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

NCT00996814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2012-01-11

No results posted yet for this study

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.

Conditions

  • Intensive Care Unit Days

Interventions

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.

Sponsors & Collaborators

  • California Pacific Medical Center Research Institute

    lead OTHER

Principal Investigators

  • William S Andereck, MD · California Pacific Medical Center

  • Lawrence J Schneiderman, MD · University of California, San Diego

  • J. Westly McGaughey, B.A. · California Pacific Medical Center

  • Albert R. Jonsen, Ph.D. · California Pacific Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00996814 on ClinicalTrials.gov