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)

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name