The Effect of Proactive Clinical Ethics Consultations on End-of-life Care of the Critically Ill in the Intensive Care Settings

NCT ID: NCT04926610

Last Updated: 2022-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-07

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Proactive Clinical Ethics Consultation the Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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proactive clinical ethics consultation group

Group Type EXPERIMENTAL

proactive clinical ethics consultation

Intervention Type OTHER

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.

routine care group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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proactive clinical ethics consultation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Medical staff involved in caring for terminal patients
2. Cases of active clinical ethics consultation in our hospital

Exclusion Criteria

1. Medical staff who refuse to participate in the study or are unable to understand the way the study is conducted
2. Cases of refusing to participate in the research or unable to understand the way the research is conducted.
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Medical University Chung-Ho hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 40753248 (View on PubMed)

Other Identifiers

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KMUH-IRB-20130379

Identifier Type: -

Identifier Source: org_study_id

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