- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04181294
Time Limited Trials to Reduce Non-Beneficial Intensive Care Unit Treatments
Time Limited Trials to Reduce Non-Beneficial Intensive Care Unit Treatments Among Critically-ill Patients With Advanced Medical Illnesses
Study Overview
Status
Conditions
Detailed Description
Invasive intensive care unit (ICU) treatments for patients with advanced medical illnesses and poor prognoses may prolong suffering with minimal benefit. Unfortunately, the quality of care planning and communication between clinicians and critically-ill patients/families in these situations are highly variable, frequently leading to over-utilization of invasive ICU treatments. Time limited trials (TLTs) are agreements between the clinicians and patients/decision-makers to use certain medical therapies over defined periods of time and evaluate whether patients improve or worsen according to pre-determined clinical parameters. For patients with advanced medical illnesses receiving aggressive ICU treatments, TLTs can promote effective dialogue, develop consensus in decision-making, and set rational boundaries to treatments based on patients' goals of care. The objective of our study is to examine whether a multi-component quality improvement strategy that uses protocoled time limited trials as the default ICU care planning approach for critically-ill patients with advanced medical illnesses will decrease duration and intensity of non-beneficial ICU care without changing hospital mortality.
This study will be conducted in medical ICUs of 3 public teaching hospitals in Los Angeles County. We will train clinicians to use protocol-enhanced TLTs as the default communication and care planning approach in patients with advanced medical illnesses who receive invasive ICU treatments. Eligible patients will be those considered by treating ICU physicians to be at high risk for non-beneficial treatments according to guidelines from the Society of Critical Care Medicine. ICU physicians will be trained to use the TLT protocol through a curriculum of didactic lectures, case discussions, and simulations utilizing actors as family members in role-playing scenarios. Family meetings will be schedule by trained care managers. The improvement strategy will be implemented sequentially in the 3 participating hospitals, and outcomes will be evaluated using a before-after study design.
Key process outcomes will include frequency, timing, and content of family meetings. The primary clinical outcome will be ICU length of stay. Secondary outcomes will include hospital length of stay, days receiving life-sustaining treatments (mechanical ventilation, vasopressors, and renal replacement therapy), number of attempts at cardiopulmonary resuscitation, frequency of invasive ICU procedures, and disposition from hospitalization.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- Los Angeles County-University of Southern California Medical Center
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Sylmar, California, United States, 91342
- Olive View Medical Center
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Torrance, California, United States, 90509
- Harbor Ucla Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients admitted to the medical ICU who are determined on admission by the treating ICU physicians to be at high risk for potentially non-beneficial treatments based on ICU Admission and Triage Guidelines from the Society of Critical Care Medicine
Exclusion Criteria:
- Patients who cannot communicate for themselves and do not have surrogate decision-makers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pre-intervention
Baseline data on patient characteristics and outcomes will be collected for 4 months prior to intervention.
|
Baseline practice of ICU communication and care planning
|
Experimental: Post-intervention
The quality improvement intervention will be conducted sequentially at all 3 medical centers (LAC-USC, Olive View, and Harbor-UCLA Medical Centers).
Data on patient characteristics and outcomes will be collected for 4 months after the intervention
|
Providers will be trained using didactics, focus groups, and simulations using actors as family members.
A TLT protocol and checklist will be used to facilitate family meetings.
A coordinator will schedule family meetings.
Routine feedback sessions will be held with the local champions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU Length of Stay
Time Frame: 4 months
|
ICU LOS will be collected using the electronic medical record
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Length of Stay
Time Frame: 4 months
|
Hospital LOS will be collected using the electronic medical record
|
4 months
|
Days receiving life-sustaining ICU treatments
Time Frame: 4 months
|
Total number of days receiving mechanical ventilation, vasopressor medications, and renal replacement therapy will be collected from the electronic health record
|
4 months
|
Use of invasive ICU procedures
Time Frame: 4 months
|
Total number of central venous or arterial catheterizations, thoracenteses, paracenteses, lumbar punctures, endoscopies, and attempts at cardiopulmonary resuscitation will be collected using the electronic health record
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Key process measure: Family meetings
Time Frame: 4 months
|
A convenience sample of family meetings will be examined to determine the proportion of meetings in which key decision-making components (discussion of medical issues, prognosis, risk/benefit of ICU treatments, patients' values and preferences, clinical markers of improvement, recommendations for next steps) were discussed
|
4 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0311710100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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