UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021894 |
|---|---|
| Receipt number | R000022960 |
| Scientific Title | Situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU. |
| Date of disclosure of the study information | 2016/04/13 |
| Last modified on | 2019/04/17 22:10:52 |
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Basic information
Public title
Situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Acronym
Situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Scientific Title
Situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Scientific Title:Acronym
Situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Region
| Japan |
Condition
Condition
ICU nurse
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create the model of care for situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Qualitative change of recognition and the practice of the nurse before and after the intervention.
Key secondary outcomes
Change of the subjective evaluation of the patient on the change of the nurse's recognition and the practice.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
to make the nurse observing the intentionalness of the patient during daily life care duties and compare the change in the communication with the patient.
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
ICU nurse
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Noguchi |
Organization
Tokyo Medical and Dental University Graduate School of Health Care Siences.
Division name
Critical and Invasive-palliative Care Nursing
Zip code
113-8510
Address
1-5-45 Yushima Bunkyoku Tokyo
TEL
03-3813-6111(7768)
ayakcc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Noguchi |
Organization
Tokyo Medical and Dental University Graduate School of Health Care Siences.
Division name
Critical and Invasive-palliative Care Nursing
Zip code
113-8510
Address
1-5-45 Yushima Bunkyoku Tokyo
TEL
03-3813-6111(7768)
Homepage URL
ayakcc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Faculty of Medicine of Tokyo Medical and DentalUniversity Ethics Committee
Address
1-5-45 Yushima Bunkyoku Tokyo
Tel
03-5803-4085
info.bec@tmd.ac.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
京都府立医科大学附属病院 University Hospital, Kyoto Prefectural University of Medicine
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
org/10.1016/j.iccn.2018.10.006
Publication of results
Published
Result
URL related to results and publications
org/10.1016/j.iccn.2018.10.006
Number of participants that the trial has enrolled
57
Results
After the intervention, the incidence-rate ratios for nurses noticing of patients' intent to communicate were 1.53; there was no change in the frequency of patients' intent to communicate. Further, nurses became more aware of and reflected on their own practices, showed increased interest in co-workers' practices, and considered their actions from patients' perspectives. Patients' satisfaction with nurses' respect for their wishes and dignity also increased.
Results date posted
| 2019 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The intensive care unit of a university hospital.
Participant flow
Action research was applied. Specifically, three interventions promoting awareness of patients' intent to communicate were administered and, pre- and post-intervention, observations of patient-nurse interactions, unstructured interviews with nurses, and a patients' satisfaction survey were conducted.
Adverse events
none
Outcome measures
Nurses' awareness of lightly sedated mechanically ventilated patients' intent to communicate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 13 | Day |
Last modified on
| 2019 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022960
