UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061461 |
|---|---|
| Receipt number | R000070334 |
| Scientific Title | An interrupted time-series study to improve peripherally inserted central venous catheter assessment and decision making in hospital patients - The I-DECIDED-PICC Study - |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/06 22:15:51 |
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Basic information
Public title
Study on Improving PICC Management Using I-DECIDED
Acronym
I-DECIDED PICC
Scientific Title
An interrupted time-series study to improve peripherally inserted central venous catheter assessment and decision making in hospital patients - The I-DECIDED-PICC Study -
Scientific Title:Acronym
I-DECIDED PICC Study
Region
| Japan |
Condition
Condition
Hospitalized patients with a PICC in place
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effectiveness of the I-DECIDED PICC device assessment and decision-making tool in improving the assessment, management, and timely removal of PICCs in acutely ill adult hospitalized patients.
The specific objectives are as follows:
To evaluate whether the I-DECIDED PICC tool improves healthcare professionals awareness of appropriate PICC use.
To evaluate whether the I-DECIDED PICC tool reduces the prevalence of unnecessary PICC dwell.
To evaluate whether the I-DECIDED PICC tool reduces the incidence of PICC-related complications.
To evaluate whether the I-DECIDED PICC tool reduces the incidence of PICC-related bloodstream infections (CLABSI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of unnecessary devices
Key secondary outcomes
Incidence of PICC-related bloodstream infections
Incidence of inappropriate dressings
Proportion of documented unnecessary device assessments
PICC utilization rate
Proportion of days with a documented device management plan in the electronic medical record
Usability of the I-DECIDED PICC tool, and barriers and facilitators to device assessment and decision-making
Proportion of PICCs assessed as unnecessary that were subsequently removed
Prevalence of unnecessary devices, defined as the primary outcome when blood sampling purposes are excluded from the definition of unnecessary devices
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 18 years or older newly admitted to the target wards
Patients with a PICC in place
Key exclusion criteria
Patients from whom consent to participate in the study cannot be obtained
Patients deemed unsuitable for study participation by the attending physician
Patients admitted for palliative care purposes
Target sample size
3200
Research contact person
Name of lead principal investigator
| 1st name | Hideto |
| Middle name | |
| Last name | Yasuda |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
330-0834
Address
847 Amanuma-cho 1-chome, Omiya-ku, Saitama-shi, Saitama, Japan
TEL
048-647-2111
yasudahideto@me.com
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Yasuda |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
330-0834
Address
847 Amanuma-cho 1-chome, Omiya-ku, Saitama-shi, Saitama, Japan
TEL
048-647-2111
Homepage URL
yasudahideto@me.com
Sponsor or person
Institute
Jichi Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University Saitama Medical Center
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
Jichi Medical University Saitama Medical Center
Address
847 Amanuma-cho 1-chome, Omiya-ku, Saitama-shi, Saitama, Japan
Tel
048-647-2111
yasudahideto@me.com
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
| 2026 | Year | 05 | Month | 07 | 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
| 2026 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 05 | Month | 06 | Day |
Last modified on
| 2026 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070334
