Palliative CareNCT06211816
Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit
A study testing communication strategy in people with Palliative Care, run by Maebashi Red Cross Hospital at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- What is being tested?
- communication strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteJapan
- Study dates
- 1 Sep 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Registered nurses working in our ICU
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Palliative Care
- Being tested
- communication strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication strategyOther
an intensive communication strategy on end-of-life practice was implemented, based on a framework developed by the International Delphi Conference.
| Study group | Role | What they receive |
|---|---|---|
| Nurse prior to intervention | Other | Not described Receives: Other: communication strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately one month
Secondary outcomes (3)
The medical costs in ICU
Calculated for the total medical costs incurred in the ICU
Measured: Approximately one month
The length of ICU stay
Calculated as the average number of days per stay per patient
Measured: Approximately one month
Mortality at ICU
Measured: Approximately one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Sep 2022
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maebashi Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211816
- Sponsor's protocol ID
- 000001
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 22127481Kerckhoffs 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.
PubMed 32310619
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit: A Single-center Before and After Study
- ClinicalTrials.gov ID
- NCT06211816
- Acronym / sponsor ID
- 000001
- Conditions
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Maebashi Red Cross HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurse prior to intervention | Other | Other: communication strategy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Registered nurses working in our ICU
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| communication strategyan intensive communication strategy on end-of-life practice was implemented, based on a framework developed by the International Delphi Conference. | Other | Nurse prior to intervention |
Primary outcome
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.
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.
3 secondary outcomes
The medical costs in ICU
Time frame: Approximately one month
The length of ICU stay
Time frame: Approximately one month
Mortality at ICU
Time frame: Approximately one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Background: PubMed 22127481Quenot 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.
- Background: PubMed 32310619Kerckhoffs 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication strategy in people with Palliative Care, run by Maebashi Red Cross Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Japanese Quality of Dying and Death (QODD) in ICU (time frame: Approximately one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06211816, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.