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Completed

NCT Number: NCT00996814

Proactive Ethics Intervention to Improve Intensive Care Unit (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.

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Key information

Conditions

Intensive Care Unit Days

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Pacific Medical Center

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Length of Stay in Days

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

Secondary outcomes

  1. 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

  2. Provider satisfaction

    Time frame: Survey administered daily while patient in under their care and 48 hours after their patient's discharge

Sponsors and collaborators

Lead sponsor

California Pacific Medical Center Research Institute

Other

Registry information

Official study title

Proactive Ethics Intervention to Improve ICU Care

Acronym: PEI

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 16, 2009
Registry last updated
Jan 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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