The Effect of Proactive Clinical Ethics Consultations on End-of-life Care of the Critically Ill in the Intensive Care Settings
Primary Purpose
Proactive Clinical Ethics Consultation, the Critically Ill
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
proactive clinical ethics consultation
Sponsored by
About this trial
This is an interventional health services research trial for Proactive Clinical Ethics Consultation focused on measuring proactive clinical ethics consultation, critically ill, end-of-life care, interprofessional practicethe, interprofessional education
Eligibility Criteria
Inclusion Criteria:
- Medical staff involved in caring for terminal patients
- Cases of active clinical ethics consultation in our hospital
Exclusion Criteria:
- 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.
Sites / Locations
- Kaohsiung Medical University Chung-Ho hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
proactive clinical ethics consultation group
routine care group
Arm Description
Outcomes
Primary Outcome Measures
hospital length of stay
days that patient in the hospital
ICU length of stay
days that patient in the intensive care unit
use of life-sustaining treatment
days of the use of life-sustaining treatment
Secondary Outcome Measures
family or surrogate satisfaction questionnaire
family or surrogate satisfaction for ethics consultation
family or surrogate satisfaction questionnaire
family or surrogate satisfaction for patient care
healthcare provider satisfaction questionnaire
healthcare provider satisfaction for ethics consultation
Full Information
NCT ID
NCT04926610
First Posted
February 21, 2021
Last Updated
September 4, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04926610
Brief Title
The Effect of Proactive Clinical Ethics Consultations on End-of-life Care of the Critically Ill in the Intensive Care Settings
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 7, 2014 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proactive Clinical Ethics Consultation, the Critically Ill
Keywords
proactive clinical ethics consultation, critically ill, end-of-life care, interprofessional practicethe, interprofessional education
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
proactive clinical ethics consultation group
Arm Type
Experimental
Arm Title
routine care group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
proactive clinical ethics consultation
Intervention Description
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.
Primary Outcome Measure Information:
Title
hospital length of stay
Description
days that patient in the hospital
Time Frame
through study completion, an average of 2 years
Title
ICU length of stay
Description
days that patient in the intensive care unit
Time Frame
through study completion, an average of 2 years
Title
use of life-sustaining treatment
Description
days of the use of life-sustaining treatment
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
family or surrogate satisfaction questionnaire
Description
family or surrogate satisfaction for ethics consultation
Time Frame
within 4 weeks after patient discharge
Title
family or surrogate satisfaction questionnaire
Description
family or surrogate satisfaction for patient care
Time Frame
within 4 weeks after patient discharge
Title
healthcare provider satisfaction questionnaire
Description
healthcare provider satisfaction for ethics consultation
Time Frame
within 2 weeks after patient discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medical staff involved in caring for terminal patients
Cases of active clinical ethics consultation in our hospital
Exclusion Criteria:
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.
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Effect of Proactive Clinical Ethics Consultations on End-of-life Care of the Critically Ill in the Intensive Care Settings
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