UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061781 |
|---|---|
| Receipt number | R000070697 |
| 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 | 2026/07/01 |
| Last modified on | 2026/06/03 13:21:14 |
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Basic information
Public 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 -
Acronym
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
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
An interrupted time-series study to improve peripherally inserted central venous catheter assessment and decision making in hospital patients - The I-DECIDED-PICC Study -
Region
| Japan |
Condition
Condition
Patients who have a PICC inserted
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of the I-DECIDED PICC Device Assessment and Decision Tool in improving the assessment, management, and timely removal of PICCs in hospitalized adult acute care patients.
The specific objectives are as follows:
1. To evaluate whether the I-DECIDED PICC Tool improves healthcare professionals awareness and understanding of appropriate PICC use.
2. To evaluate whether the I-DECIDED PICC Tool reduces the prevalence of unnecessary PICC dwell.
3. To evaluate whether the I-DECIDED PICC Tool reduces the incidence of PICC-related complications.
4. To evaluate whether the I-DECIDED PICC Tool reduces the incidence of central line-associated bloodstream infections (CLABSIs) associated with PICCs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Prevalence of Unnecessary PICC Use
An unnecessary PICC is defined as a PICC documented in the patients medical record that has no current or anticipated medical indication within the previous 48 hours or the subsequent 48 hours.
For PICCs inserted due to difficult peripheral intravenous access (DIVA):
Previous 48 hours:
No administration of intravenous medications through the PICC.
Next 48 hours:
No active orders for intravenous medications through the PICC.
No documented plan indicating anticipated intravenous therapy (i.e. no relevant documentation in the medical record).
For PICCs inserted because central venous access was required for medication administration:
Previous 48 hours:
No administration of medications requiring central venous access.
Next 48 hours:
No active orders for medications requiring central venous access.
No documented plan indicating anticipated administration of medications requiring central venous access (i.e. no relevant documentation in the medical record).
Exclusion Criterion Planned Long-Term Intravenous Therapy
A PICC will not be classified as an unnecessary device, regardless of medication administration within the 48-hour assessment window, if the patient meets either of the following criteria:
Ongoing intravenous therapy or planned intravenous therapy expected to continue for 14 days or longer, including but not limited to:
Long-term antimicrobial therapy for conditions such as infective endocarditis, osteomyelitis, or persistent bloodstream infection;
Long-term parenteral nutrition;
Chemotherapy; or
Any other treatment plan requiring central venous or long-term peripheral vascular access for more than 14 days.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 18 years or older who are newly admitted to the participating study wards.
Patients with a peripherally inserted central catheter (PICC) in place.
Key exclusion criteria
Patients who do not provide informed consent to participate in the study.
Patients whom the treating physician determines are unsuitable for study participation.
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 Critical Care Medicine
Zip code
330-0834
Address
1-847, Amanuma-cho, Oomiya-ku, Saitama-shi, Saitama, 330-0834, 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 Critical Care Medicine
Zip code
330-0834
Address
1-847, Amanuma-cho, Oomiya-ku, Saitama-shi, Saitama, 330-0834, 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
1-847, Amanuma-cho, Oomiya-ku, Saitama-shi, Saitama, 330-0834, 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 | 07 | 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
| 2026 | Year | 06 | Month | 01 | 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 | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070697
