Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit

Palliative Care Clinical Trial

Official title:

Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit: A Single-center Before and After Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06211816
• Other study ID #: 000001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Maebashi Red Cross Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Registered nurses working in our ICU

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Death
• Palliative Care

Intervention

Other:
• communication strategy
an intensive communication strategy on end-of-life practice was implemented, based on a framework developed by the International Delphi Conference.

Locations

Country	Name	City	State
Japan	Maebashi Redcross hospital	Maebashi	Gunma

Sponsors (1)

Lead Sponsor	Collaborator
Maebashi Red Cross Hospital

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Japanese Quality of Dying and Death (QODD) in ICU	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
Primary	The Japanese Burnout Scale	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	The medical costs in ICU	Calculated for the total medical costs incurred in the ICU	Approximately one month
Secondary	The length of ICU stay	Calculated as the average number of days per stay per patient	Approximately one month
Secondary	Mortality at ICU		Approximately one month