TLT Training for Emergency Care Decisions

Overseen By Kei Ouchi, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Non-English speaking, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve decision-making for seriously ill older adults in the emergency room. It tests a structured conversation method, called TLT training, which helps doctors and patients or their loved ones make choices about intensive care. The trial includes two groups: one where doctors use this new conversation method and another where they don't. Eligible participants are those over 50 with serious health issues, such as advanced cancer or severe lung disease, who are being considered for intensive care. Participants must speak English and be able to consent or have a surrogate to assist in decision-making. As an unphased trial, this study offers a unique opportunity to enhance communication and decision-making in critical care settings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this TLT training is safe for emergency care decisions?

Research shows that Time-Limited Trials (TLT) training is a method used in emergency rooms for structured conversations. Studies have found that it helps discuss what is important to seriously ill patients or their family members. Experts in emergency medicine recommend this approach to aid decision-making about intensive care.

Regarding safety, no direct evidence indicates physical harm, as TLT training involves talking, not medical procedures or drugs. The goal is to improve communication between doctors and patients, which is generally considered safe and well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TLT training for emergency care decisions because it offers a fresh approach to improving decision-making among healthcare professionals in emergency departments. Unlike traditional training methods that may focus heavily on textbook knowledge and standard procedures, TLT training emphasizes real-time, hands-on learning and adaptability. This method could lead to quicker, more accurate decisions in high-pressure situations, potentially improving patient outcomes. By enhancing the skills of attending physicians, residents, and mid-level providers, TLT training aims to elevate the overall quality of care in emergency settings.

What evidence suggests that TLT training is effective for shared decision-making in intensive care use?

Research has shown that Time-Limited Trials (TLT) can enhance decision-making for intensive care in seriously ill patients. In this trial, some participants will receive TLT training, which offers a structured approach for doctors and patients to discuss care options based on the patient's values. This method ensures that the care provided aligns with the patient's preferences. Early findings suggest that TLT leads to more patient-focused decisions, meaning the care aligns more closely with the patient's wishes and needs. Although more research is needed, early results are promising for making intensive care decisions clearer and more patient-centered. ^{1 2 6 7 8}

Who Is on the Research Team?

Kei Ouchi, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for emergency department clinicians and seriously ill older adults entering ICU from the ED. Adults must be over 50 with a life-limiting illness or over 75, expected to possibly pass away during hospital stay, and speak English. Clinicians must consent to training.

Inclusion Criteria

Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists

Exclusion Criteria

Unable or unwilling to provide informed consent; or Non-English speaking; or Clinically inappropriate, determined by emergency clinicians, and no surrogate is available

I am not willing to participate in or be assigned to emergency training.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for outcomes such as patient-centered decision-making and alignment with end-of-life care preferences

1 week

What Are the Treatments Tested in This Trial?

Interventions

• TLT training

Trial Overview The study tests 'Time-limited Trials' (TLT) training for clinicians. It's about having structured conversations for decision-making on intensive care use among seriously ill older patients admitted from the ED.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists.

Group II: Control group Active Control 1 Intervention

Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

The manuscript outlines essential training concepts for managing in-hospital emergencies, highlighting international courses like the Basic Life Support and Advanced Life Support courses by the European Resuscitation Council (ERC).

The introduction of the European Trauma Course focuses on both technical and non-technical skills for treating trauma patients, emphasizing the need for monitoring the quality of medical emergency teams to identify areas for improvement in training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Training concepts for in-hospital emergencies]. Fritzsche, K., Jantzen, T., Rüsseler, M., et al.[2013]

In a study of 193 pediatric patients with severe traumatic brain injury (sTBI), 53% experienced at least one adverse event (AE), highlighting the high risk of complications in this vulnerable population.

The most common AE was decubitus ulcers, and patients with AEs had longer hospital stays and higher costs, indicating that identifying and preventing AEs can improve patient safety and reduce healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. Charyk Stewart, T., Luong, K., Alharfi, I., et al.[2021]

A study involving 74 doctors over 2 years showed that formal training in trauma management, particularly through Advanced Trauma Life Support (ATLS) courses, significantly improved knowledge and skills compared to a control group.

The results suggest that both ATLS and induction courses for junior doctors in Accident and Emergency (A&E) are effective, with ATLS participants achieving higher scores, indicating the potential for standardized assessments to evaluate and improve trauma management training.

NCBI (Pubmed)

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A method to measure the value of formal training in trauma management: comparison between ATLS and induction courses. Gautam, V., Heyworth, J.[2019]

A systematic review of 27 articles revealed that there is currently no consistent and effective training program for emergency medical team leaders, highlighting a significant gap in preparing medical professionals for leadership roles in emergencies.

While one study showed success in training paramedics in empowering leadership skills, the overall literature indicates that the lack of effective leadership training can severely impact performance in critical clinical situations.

NCBI (Pubmed)

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A search for training of practising leadership in emergency medicine: A systematic review. Larsen, T., Beier-Holgersen, R., Meelby, J., et al.[2022]

Emergency team training significantly improved treatment capacity in simulated trauma emergencies, with participants scoring an average of 59.6 points one year after training compared to 28.8 points before training.

The most notable improvements were in primary assessment skills, procedures, and nontechnical skills, indicating that intensive scenario training effectively enhances both technical and communication abilities in emergency medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Effectiveness and Impact on Safety, Treatment Quality, and Communication in Prehospital Emergency Care: The Prospective Longitudinal Mixed-Methods EPPTC Trial. Häske, D., Beckers, SK., Dieroff, M., et al.[2023]

A systematic review of 130 studies on muscle strengthening training (MST) in youth revealed that only 33.8% reported on adverse events (AEs), highlighting a significant gap in safety monitoring during these interventions.

Among the studies that did report AEs, 40.1% documented at least one adverse event, with over half of the reported events (59.1%) linked directly to the training or testing, indicating a need for better definitions and reporting practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. Mack, DE., Anzovino, D., Sanderson, M., et al.[2023]

A pilot study involving 18 resident physicians showed that a standardized simulation-based error management training (EMT) curriculum significantly improved participants' confidence and cognitive knowledge in managing iatrogenic procedural complications.

After the training, residents performed critical actions more effectively during simulations, indicating that structured EMT can enhance both knowledge and practical skills in handling medical errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iatrogenic Critical Care Procedure Complication Boot Camp: A Simulation-based Pilot Study. Riefkohl-Ortiz, E., Frey, JA., Yee, J., et al.[2023]

In a study of 1367 children treated in a pediatric emergency department, 2.5% experienced adverse events related to their care, highlighting a significant risk of harm in this setting.

Most of these adverse events (87.9%) were deemed preventable, with management and diagnostic issues being the most common types, indicating areas where patient safety can be improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the paediatric emergency department: a prospective cohort study. Plint, AC., Stang, A., Newton, AS., et al.[2021]

A systematic review of 9 studies found that Trauma Team Training (TTT) did not significantly reduce mortality rates in severely injured patients, with a pooled odds ratio of 0.83, indicating no clear benefit in survival outcomes.

However, TTT was associated with faster times to critical interventions, such as getting patients to the operating theatre and receiving CT scans, suggesting it may improve the efficiency of trauma care despite unclear effects on overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is the Clinical Evidence Supporting Trauma Team Training (TTT): A Systematic Review and Meta-Analysis. Noonan, M., Olaussen, A., Mathew, J., et al.[2020]

A survey of 1,332 senior pediatric emergency clinicians revealed that at least 80% recommend practicing critical procedures like CPR and intubation annually to maintain skills, highlighting the importance of regular training in pediatric emergency care.

Simulation training was preferred for most procedures, while alternative clinical settings were favored for airway management techniques, indicating a tailored approach to learning based on the specific procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferred learning modalities and practice for critical skills: a global survey of paediatric emergency medicine clinicians. Craig, SS., Auerbach, M., Cheek, JA., et al.[2019]

Trauma teams lacking structured training experience poor team dynamics, which can delay patient care and negatively impact outcomes.

Implementing evidence-based trauma team training in resource-restricted emergency departments can improve communication and reduce errors, ultimately enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and implementation of a trauma team education program in Georgetown, Guyana. Ramirez, R., Cook, C., Van Meter, J.[2023]

Decision aids are effective tools that enhance patient understanding of medical options and improve communication between patients and clinicians, particularly in emergency department settings where their use is still being explored.

A consensus conference identified six key research domains to prioritize the development of shared decision-making interventions in emergency care, focusing on content, evidence levels, tool design, risk communication, stakeholder involvement, and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Testing of Shared Decision Making Interventions for Use in Emergency Care: A Research Agenda. Melnick, ER., Probst, MA., Schoenfeld, E., et al.[2018]

Emergency nurses can improve their triage decision-making skills through simulations and reflective practices, which help them understand the clinical information and decision-making processes involved in patient triage.

Using real triage cases in simulations, along with verbal protocols for reflection, allows novice nurses to learn from experienced mentors and enhances their ability to make rapid and effective triage decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triage decision making: educational strategies. Cioffi, J.[2019]

A survey of 321 medical trainees revealed that 61% believe adverse patient events are preventable, highlighting a strong belief in the potential for error reduction strategies.

Most trainees (88%) emphasized the importance of improved teamwork and procedural training in reducing medical mishaps, indicating a readiness to engage with patient safety initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes about patient safety: a survey of physicians-in-training. Sorokin, R., Riggio, JM., Hwang, C.[2015]

The workshop introduced the term 'evidence-based clinical algorithms' to better describe the integration of evidence into clinical pathways and guidelines, highlighting the need for improved knowledge translation (KT) in emergency medicine.

Four key research themes were identified to enhance KT: organizational, cognitive, social, and motivational factors, with a consensus that efforts should primarily focus on optimizing organizational factors to improve the use of evidence in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward improved implementation of evidence-based clinical algorithms: clinical practice guidelines, clinical decision rules, and clinical pathways. Gaddis, GM., Greenwald, P., Huckson, S.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11666031/

Study protocol for a randomized controlled trial Time-limited trial (TLT) is a structured approach between clinicians and seriously ill patients or their surrogates to discuss patients' values ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06378151?term=AREA%5BConditionSearch%5D(%22Emergencies%22)&rank=7

Time-limited Trials in the Emergency Department Researchers will compare clinicians using TLT with those providing usual care to see if TLT leads to improved patient-centered decision-making and better ...

3. researchgate.net researchgate.net/publication/387343581_Study_protocol_for_a_randomized_controlled_trial_Integrating_the_'Time-limited_Trial'_in_the_emergency_department

(PDF) Study protocol for a randomized controlled trial Discussion This study protocol will investigate the potential of TLT initiated in the ED to lead to patient-centered intensive care utilization.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S088394412200096X

Time-dependent uncertainty of critical care transitions in ... This study presents a probabilistic method to estimate a suitable duration of a TLT based on temporal profiles of uncertainty about critical care and outcome.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12107277/

Comparing Performance Outcomes of Emergency ... Although EM-trained physicians achieved shorter waiting and ED stay time and lower rate of failing to visit patients within the required time and unscheduled ...

6. escholarship.org escholarship.org/content/qt0f44g9qw/qt0f44g9qw.pdf

Study protocol for a randomized controlled trial TLT has been also published as an expert-recommended approach in Annals of Emergency Medicine [24]. Decisions to initiate intensive care often.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40452873/

Comparing Performance Outcomes of Emergency ... We compared the two physician groups for quality-of-care outcomes, including waiting time, rate of failing to visit patients within the required ...

8. journal.medtigo.com journal.medtigo.com/systematic-literature-review-the-role-of-artificial-intelligence-in-emergency-department-decision-making/

The Role of AI in Emergency Department Decision Making Explore how AI optimizes ED decision-making, improves diagnostic accuracy, triage, and outcome predictions, with a focus on safety.