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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James (Wes) McGaughey, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00996814
First received: September 14, 2009
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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 Intervention
Intensive Care Unit Days
Behavioral: Proactive Ethics Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Proactive Ethics Intervention to Improve ICU Care

Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Length of Stay in Days [ Time Frame: Date and time of admission to date and time of discharge (in 24 hour periods) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Provider satisfaction [ Time Frame: Survey administered daily while patient in under their care and 48 hours after their patient's discharge ] [ Designated as safety issue: No ]

Enrollment: 386
Study Start Date: October 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996814

Locations
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
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

No publications provided by California Pacific Medical Center Research Institute

Additional 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
Study First Received: September 14, 2009
Last Updated: January 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by California Pacific Medical Center Research Institute:
Bioethics

ClinicalTrials.gov processed this record on July 29, 2014