Time Limited Trials to Reduce Non-Beneficial Intensive Care Unit Treatments

Not Applicable

Completed

• Conditions: Critical Illness; Communication

• Registration Number: NCT04181294
• Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Brief Summary

Overutilization of intensive care unit (ICU) treatments among patients with advanced medical illnesses and poor prognosis places them at risk for prolonged suffering with minimal anticipated benefit. Improving communication and shared decision-making between providers and patients/family members represents an opportunity to reduce potentially non-beneficial treatments. Time limited trials (TLTs) are agreements between clinicians and patients/surrogate decision-makers to use medical therapies over a defined period of time to observe if patients improve or deteriorate according to agreed-upon clinical outcomes. The objective of this project is to examine whether a quality improvement intervention that uses protocoled time limited trials as the default ICU communication/care planning strategy for patients with advanced medical illnesses will decrease the duration and intensity of non-beneficial ICU treatments without changing hospital mortality.

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 Timeline

• Study Start: 2017-08-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-29
• Primary Completion: 2019-12-23
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
ICU Length of Stay	4 months	ICU LOS will be collected using the electronic medical record

Secondary Outcome Measures

Name	Time	Method
Use of invasive ICU procedures	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
Days receiving life-sustaining ICU treatments	4 months	Total number of days receiving mechanical ventilation, vasopressor medications, and renal replacement therapy will be collected from the electronic health record
Hospital Length of Stay	4 months	Hospital LOS will be collected using the electronic medical record

Trial Locations

Locations (3)

Los Angeles County-University of Southern California Medical Center; 🇺🇸 Los Angeles, California, United States

Olive View Medical Center; 🇺🇸 Sylmar, California, United States

Harbor UCLA Medical Center; 🇺🇸 Torrance, California, United States