- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06211816
Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit
January 16, 2024 updated by: Maebashi Red Cross Hospital
Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit: A Single-center Before and After Study
Burnout among healthcare workers is frequently reported, and one of the factors cited is the stress caused by end-of-life care.
It has been reported that nursing staff experience decreased well-being as a result of being involved in end-of-life care, and this is also true in intensive care units.
This decrease in well-being is said to lead to lower quality of care, poor communication with patients and their families, absenteeism, and high turnover.
Although palliative care interventions such as education and communication tools have been reported to improve the well-being of healthcare professionals involved in end-of-life care, few reports have evaluated the association with burnout.
We investigated whether communication-based palliative interventions in end-of-life care in intensive care units (ICUs) improve the risk of burnout among nurses working in ICUs.
Study Overview
Detailed Description
A before-and-after study was conducted in a single hospital to evaluate burnout risk and satisfaction with end-of-life situations in 2022 (phase 1) and 2023 (phase 2).
The Japanese version of the Burnout Scale was used to assess the risk of burnout, and the QODD (Quality of Dying and Death) was used to assess nurse satisfaction.
All nurses who agreed to participate received the questionnaire in a sealed envelope, completed it, and returned it anonymously to the principal investigator.
Data from those who declined to participate were not recorded.
During the first and second phases, an intensive communication strategy on end-of-life practice was implemented based on the framework developed at the International Delphi Conference.
The following data were recorded for all participating nurses: age, gender, marital status, years of practice since certification, and years of critical care experience; the following data on ICU status were also collected from the electronic system: total number of patients, length of ICU stay, ICU mortality rate, in-hospital mortality rate, ICU admission APACHE-II score, SOFA score at ICU admission, and medical costs at ICU admission.
Continuous variables without normal distribution are shown as median and interquartile range.
Categorical data were summarized numerically or as percentages.
In univariate analyses, Mann-Whitney's U test was used to compare continuous variables and Fisher's exact test to compare categorical variables.
Data were assumed to be missing at random, and no imputation or interpolation of missing values was performed.
Statistical tests were two-tailed and statistical significance was set at p<0.05.
All statistical analyses were performed using EZR (R Foundation for Statistical Computing, Vienna, Austria), a graphical user interface for R. The study was approved by the Maebashi Red Cross Hospital Ethics Committee (ID: 2022-47), which waived the requirement for informed consent from patients and their relatives, given the retrospective and observational nature of the study.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gunma
-
Maebashi, Gunma, Japan
- Maebashi Redcross hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Registered nurses working in our ICU
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Nurse prior to intervention
|
an intensive communication strategy on end-of-life practice was implemented, based on a framework developed by the International Delphi Conference.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Japanese Quality of Dying and Death (QODD) in ICU
Time Frame: Approximately one month
|
The Japanese Quality of Dying and Death (QODD) in ICU consists of six items, each of which is rated on a scale of 0 to 10, with higher scores indicating higher quality of death.
It is based on the U.S. Intensive Care Unit version of the Quality of Dying and Death (ICU-QODD) and was adapted to Japanese culture, and its validation has been confirmed.
|
Approximately one month
|
|
The Japanese Burnout Scale
Time Frame: Approximately one month
|
The Japanese Burnout Scale consists of 17 items, each with a score of 1-5, with higher scores indicating stronger burnout symptoms.
It assesses subjects' burnout symptoms and is based on the Massachusetts Burnout Inventory.
The scale was developed for the Japanese culture based on the Massluck Burnout Inventory, and its validation has been verified.
|
Approximately one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The medical costs in ICU
Time Frame: Approximately one month
|
Calculated for the total medical costs incurred in the ICU
|
Approximately one month
|
|
The length of ICU stay
Time Frame: Approximately one month
|
Calculated as the average number of days per stay per patient
|
Approximately one month
|
|
Mortality at ICU
Time Frame: Approximately one month
|
Approximately one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Quenot JP, Rigaud JP, Prin S, Barbar S, Pavon A, Hamet M, Jacquiot N, Blettery B, Herve C, Charles PE, Moutel G. Suffering among carers working in critical care can be reduced by an intensive communication strategy on end-of-life practices. Intensive Care Med. 2012 Jan;38(1):55-61. doi: 10.1007/s00134-011-2413-z. Epub 2011 Nov 30.
- Kerckhoffs MC, Senekal J, van Dijk D, Artigas A, Butler J, Michalsen A, van Mol MMC, Moreno R, Pais da Silva F, Picetti E, Povoa P, Robertsen A, van Delden JJM. Framework to Support the Process of Decision-Making on Life-Sustaining Treatments in the ICU: Results of a Delphi Study. Crit Care Med. 2020 May;48(5):645-653. doi: 10.1097/CCM.0000000000004221.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
November 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
December 7, 2023
First Submitted That Met QC Criteria
January 16, 2024
First Posted (Estimated)
January 18, 2024
Study Record Updates
Last Update Posted (Estimated)
January 18, 2024
Last Update Submitted That Met QC Criteria
January 16, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000001 (Other Grant/Funding Number: New York City Mayors Office Community Mental Health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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