Clinical trial NCT04926610: The Effect of Proactive Clinical Ethics Consultations on End-of-life Care of the Critically Ill in the Intensive Care Settings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Proactive Clinical Ethics Consultation
the Critically Ill
Keywords: proactive clinical ethics consultation
critically ill
end-of-life care
interprofessional practicethe
interprofessional education
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 224
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: hospital length of stay
timeFrame: through study completion, an average of 2 years
measure: ICU length of stay
timeFrame: through study completion, an average of 2 years
measure: use of life-sustaining treatment
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: family or surrogate satisfaction questionnaire
timeFrame: within 4 weeks after patient discharge
measure: family or surrogate satisfaction questionnaire
timeFrame: within 4 weeks after patient discharge
measure: healthcare provider satisfaction questionnaire
timeFrame: within 2 weeks after patient discharge
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho hospital
Study officials:
References: