UMIN-CTR Clinical Trial

Basic information
Public title	A systematic review of return to community for long-term psychiatric inpatients
Acronym	A systematic review of return to community for long-term psychiatric inpatients
Scientific Title	Readmission and school/work engagement after discharge from psychiatric hospitals among long-stay patients with severe mental illness: A systematic review of the literature
Scientific Title:Acronym	Readmission and school/work engagement after discharge from psychiatric hospitals among long-stay patients with severe mental illness: A systematic review of the literature
Region	Japan

Condition
Condition	severe mental illness
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this systematic review is to examine readmission rates, readmission days, employment rates, and school enrollment rates after discharge focusing on psychiatric patients hospitalized for more than one year with a severe mental illness. P:Adults with SMI E:long-term (i.e. 1 year or longer) inpatient care in psychiatric hospitals or psychiatric wards in general hospitals O:readmission, number of days in hospitals, number of days in community, and school/work engagement or other social participation after discharge S:observational study, cohort study, and randomized controlled trial
Basic objectives2	Others
Basic objectives -Others	Same as above
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Readmission rate defined as the percentage of patients hospitalised during the first year after discharge and days of readmission defined as the number of days of hospitalization in the year after discharge
Key secondary outcomes	1)Readmission rates and readmission days within the follow-up period set by each study, other than those described in the previous section 2)Percentage of those discharged from hospitals who were employed enrolled in school or participated in social activities such as volunteering within the follow-up period set by each study 3)Level of severity in psychiatric symptoms measured by rating scales (e.g. PANSS, BPRS), level of social functioning measured by rating scales (e.g. GAF), quality of life, and well-being measured by self-report questionnaires (e.g.WHO-QOL26, SF36) at the end of the follow-up period set by each study

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	18 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	adults aged between 18 and 64 with diagnosis of severe mental illness who have been hospitalized 1 year or longer and were discharged from psychiatric inpatient care
Key exclusion criteria	Single diagnosis of mental disorders due to known physiological conditions (ICD-10 F0); psychoactive substance use (F1); anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders (F4); eating disorders (F50); adult personality and behavior (F6); intellectual disabilities (F7); or pervasive and specific developmental disorders (F8).
Target sample size

Research contact person
Name of lead principal investigator	1st name Sayaka Middle name Last name Sato
Organization	National Institute of Mental Health, NCNP
Division name	Department of Community Mental Health & Law
Zip code	1878553
Address	4-1-1 Ogawa-higashi Kodaira Tokyo Japan
TEL	0423462039
Email	sayakas@ncnp.go.jp

Public contact
Name of contact person	1st name Sayaka Middle name Last name Sato
Organization	National Institute of Mental Health, NCNP
Division name	Department of Community Mental Health & Law
Zip code	187-8553
Address	4-1-1 Ogawa-higashi Kodaira Tokyo Japan
TEL	0423462039
Homepage URL
Email	sayakas@ncnp.go.jp

Sponsor
Institute	National Institute of Mental Health, NCNP
Institute
Department

Funding Source
Organization	National Institute of Mental Health, NCNP
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Institute of Mental Health, NCNP
Address	4-1-1 Ogawa-higashi Kodaira Tokyo Japan
Tel	0423462039
Email	sayakas@ncnp.go.jp

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	2020 Year 05 Month 01 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	Preinitiation
Date of protocol fixation	2019 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 10 Month 31 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will report a narrative synthesis. Specifically, the country, year of publication, readmission rate, and the number of days of readmission for each article are summarized in a table. We will use meta-analytic techniques, if appropriate. If there are ten or more studies in the systematic review, we will examine publication bias by visual inspection of funnel plots.

Management information
Registered date	2020 Year 04 Month 27 Day
Last modified on	2020 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045749