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

Proactive Ethics Intervention to Improve ICU Care

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 Overview

• Status: Completed
• Conditions: Intensive Care Unit Days
• Intervention / Treatment: Behavioral: Proactive Ethics Intervention

• Study Type: Interventional
• Enrollment (Actual): 386
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of Stay in Days	Date and time of admission to date and time of discharge (in 24 hour periods)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Andereck WS, McGaughey JW, Schneiderman LJ, Jonsen AR. Seeking to reduce nonbeneficial treatment in the ICU: an exploratory trial of proactive ethics intervention*. Crit Care Med. 2014 Apr;42(4):824-30. doi: 10.1097/CCM.0000000000000034.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 14, 2009
• First Submitted That Met QC Criteria: October 15, 2009
• First Posted (Estimate): October 16, 2009

Study Record Updates

• Last Update Posted (Estimate): January 11, 2012
• Last Update Submitted That Met QC Criteria: January 10, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Bioethics
• Other Study ID Numbers: 26.111EXP