Clinical trial NCT00996814: Proactive Ethics Intervention to Improve Intensive Care Unit (ICU) Care
Official title: Proactive Ethics Intervention to Improve ICU Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Days
Keywords: Bioethics
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary aim of the study is to demonstrate the value of a preemptive approach to ethics consultation in an ICU. The investigators hope to answer the question: Will proactive ethics interventions by a skilled and experienced ethicist, participating in treatment discussions with physicians and nurses, as well as discussions with patients/surrogates, improve the quality of ICU care experienced by patients requiring prolonged treatment in the ICU (5 days or longer) by increasing their perceived quality of care and reducing the length of stay in the ICU by non-survivors?

The study is a randomized trial of the use of an ethics consultant to address latent or manifest ethical issues in patients who remain in the ICU for five days or more, as compared to usual care. The investigators are testing the hypothesis that expanding the role of ethics consultations in the ICU to make them proactive will improve the process and outcomes of patient care by shortening the length of stay in non-survivors, and reducing suffering and unwanted and/or unnecessary aggressive treatments.


Eligibility criteria: Inclusion Criteria:

* Adult (over 18 years of age)
* Under treatment for five days or more in the ICU

Exclusion Criteria:

* Under the age of 18
* Non-English Speaking

Primary outcomes:
measure: Length of Stay in Days
timeFrame: Date and time of admission to date and time of discharge (in 24 hour periods)
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Survey administered every two days while patient is in the ICU and a final survey one month after discharge from the hospital
measure: Provider satisfaction
timeFrame: Survey administered daily while patient in under their care and 48 hours after their patient's discharge
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
Study officials:
affiliation: California Pacific Medical Center
name: William S Andereck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Lawrence J Schneiderman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: California Pacific Medical Center
name: J. Westly McGaughey, B.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: California Pacific Medical Center
name: Albert R. Jonsen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andereck WS, McGaughey JW, Schneiderman LJ, Jonsen AR. Seeking to reduce nonbeneficial treatment in the ICU: an exploratory trial of proactive ethics intervention*. Crit Care Med. 2014 Apr;42(4):824-30. doi: 10.1097/CCM.0000000000000034.