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

NCT00996814 | Completed

• 1 other identifier: 26.111EXP
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Days

Keywords

Bioethics

Outcome Measures

Primary Outcomes (1)

• Length of Stay in Days

  Date and time of admission to date and time of discharge (in 24 hour periods)

Secondary Outcomes (2)

• 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

Study Arms (2)

Proactive Ethics Intervention

EXPERIMENTAL

These patients have an ethics consultant involved in their care beginning on the fifth day of treatment in the ICU

Behavioral: Proactive Ethics Intervention

Usual Care

NO INTERVENTION

These patients receive usual care in the ICU.

Interventions

Proactive Ethics Intervention BEHAVIORAL

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.

Proactive Ethics Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (over 18 years of age)
• Under treatment for five days or more in the ICU

You may not qualify if:

• Under the age of 18
• Non-English Speaking

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead

Study Sites (1)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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.

  PMID: 24201177 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Analyst

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: October 16, 2009
• Study Start: October 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

US (1)