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

Sponsor
California Pacific Medical Center Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00996814
Collaborator
(none)
386
1
2
28.1
13.8

Study Details

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 Phase
  • Behavioral: Proactive Ethics Intervention
N/A

Study Design

Study Type:
Interventional
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 :
Oct 1, 2007
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Feb 1, 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 [Date and time of admission to date and time of discharge (in 24 hour periods)]

Secondary Outcome Measures

  1. Patient Satisfaction [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 [Survey administered daily while patient in under their care and 48 hours after their patient's discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James (Wes) McGaughey, Research Analyst, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00996814
Other Study ID Numbers:
  • 26.111EXP
First Posted:
Oct 16, 2009
Last Update Posted:
Jan 11, 2012
Last Verified:
Jan 1, 2012
Keywords provided by James (Wes) McGaughey, Research Analyst, California Pacific Medical Center Research Institute

Study Results

No Results Posted as of Jan 11, 2012