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

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 Overview

• Status: Enrolling by invitation
• Conditions: Proactive Clinical Ethics Consultation; the Critically Ill
• Intervention / Treatment: Other: proactive clinical ethics consultation

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: proactive clinical ethics consultation group	Other: 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.
No Intervention: routine care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital length of stay	days that patient in the hospital	through study completion, an average of 2 years
ICU length of stay	days that patient in the intensive care unit	through study completion, an average of 2 years
use of life-sustaining treatment	days of the use of life-sustaining treatment	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
family or surrogate satisfaction questionnaire	family or surrogate satisfaction for ethics consultation	within 4 weeks after patient discharge
family or surrogate satisfaction questionnaire	family or surrogate satisfaction for patient care	within 4 weeks after patient discharge
healthcare provider satisfaction questionnaire	healthcare provider satisfaction for ethics consultation	within 2 weeks after patient discharge

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2014
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: critically ill; end-of-life care; interprofessional education; proactive clinical ethics consultation; interprofessional practicethe
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: KMUH-IRB-20130379

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No