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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04181294
Enrollment
209
Registered
2019-11-29
Start date
2017-08-01
Completion date
2019-12-31
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication, Critical Illness

Keywords

Palliative Care, Medical Futility, Intensive Care

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.

Interventions

BEHAVIORALFamily meetings using time limited trials as default ICU communication and care planning approach

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.

BEHAVIORALUsual practice

Baseline practice of ICU communication and care planning

Sponsors

Los Angeles Department of Health Services
CollaboratorUNKNOWN
University of California, Los Angeles
CollaboratorOTHER
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Pre- and post study design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ICU Length of Stay4 monthsICU LOS will be collected using the electronic medical record

Secondary

MeasureTime frameDescription
Hospital Length of Stay4 monthsHospital LOS will be collected using the electronic medical record
Days receiving life-sustaining ICU treatments4 monthsTotal number of days receiving mechanical ventilation, vasopressor medications, and renal replacement therapy will be collected from the electronic health record
Use of invasive ICU procedures4 monthsTotal 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

Other

MeasureTime frameDescription
Key process measure: Family meetings4 monthsA 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026