UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044154
Receipt number R000050409
Scientific Title A survey on the variation of medical costs according to the incidence level of perioperative delirium
Date of disclosure of the study information 2021/05/10
Last modified on 2021/05/10 12:04:47

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Basic information

Public title

A survey on the variation of medical costs according to the incidence level of perioperative delirium

Acronym

A survey on the variation of medical costs according to the incidence level of perioperative delirium

Scientific Title

A survey on the variation of medical costs according to the incidence level of perioperative delirium

Scientific Title:Acronym

A survey on the variation of medical costs according to the incidence level of perioperative delirium

Region

Japan


Condition

Condition

Delirium

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to determine the extent to which medical costs (hospitalization costs and medical resource inputs) increase or decrease with the onset and severity of delirium in Japanese ICUs.

Basic objectives2

Others

Basic objectives -Others

Medical economic impact

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Medical costs

Key secondary outcomes

Length of hospitalization


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients admitted on or after April 1, 2016 and discharged by March 31, 2018.2)Kawasaki Medical School Hospital: Patients admitted to ICU after cardiovascular surgery.
3)Kawasaki Medical School General Medical Center: Patients admitted to the ICU after esophageal cancer surgery

Key exclusion criteria

1) 20 years old or younger
2) Patients with a history of mental illness

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Koga

Organization

Kawasaki University of Medical Welfare

Division name

Department of Nursing Faculty of Health and Welfare

Zip code

701-0193

Address

288,Matsushima,Kurashiki,Okayama, Japan

TEL

086-462-1111

Email

y.koga@mw.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Koga

Organization

Kawasaki University of Medical Welfare

Division name

Department of Nursing Faculty of Health and Welfare

Zip code

701-0193

Address

288,Matsushima,Kurashiki,Okayama, Japan

TEL

086-462-1111

Homepage URL


Email

y.koga@mw.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki University of Medical Welfare

Institute

Department

Personal name



Funding Source

Organization

Kawasaki University of Medical Welfare

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

Kawasaki University of Medical Welfare

Address

288,Matsushima,Kurashiki,Okayama, Japan

Tel

086-462-1111

Email

kenkyu@mw.kawasaki-m.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

3147

Org. issuing International ID_1

Kawasaki Medical School

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

川崎医科大学附属病院(岡山県)、川崎医科大学総合医療センター(岡山県)


Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 10 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

122

Results

2 hospitals122 participants
Age 72.50years(Median)
Cardiovascular surgery:86.9%
male patients:65.6%

Non delirium(NDg):26.2%
Subsyndromal delirium (SDg):43.4%
Delirium(Dg):30.4%

Medical costs(Median)
NDg:34648.30USD
SDg:45596.54USD
Dg:53546.04USD
There was a significant difference in the comparison between all groups(p<0.01),

Length of hospitalization(Median)
NDg 22days,SDg 27days,Dg 31days.NDg was significantly different from Dg(p<0.01).

Results date posted

2021 Year 05 Month 08 Day

Results Delayed

Delay expected

Results Delay Reason

Unregistered

Date of the first journal publication of results

2021 Year 05 Month 08 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 06 Month 22 Day

Date of IRB

2018 Year 08 Month 03 Day

Anticipated trial start date

2018 Year 08 Month 04 Day

Last follow-up date

2018 Year 09 Month 30 Day

Date of closure to data entry

2021 Year 05 Month 08 Day

Date trial data considered complete

2021 Year 05 Month 08 Day

Date analysis concluded

2021 Year 05 Month 08 Day


Other

Other related information

We will list patients who meet the conditions described in the "Patients to be surveyed" section at the medical affairs section of the hospital, and obtain information on the patient's basic background, D file, EF integration file, H file, and total hospitalization cost from the medical record number and DPC data.
Then, information on the onset of delirium during ICU stay and the duration of ICU stay are collected from the electronic medical record using the medical record number.


Management information

Registered date

2021 Year 05 Month 10 Day

Last modified on

2021 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050409


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name