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Evaluating the effect of systematic patient and family education in the psychiatric emergency room on the process of receiving mental health care services

Protocol summary

Study aim
Evaluating the effect of systematic patient and family education in the psychiatric emergency room on the process of receiving mental health care services
Design
A clinical trial with a control and experiment group, single-blind and randomized, a sample size of 100 and randomization method is simple randomization
Settings and conduct
This study is conducted in Emergency Department of Razi Hospital,Tabriz. Four weeks after inclusion, a telephone call was made to enrolled patients and questions were asked about intended variables. Then reported results from bot groups were compared to estimate effect of the education on process of receiving health care after discharge from emergency room. The person who took the information by phone calls, is blinded to the assigned group of the patient.
Participants/Inclusion and exclusion criteria
inclusion criteria: Ability and willingness to give informed consent Exclusion criteria: Impaired conscientiousness Absence of family members
Intervention groups
In this study, in the experimental group, a 15-minute educational session is provided for each patient . The content of the training includes the name of the disease/disorder, symptoms, etiology, possible treatments and its prognosis, which is provided by psychiatry residents of Department of psychiatry,Tabriz University of Medical Sciences will be provided.
Main outcome variables
Frequency of visits to the emergency room or clinic, the frequency of visits to treating doctor, referral to other specialists, medications and their use, Symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180928041165N1
Registration date: 2018-12-03, 1397/09/12
Registration timing: retrospective

Last update: 2018-12-03, 1397/09/12
Update count: 0
Registration date
2018-12-03, 1397/09/12
Registrant information
Name
Mehrdad Ghaemmaghami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3380 4486
Email address
mehrdad.ghaem25@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2018-09-11, 1397/06/20
Actual recruitment start date
2018-06-06, 1397/03/16
Actual recruitment end date
2018-09-22, 1397/06/31
Trial completion date
2018-10-27, 1397/08/05
Scientific title
Evaluating the effect of systematic patient and family education in the psychiatric emergency room on the process of receiving mental health care services
Public title
Evaluating the effect of systematic education on the process of receiving mental health care services
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ability and willingness to informed consent
Exclusion criteria:
Absence of family members Impaired consciousnesses
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 100
Actual sample size reached: 115
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Simple Randomization Unit: Individual Randomization Tool: Envelope Shuffling Concealment: Simple
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients in the test and control groups are unaware of which group they are in, but they are aware of the existence of different study groups.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Razi Hospital,Sheykh Mohammad Khiyabani Ave, Elgoli,Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Approval date
2018-04-23, 1397/02/03
Ethics committee reference number
IR.TBZMED.REC.1397.096

Health conditions studied

1

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

2

Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

3

Description of health condition studied
Conversion disorder
ICD-10 code
F44
ICD-10 code description
Dissociative and conversion disorders

4

Description of health condition studied
Panic disorder
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety] without agoraphobia

5

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

6

Description of health condition studied
Alcohol related disorders
ICD-10 code
F10
ICD-10 code description
Alcohol related disorders

7

Description of health condition studied
Opioid related disorders
ICD-10 code
F11
ICD-10 code description
Opioid related disorders

8

Description of health condition studied
Cannabis related disorders
ICD-10 code
F12
ICD-10 code description
Cannabis related disorders

9

Description of health condition studied
Sedative related disorders
ICD-10 code
F13
ICD-10 code description
Sedative, hypnotic, or anxiolytic related disorders

10

Description of health condition studied
Cocaine related disorders
ICD-10 code
F14
ICD-10 code description
Cocaine related disorders

11

Description of health condition studied
Other stimulant related disorders
ICD-10 code
F15
ICD-10 code description
Other stimulant related disorders

12

Description of health condition studied
Hallucinogen related disorders
ICD-10 code
F16
ICD-10 code description
Hallucinogen related disorders

13

Description of health condition studied
Nicotine dependence
ICD-10 code
F17
ICD-10 code description
Nicotine dependence

14

Description of health condition studied
Inhalant related disorders
ICD-10 code
F18
ICD-10 code description
Inhalant related disorders

15

Description of health condition studied
Other psychoactive substance related disorders
ICD-10 code
F19
ICD-10 code description
Other psychoactive substance related disorders

Primary outcomes

1

Description
Frequency of visits to the emergency room or clinic, frequency of visits to treating doctor, the referral to other specialists, medications and their use it, symptoms
Timepoint
Study of the variables before intervention and 4 weeks after the end of the intervention
Method of measurement
The questionnaire designed by the researcher

Secondary outcomes

1

Description
change of symptoms
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Questionnaire designed by researcher and description of the patient's family

Intervention groups

1

Description
In the intervention group, one session of "psycho-education" with predefined content will be provided. The content of this session includes: the name of the disease/disorder, symptoms, signs, etiology, possible treatments and the prognosis. This 15-minute , interactional session will be provided by psychiatry residents of Department of Psychiatry, Tabriz University of Medical Sciences.
Category
Other

2

Description
Control group: This group will receive the routine care and routine educational materials within the emergency room.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital of Tabriz
Full name of responsible person
Mahsa Raji
Street address
Razi Hospital,Sheykh Mohammad Khiyabani Ave, Elgoli,Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
info@prazi.tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Juyban
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Phone
+98 41 3335 5921
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrdad Ghaemmaghami
Position
assitant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Razi Hospital,Sheykh Mohammad Khiyabani Ave, Elgoli,Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
Mehrdad.ghaem25@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrdad Ghaemmaghami
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Razi Hospital,Sheykh Mohammad Khiyabani Ave, Elgoli,Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
Mehrdad.ghaem25@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrdad Ghaemmaghami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Razi Hospital,Sheykh Mohammad Khiyabani Ave, Elgoli,Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
Mehrdad.ghaem25@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
In this study, only data on changes in symptoms and the frequency of referral to an emergency room or clinic, the frequency of referral to treating doctor, referral to other professionals, medications and their use will be provided.
When the data will become available and for how long
one year after publication.
To whom data/document is available
Researchers working in academic and Scientific institutions
Under which criteria data/document could be used
research in the field of mental health services
From where data/document is obtainable
1-Library of Tabriz University of Medical Sciences 2- Library of Razi Hospital in Tabriz 3- Contact the mahsaraji90@gmail.com email address
What processes are involved for a request to access data/document
Contact with the corresponding author via email, and answer will be provided within 72 hours
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