Proactive Ethics Intervention to Improve Intensive Care Unit (ICU) Care (PEI)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
|Official Title:||Proactive Ethics Intervention to Improve ICU Care|
- Length of Stay in Days [ Time Frame: Date and time of admission to date and time of discharge (in 24 hour periods) ]
- 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 ]
- Provider satisfaction [ Time Frame: Survey administered daily while patient in under their care and 48 hours after their patient's discharge ]
|Study Start Date:||October 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996814
|United States, California|
|California Pacific Medical Center|
|San Francisco, California, United States, 94115|
|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|