UMIN-CTR Clinical Trial

Basic information
Public title	Survey and interventional research on Utilization behaviors in health care and treatment outcomes for emergency psychiatry patients
Acronym	SIUTEP
Scientific Title	Survey and interventional research on Utilization behaviors in health care and treatment outcomes for emergency psychiatry patients
Scientific Title:Acronym	SIUTEP
Region	Japan

Condition
Condition	(1) all emergency psychiatry patients at Iwate Medical University from April 1, 1998 (when the emergency psychiatry system was formed by Iwate Prefecture) to March 31, 2009 and (2) all emergency psychiatry patients at Iwate Medical University from April 1, 2009 to March 31, 2012.
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this research is to elaborate the effectiveness of emergency psychiatry services through a survey of treatment modality, background, presenting status, diagnosis, treatment, and outcomes of emergency psychiatry services provided to subjects comprising emergency psychiatry patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	outcome of emergency psychiatry
Key secondary outcomes	Visit date immediately after emergency visit, visit duration, treating medical facility, new recurrence, emergency visit category, status presented at visit, diagnosis, symptom evaluation, treatment provided, GAS, BPRS, LCU, manifestation of suicidal ideation, consultation y/n, consultant, consultation interval

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver Other
Interventions/Control_1	Emergency psychiatry System: Information collection, testing, clinical evaluation, physical treatment, psychiatric treatment (psychiatric therapy, drug therapy, other), inpatient treatment, outpatient treatment, social support, psychotherapy, community care
Interventions/Control_2	Emergency psychiatry in Critical Care Center: Information collection, testing, clinical evaluation, physical treatment, psychiatric treatment (psychiatric therapy, drug therapy, other), inpatient treatment, outpatient treatment, social support, psychotherapy, community care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) all emergency psychiatry patients at Iwate Medical University from April 1, 1998 (when the emergency psychiatry system was formed by Iwate Prefecture) to March 31, 2009 and (2) all emergency psychiatry patients at Iwate Medical University from April 1, 2009 to March 31, 2012.
Key exclusion criteria	non-psychiatry patients
Target sample size	18500

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akio Sakai
Organization	Iwate Medical University
Division name	Department of Neuropsychiatry
Zip code
Address	19-1, Uchimaru, Morioka, Iwate, 020-8505, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Kotaro Otsuka
Organization	Iwate Medical University
Division name	Department of Neuropsychiatry
Zip code
Address	19-1, Uchimaru, Morioka, Iwate, 020-8505, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Department of Neuropsychiatry, Iwate Medical University
Institute
Department

Funding Source
Organization	Department of Neuropsychiatry, Iwate Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 10 Month 21 Day
Last modified on	2010 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005285

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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