Intensive Care Unit DaysPEINCT00996814
Proactive Ethics Intervention to Improve Intensive Care Unit (ICU) Care
A study testing Proactive Ethics Intervention in people with Intensive Care Unit Days, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Days
- What is being tested?
- Proactive Ethics Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (over 18 years of age)
- Under treatment for five days or more in the ICU
Who cannot join
- Under the age of 18
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
California Pacific Medical Center
San Francisco, California, 94115
About this study
Official title: 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.
- Conditions
- Intensive Care Unit Days
- Being tested
- Proactive Ethics Intervention
- Keywords
- Bioethics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive Ethics InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Proactive Ethics Intervention | Experimental | These patients have an ethics consultant involved in their care beginning on the fifth day of treatment in the ICU Receives: Behavioral: Proactive Ethics Intervention |
| Usual Care | No intervention | These patients receive usual care in the ICU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay in Days
Measured: Date and time of admission to date and time of discharge (in 24 hour periods)
Secondary outcomes (2)
Patient Satisfaction
Measured: Survey administered every two days while patient is in the ICU and a final survey one month after discharge from the hospital
Provider satisfaction
Measured: Survey administered daily while patient in under their care and 48 hours after their patient's discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit DaysStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James (Wes) McGaughey, California Pacific Medical Center Research Institute
- Investigators
- William S Andereck, MD, Principal investigator, California Pacific Medical CenterLawrence J Schneiderman, MD, Principal investigator, University of California, San DiegoJ. Westly McGaughey, B.A., Principal investigator, California Pacific Medical CenterAlbert R. Jonsen, Ph.D., Principal investigator, California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996814
- Sponsor's protocol ID
- 26.111EXP
- Acronym
- PEI
- Status last verified
- Jan 2012
- First submitted
- 14 Sep 2009
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24201177
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Ethics Intervention to Improve ICU Care
- ClinicalTrials.gov ID
- NCT00996814
- Acronym / sponsor ID
- PEI / 26.111EXP
- Conditions
- Intensive Care Unit Days
- Keywords
- Bioethics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive Ethics Intervention | Experimental | Behavioral: Proactive Ethics InterventionThese patients have an ethics consultant involved in their care beginning on the fifth day of treatment in the ICU |
| Usual Care | No intervention | –These patients receive usual care in the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (over 18 years of age)
- Under treatment for five days or more in the ICU
Key exclusion criteria (2 listed)
- Under the age of 18
- Non-English Speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive Ethics InterventionThe 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. | Behavioural | Proactive Ethics Intervention |
Primary outcome
Length of Stay in Days
Time frame: Date and time of admission to date and time of discharge (in 24 hour periods)
2 secondary outcomes
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
Provider satisfaction
Time frame: Survey administered daily while patient in under their care and 48 hours after their patient's discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
- Derived from this study: PubMed 24201177Andereck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William S Andereck, MD principal investigator
California Pacific Medical Center
Lawrence J Schneiderman, MD principal investigator
University of California, San Diego
J. Westly McGaughey, B.A. principal investigator
California Pacific Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Ethics Intervention in people with Intensive Care Unit Days, run by California Pacific Medical Center Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay in Days (time frame: Date and time of admission to date and time of discharge (in 24 hour periods)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00996814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2012.