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

Primary Purpose

Critical Illness, Communication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family meetings using time limited trials as default ICU communication and care planning approach
Usual practice
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Critical Illness focused on measuring Palliative Care, Medical Futility, Intensive Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Los Angeles County-University of Southern California Medical Center
  • Olive View Medical Center
  • Harbor UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pre-intervention

Post-intervention

Arm Description

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

Outcomes

Primary Outcome Measures

ICU Length of Stay
ICU LOS will be collected using the electronic medical record

Secondary Outcome Measures

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

Full Information

First Posted
October 31, 2019
Last Updated
February 18, 2020
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
Los Angeles Department of Health Services, University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04181294
Brief Title
Time Limited Trials to Reduce Non-Beneficial Intensive Care Unit Treatments
Official Title
Time Limited Trials to Reduce Non-Beneficial Intensive Care Unit Treatments Among Critically-ill Patients With Advanced Medical Illnesses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
Los Angeles Department of Health Services, University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Communication
Keywords
Palliative Care, Medical Futility, Intensive Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Pre- and post study design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention
Arm Type
Experimental
Arm Description
Baseline data on patient characteristics and outcomes will be collected for 4 months prior to intervention.
Arm Title
Post-intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Family meetings using time limited trials as default ICU communication and care planning approach
Intervention Description
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
Intervention Name(s)
Usual practice
Intervention Description
Baseline practice of ICU communication and care planning
Primary Outcome Measure Information:
Title
ICU Length of Stay
Description
ICU LOS will be collected using the electronic medical record
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Hospital LOS will be collected using the electronic medical record
Time Frame
4 months
Title
Days receiving life-sustaining ICU treatments
Description
Total number of days receiving mechanical ventilation, vasopressor medications, and renal replacement therapy will be collected from the electronic health record
Time Frame
4 months
Title
Use of invasive ICU procedures
Description
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
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Key process measure: Family meetings
Description
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
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Los Angeles County-University of Southern California Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Olive View Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33843946
Citation
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.
Results Reference
derived

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

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