NCT06211816

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

December 7, 2023

Last Update Submit

January 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • The medical costs in ICU

    Approximately one month

  • The length of ICU stay

    Approximately one month

  • Mortality at ICU

    Approximately one month

Study Arms (1)

Nurse prior to intervention

OTHER
Other: communication strategy

Interventions

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

Nurse prior to intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Registered nurses working in our ICU

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maebashi Redcross hospital

Maebashi, Gunma, Japan

Location

Related Publications (2)

  • 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.

    PMID: 22127481BACKGROUND
  • 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.

    PMID: 32310619BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

January 18, 2024

Study Start

September 1, 2022

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations