-effectiveness of Two Model of Case-manager system for Severe Mentally Ill Patients: general practitioner and nurses.
Public title
Aftercare Services for severe mentally ill patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Presence of schizophrenia or bipolar spectrum disorders, age 15-60 years old, having at least one hospitalization history for exacerbation in her/his past history, need for aftercare services according to his/her psychiatrist due to low level of compliance Exclusion criteria: having organic brain disorder, having concurrently substance use disorders, using similar services from other sources
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran Psychiatric Institute Ethic Committee
Street address
Shahied Mansuri St., Niayesh St., Sattarkhan Ave., Tehran
City
Tehran
Postal code
1443813444
Approval date
2010-12-01, 1389/09/10
Ethics committee reference number
06/22/10/88

Health conditions studied

1

Description of health condition studied
schizopherenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

2

Description of health condition studied
schizoaffective disorder
ICD-10 code
F25
ICD-10 code description
Schizoaffective disorders

3

Description of health condition studied
Bipolar affective disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder

Primary outcomes

1

Description
relapse and rehospitalization due to exacerbation of disorder
Timepoint
at the beginning and after 12 months of intervention
Method of measurement
observing the course of disease

2

Description
caregiver's knowledge
Timepoint
at the beginning and after 12 months of intervention
Method of measurement
caregiver's knowledge questionnaire

3

Description
caregiver's burden
Timepoint
at the beginning and after 12 months of intervention
Method of measurement
Family burden interview scale

4

Description
health of caregiver
Timepoint
at the beginning and after 12 months of intervention
Method of measurement
general health questionnaire

5

Description
patient's satisfaction from services
Timepoint
at the beginning and after 12 months of intervention
Method of measurement
client satisfaction questionnaire-8

6

Description
patient's quality of life
Timepoint
at the beginning and after 12 months of intervention
Method of measurement
quality of life questionnaire-36

7

Description
cost of treatment, cost-effective evaluation
Timepoint
at the beginning and after 12 months of intervention
Method of measurement
cost questionnaire

8

Description
life skills of patients
Timepoint
at the beginning and after 12 months of intervention
Method of measurement
KELZ life skill scale

9

Description
severity of psychopathology
Timepoint
before and after one year of intervention
Method of measurement
Young Mania Rating Scale (YMRS), Positive and Negative Syndrome Scale (PANSS)

Secondary outcomes

empty

Intervention groups

1

Description
The participants receive home-visit by a general practitioner monthly for 12 consecutive months. GPs supervise the patients' drug treatment according to the patients' psychiatrist prescription, train the patient and her/his caregivers according to 12-month topics, report the patients mental status/drug side effects to the psychiatrist, and prescribe drugs in case of emergency and necessities.
Category
Prevention

2

Description
The participants receive home-visit by a nurse monthly for 12 consecutive months. Nurses supervise the patients' drug treatment according to the patients' psychiatrist prescription, train the patient and her/his caregivers according to 12-month topics, report the patients mental status/drug side effects to the psychiatrist
Category
Prevention

3

Description
The control group receives the treatment facilities which are available "as usual services" from society. They are contacted by telephone each 3- month to complete the cost questionnaire.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
RasooL Akram hospital, inpatient and outpatient servies
Full name of responsible person
Seyed Kazem Malakouti
Street address
Niayesh St., Sattarkhan Ave., Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Iran hospital
Full name of responsible person
Neda Esmaeli
Street address
Km 6, Karaj specific road, Tehran
City
Tehran

3

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Arash Mirabzadeh
Street address
City
Tehran

4

Recruitment center
Name of recruitment center
private offices of Dr. Hajian Motlagh, Dr. Abdollha sani, Dr. Bayat Makoo, Dr. Rastegar
Full name of responsible person
Seyed Kazem Malakouti
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mental Health Research Center
Full name of responsible person
Dr. Mehrdad Eftekhar
Street address
mansouri st. niayesh st. Sattarkhan Ave. Tehran Psychiatric Institute
City
tehran
Grant name
Grant code / Reference number
5773
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mental Health Research Center
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Mental Health Research Network
Full name of responsible person
Dr. Jafar Bolhari
Street address
Mansuri st. niayesh st. Sattarkhan Ave. Tehran Psychiatric Institute
City
Tehran
Grant name
Grant code / Reference number
3077
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mental Health Research Network
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

3

Sponsor
Name of organization / entity
University of Social welfare and rehabilitaion
Full name of responsible person
Dr. Arash Mirabzadeh
Street address
Rey district, Amin Abad, Razi hospital
City
Tehran
Grant name
Grant code / Reference number
801/4/88/178
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social welfare and rehabilitaion
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

4

Sponsor
Name of organization / entity
Family research institute, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Narjes Chimeh
Street address
Daneshjoo Blvd., Yaman st., Chamran highway,
City
Tehran
Grant name
Grant code / Reference number
850/41
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Family research institute, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences- Tehran Psychiatric Institute
Full name of responsible person
Dr. Seyed Kazem Malakouti
Position
Fellow, Geriatric Psychiatry
Other areas of specialty/work
Street address
Shahied Mansuri St; Niayesh St; Sattarkhan Ave; Tehran
City
Tehran
Postal code
1443813444
Phone
+98 21 6655 0200
Fax
+98 66550200
Email
kmalakouti@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Science - Tehran Psychiatric Institute
Full name of responsible person
Dr. Seyed Kazem Malakouti
Position
Fellow, Geriatric Psychiatry
Other areas of specialty/work
Street address
Shahid Mansuri St; Niayesh St; Sattarkhan Ave; Tehran
City
Tehran
Postal code
1443813444
Phone
+98 21 6655 0200
Fax
+98 21 6655 0200
Email
kmalakouti@iums.ac.ir
Web page address
www.iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences, Tehran Psychiatric Institute
Full name of responsible person
Dr. Seyed Kazem Malakouti
Position
fellow, Geriatric psychiatry
Other areas of specialty/work
Street address
Shahid Mansuri St; Niayesh St; Sattarkhan Ave; Tehran
City
Tehran
Postal code
1443813444
Phone
+98 21 6655 0200
Fax
+98 21 6655 0200
Email
kmalakouti@iums.ac.ir
Web page address
www.iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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