Proactive Clinical Ethics ConsultationNCT04926610
The Effect of Proactive Clinical Ethics Consultations on End-of-life Care of the Critically Ill in the Intensive Care Settings
A study testing proactive clinical ethics consultation in people with Proactive Clinical Ethics Consultation and the Critically Ill, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Study objective: This study is planning to explore factors predicting the use of life-sustaining treatment, develop the screening criteria of proactive clinical ethics consultations, the effect of proactive clinical ethics consultations and interprofessional practice on end-of-life care of the critically ill in the… Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Proactive Clinical Ethics Consultation, the Critically Ill
- What is being tested?
- proactive clinical ethics consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Apr 2014to 31 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical staff involved in caring for terminal patients
- Cases of active clinical ethics consultation in our hospital
Who cannot join
- Medical staff who refuse to participate in the study or are unable to understand the way the study is conducted
- Cases of refusing to participate in the research or unable to understand the way the research is conducted.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho hospital
Kaohsiung City, 807
About this study
Study objective: This study is planning to explore factors predicting the use of life-sustaining treatment, develop the screening criteria of proactive clinical ethics consultations, the effect of proactive clinical ethics consultations and interprofessional practice on end-of-life care of the critically ill in the intensive care settings, and develop the competency for trainees by interprofessional education.
Methods: Data will be collected prospectively. Data between January 2013 and April 2014 was collected from hospital electronic record and ethics consultation document. All data will be analyzed for patients dying in the intensive care settings during the first stage of the study. Factors predicting the use of life-sustaining treatment will be determined. The Delphi technique will be applied to secure a consensus among the panel of experts chosen to help develop the screening criteria of proactive ethics consultations. A prospective randomized controlled trial will be conducted during the second stage of the study on a convenience sample of adult critical ill patients in the intensive care settings. Patients will randomize to the intervention group receive proactive ethics consultations. The control group will undergo routine intensive care, receiving clinical ethics consultations as requested by healthcare team, patients or family. All participants will be asked to complete a questionnaire rating their satisfaction with the healthcare process and consultations if conducted. Mean length of stay and the duration of the use of life-sustaining treatment will be compared between two groups. Secondary outcomes will include the proportion of satisfied families and healthcare team members. The interprofessional education with the core curriculum and case scenario for simulation will be developed, implement, and evaluated.
- Being tested
- proactive clinical ethics consultation
- Keywords
- proactive clinical ethics consultation, critically ill, end-of-life care, interprofessional practicethe, interprofessional education
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proactive clinical ethics consultationOther
When the patients meet the initiation criteria of this study, the patients were randomly assigned to the intervention group (providing proactive clinical ethics consultation) and the routine care group (no proactive clinical ethics consultation) after obtaining the consent of the subjects.
| Study group | Role | What they receive |
|---|---|---|
| proactive clinical ethics consultation group | Experimental | Not described Receives: Other: proactive clinical ethics consultation |
| routine care group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital length of stay
days that patient in the hospital
Measured: through study completion, an average of 2 years
ICU length of stay
days that patient in the intensive care unit
Measured: through study completion, an average of 2 years
use of life-sustaining treatment
days of the use of life-sustaining treatment
Measured: through study completion, an average of 2 years
Secondary outcomes (3)
family or surrogate satisfaction questionnaire
family or surrogate satisfaction for ethics consultation
Measured: within 4 weeks after patient discharge
family or surrogate satisfaction questionnaire
family or surrogate satisfaction for patient care
Measured: within 4 weeks after patient discharge
healthcare provider satisfaction questionnaire
healthcare provider satisfaction for ethics consultation
Measured: within 2 weeks after patient discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start7 Apr 2014
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proactive Clinical Ethics ConsultationStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926610
- Sponsor's protocol ID
- KMUH-IRB-20130379
- Status last verified
- Sep 2022
- First submitted
- 21 Feb 2021
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin YK, Chen CW, Yeh YS, Lin CJ, Huang YW, Lin YC, Sheu CC. Impacts of mandatory clinical ethics consultation on resource utilization and ethical conflicts in critically ill patients: a comparison between medical and surgical intensive care units. BMC Med Ethics. 2025 Aug 2;26(1):110. doi: 10.1186/s12910-025-01268-4.
PubMed 40753248
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proactive Clinical Ethics Consultations on End-of-life Care of the Critically Ill in the Intensive Care Settings
- ClinicalTrials.gov ID
- NCT04926610
- Acronym / sponsor ID
- KMUH-IRB-20130379
- Keywords
- proactive clinical ethics consultation, critically ill, end-of-life care, interprofessional practicethe, interprofessional education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 7 Apr 2014 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Jun 2021 (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.
Study objective: This study is planning to explore factors predicting the use of life-sustaining treatment, develop the screening criteria of proactive clinical ethics consultations, the effect of proactive clinical ethics consultations and interprofessional practice on end-of-life care of the critically ill in the intensive care settings, and develop the competency for trainees by interprofessional education.
Methods: Data will be collected prospectively. Data between January 2013 and April 2014 was collected from hospital electronic record and ethics consultation document. All data will be analyzed for patients dying in the intensive care settings during the first stage of the study. Factors predicting the use of life-sustaining treatment will be determined. The Delphi technique will be applied to secure a consensus among the panel of experts chosen to help develop the screening criteria of proactive ethics consultations. A prospective randomized controlled trial will be conducted during the second stage of the study on a convenience sample of adult critical ill patients in the intensive care settings. Patients will randomize to the intervention group receive proactive ethics consultations. The control group will undergo routine intensive care, receiving clinical ethics consultations as requested by healthcare team, patients or family. All participants will be asked to complete a questionnaire rating their satisfaction with the healthcare process and consultations if conducted. Mean length of stay and the duration of the use of life-sustaining treatment will be compared between two groups. Secondary outcomes will include the proportion of satisfied families and healthcare team members. The interprofessional education with the core curriculum and case scenario for simulation will be developed, implement, and evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proactive clinical ethics consultation group | Experimental | Other: proactive clinical ethics consultation |
| routine care group | No intervention | – |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medical staff involved in caring for terminal patients
- Cases of active clinical ethics consultation in our hospital
Key exclusion criteria (2 listed)
- Medical staff who refuse to participate in the study or are unable to understand the way the study is conducted
- Cases of refusing to participate in the research or unable to understand the way the research is conducted.
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 |
|---|---|---|
| proactive clinical ethics consultationWhen the patients meet the initiation criteria of this study, the patients were randomly assigned to the intervention group (providing proactive clinical ethics consultation) and the routine care group (no proactive clinical ethics consultation) after obtaining the consent of the subjects. | Other | proactive clinical ethics consultation group |
Primary outcome
hospital length of stay
Time frame: through study completion, an average of 2 years
days that patient in the hospital
ICU length of stay
Time frame: through study completion, an average of 2 years
days that patient in the intensive care unit
use of life-sustaining treatment
Time frame: through study completion, an average of 2 years
days of the use of life-sustaining treatment
3 secondary outcomes
family or surrogate satisfaction questionnaire
Time frame: within 4 weeks after patient discharge
family or surrogate satisfaction questionnaire
Time frame: within 4 weeks after patient discharge
healthcare provider satisfaction questionnaire
Time frame: within 2 weeks after patient discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Derived from this study: PubMed 40753248Lin YK, Chen CW, Yeh YS, Lin CJ, Huang YW, Lin YC, Sheu CC. Impacts of mandatory clinical ethics consultation on resource utilization and ethical conflicts in critically ill patients: a comparison between medical and surgical intensive care units. BMC Med Ethics. 2025 Aug 2;26(1):110. doi: 10.1186/s12910-025-01268-4.
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 proactive clinical ethics consultation in people with Proactive Clinical Ethics Consultation and the Critically Ill, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. 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 Taiwan. 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?
Results are not available in the source record.
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?
hospital length of stay (time frame: through study completion, an average of 2 years). The study lists 3 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 NCT04926610, which also lists 1 linked publication.
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 8 Sep 2022.