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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034217
Receipt No. R000039006
Scientific Title Impact of physician volume and specialty on in-hospital mortality of ischemic and haemorrhagic stroke: J-ASPECT Study
Date of disclosure of the study information 2018/09/20
Last modified on 2018/09/30

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Basic information
Public title Impact of physician volume and specialty on in-hospital mortality of ischemic and haemorrhagic stroke: J-ASPECT Study
Acronym Physician Volume Study
Scientific Title Impact of physician volume and specialty on in-hospital mortality of ischemic and haemorrhagic stroke: J-ASPECT Study
Scientific Title:Acronym Physician Volume Study
Region
Japan

Condition
Condition Ischemic stroke, intracerebral haemorrhage (ICH), and subarachnoid haemorrhage (SAH)
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Association between physician volume and death rate in patients who are hospitalized for ischemic and haemorrhagic stroke remains unclear. It is unknown whether a volume threshold for such an association exists. We aimed to analyse the correlation between in-hospital stroke mortality and physician volume, considering board certification status.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 30 day mortality after the hospitalaization for stroke
Key secondary outcomes

Base
Study type Observational

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
1 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria We identified patients hospitalized for stroke in a deidentified discharge database using the International Classification of Diseases (ICD)10 diagnosis codes related to ischemic stroke (I63 0to9), nontraumatic intracerebral haemorrhage (ICH I61 0 to9) and subarachnoid haemorrhage (SAH I60 0to9). Because of major differences in their typical prognosis, patients with transient ischemic attack were excluded. We further selected those patients who had been urgently admitted between 1 April 2010 and 31 March 2016 to the hospitals.
Key exclusion criteria Non emergent cases
Target sample size 400000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Iihara
Organization Kyushu University, Graduate School of Medical Sciences
Division name Department of Neurosurgery
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL +81-92-642-5521
Email kiihara@ns.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Iihara
Organization Department of Neurosurgery
Division name 3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
Zip code
Address +81-92-642-5521
TEL +81-92-642-5521
Homepage URL
Email kiihara@ns.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University, Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
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
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
2018 Year 09 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
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 From 295,150 (ischemic stroke), 98,657 (ICH), and 36,174 (SAH) patients, 30day inhospital mortality rates were 4, 16, and 26%. For all stroke types, the number of stroke care physicians was associated with reduced in-hospital mortality (all p for trend<0.001). The numbers of board-certified neurosurgeons, stroke physicians, and endovascular surgeons showed clear association with reduced in-hospital mortality for ischemic stroke

Management information
Registered date
2018 Year 09 Month 20 Day
Last modified on
2018 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039006

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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