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Proactive Ethics Intervention to Improve Intensive Care Unit (ICU) Care (PEI)

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ClinicalTrials.gov Identifier: NCT00996814
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Intensive Care Unit Days Behavioral: Proactive Ethics Intervention

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Proactive Ethics Intervention to Improve ICU Care
Study Start Date : October 2007
Primary Completion Date : February 2010
Study Completion Date : February 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: Proactive Ethics Intervention
These patients have an ethics consultant involved in their care beginning on the fifth day of treatment in the ICU
Behavioral: Proactive Ethics Intervention
The ethicist will: 1) meet with the patient or surrogate to assess the case and the decision-making capacity of the patient; 2) make an ethical diagnosis, framing the issues in easily understood ethical terms with the involved parties; 3) recommend the next steps, including measures to improve communication. The ethicist will help to articulate consensus or disagreement and either facilitate implementing the consensus or facilitate ways to address and resolve disagreements; 4) document the consultation in the patient's medical record, identifying the ethical issues identified, the steps taken to address those issues, the options and ethical rationales considered, the outcome and the future plan; 5) follow-up to provide ongoing support and record a follow up progress note in the chart; and 6) participate in evaluation.
No Intervention: Usual Care
These patients receive usual care in the ICU.

Outcome Measures

Primary Outcome Measures :
  1. Length of Stay in Days [ Time Frame: Date and time of admission to date and time of discharge (in 24 hour periods) ]

Secondary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: Survey administered every two days while patient is in the ICU and a final survey one month after discharge from the hospital ]
  2. Provider satisfaction [ Time Frame: Survey administered daily while patient in under their care and 48 hours after their patient's discharge ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996814

United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Principal Investigator: William S Andereck, MD California Pacific Medical Center
Principal Investigator: Lawrence J Schneiderman, MD University of California, San Diego
Principal Investigator: J. Westly McGaughey, B.A. California Pacific Medical Center
Principal Investigator: Albert R. Jonsen, Ph.D. California Pacific Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James (Wes) McGaughey, Research Analyst, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00996814     History of Changes
Other Study ID Numbers: 26.111EXP
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by James (Wes) McGaughey, California Pacific Medical Center Research Institute: