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

NCT04181294 | Completed

• 1 other identifier: 0311710100
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 3

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.

Conditions

Critical Illness; Communication

Keywords

Palliative Care; Medical Futility; Intensive Care

Outcome Measures

Primary Outcomes (1)

• ICU Length of Stay

  ICU LOS will be collected using the electronic medical record

  4 months

Secondary Outcomes (3)

• Hospital Length of Stay

  4 months

• Days receiving life-sustaining ICU treatments

  4 months

• Use of invasive ICU procedures

  4 months

Other Outcomes (1)

• Key process measure: Family meetings

  4 months

Study Arms (2)

Pre-intervention

EXPERIMENTAL

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

Behavioral: Usual practice

Post-intervention

EXPERIMENTAL

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

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

Interventions

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

Post-intervention

Usual practice BEHAVIORAL

Baseline practice of ICU communication and care planning

Pre-intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who cannot communicate for themselves and do not have surrogate decision-makers

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• Los Angeles Department of Health Services: collaborator
• University of California, Los Angeles: collaborator

Study Sites (3)

Los Angeles County-University of Southern California Medical Center

Los Angeles, California, 90033, United States

Location

Olive View Medical Center

Sylmar, California, 91342, United States

Location

Harbor UCLA Medical Center

Torrance, California, 90509, United States

Location

Related Publications (1)

• 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.

  PMID: 33843946 DERIVED

MeSH Terms

Conditions

Critical Illness; Communication

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre- and post study design

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 29, 2019
• Study Start: August 1, 2017
• Primary Completion: December 23, 2019
• Study Completion: December 31, 2019
• Last Updated: November 21, 2025

Record last verified: 2019-10

Locations

US (3)