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

NCT ID: NCT04181294

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-12-31

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.

Conditions

Critical Illness; Communication

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pre-intervention

Baseline data on patient characteristics and outcomes will be collected for 4 months prior to intervention.

Group Type: EXPERIMENTAL

Usual practice

Intervention Type: BEHAVIORAL

Baseline practice of ICU communication and care planning

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

Family 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.

Intervention Type: BEHAVIORAL

Usual practice

Baseline practice of ICU communication and care planning

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Los Angeles Department of Health Services

UNKNOWN

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dong Chang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

United States

References

Chang DW, Neville TH, Parrish J, Ewing L, Rico C, Jara L, Sim D, Tseng CH, van Zyl C, Storms AD, Kamangar N, Liebler JM, Lee MM, Yee HF Jr. Evaluation of Time-Limited Trials Among Critically Ill Patients With Advanced Medical Illnesses and Reduction of Nonbeneficial ICU Treatments. JAMA Intern Med. 2021 Jun 1;181(6):786-794. doi: 10.1001/jamainternmed.2021.1000.

Reference Type: DERIVED

PMID: 33843946 (View on PubMed)

Other Identifiers

0311710100

Identifier Type: -

Identifier Source: org_study_id