Goals of Care Conversations Training for Seriously Ill Patients

(LSTDI Trial)

Not currently recruiting at 2 trial locations

Overseen By David Bekelman, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Prisoner, Pregnant, Under 18, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve the care of Veterans with serious illnesses by aligning medical treatment with their personal goals and values. Researchers test various strategies, such as the Clinician Implementation Strategy (Stage 1 and Stage 2), to facilitate meaningful conversations between doctors and patients about care preferences. The goal is to identify the best methods to ensure these important discussions occur early and effectively. Veterans with conditions like cancer, heart failure, or dementia who receive care within the VA system may qualify to participate. As an unphased trial, this study allows Veterans to contribute to research that could enhance care practices and improve patient-doctor communication.

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 these implementation strategies are safe for improving care in seriously ill patients?

Research shows that good communication is crucial when discussing serious illnesses. Studies have examined how doctors and patients talk about treatment goals, which is important to ensure the treatment aligns with the patient's desires and values.

In this trial, the treatment involves training doctors and encouraging patients to take a more active role in their care. Previous research on these methods shows they can improve health care. For instance, when patients are more involved, they often experience better health outcomes. Additionally, well-trained doctors can have more effective conversations about treatment goals.

Importantly, this trial does not involve any drugs or new medical procedures. The focus is on enhancing communication and patient involvement, meaning there are no known risks or side effects, making it a low-risk trial for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance communication between clinicians and seriously ill patients through structured training and engagement strategies. Unlike traditional care, which may not emphasize the dynamics of patient engagement and clinician training intensity, this trial investigates how varying levels of patient involvement and clinician preparation can impact the effectiveness of care conversations. By examining different combinations of engagement and training intensity, the trial aims to identify the most effective strategies for improving these crucial discussions, potentially leading to more personalized and impactful patient care.

What evidence suggests that this trial's treatments could be effective for improving care in seriously ill Veterans?

Research has shown that discussing care goals in serious illness can lead to better patient outcomes and less intensive end-of-life care. This trial will explore different strategies for engaging patients and training clinicians. Studies have found that when patients are ready to discuss their care goals, both patients and doctors engage in more meaningful conversations. This alignment ensures that the care patients receive matches their wishes. Training programs for healthcare providers, included in this trial, enhance the quality of these conversations, reducing anxiety and depression in patients. These programs also boost the confidence and satisfaction of healthcare providers. Overall, these strategies aim to ensure that medical care respects the values and preferences of seriously ill patients. ^{1 6 7 8 9}

Who Is on the Research Team?

David Bekelman, MD MPH

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Anne M Walling, MD PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with serious illnesses like cancer, heart failure, lung diseases, kidney or liver failure, and dementia. They must be enrolled in VHA healthcare at one of the study sites and have a high risk of hospitalization or death within a year. Clinicians eligible are those who need to improve their skills in discussing care goals with patients.

Inclusion Criteria

CLINICIANS VA primary care advance practice clinicians (MDs, APRNs, PAs) at one of the three study sites able to complete goals of care conversation notes and orders. Advance practice clinicians will be eligible for randomization if they have at least 15 eligible patients without goals of care conversation notes at the start of stage 1 (to allow participating clinicians ample opportunities to write notes) and have written fewer than 4 goals of care conversation notes in the previous 6 months (to select clinicians who need improvement), and can potentially receive the planned implementation strategies, i.e., clinicians who regularly attend the Patient Aligned Care Team (PACT) team meetings.

I have been diagnosed with a serious condition like cancer, heart failure, or dementia.

It seems like the criterion you provided is incomplete. Can you please provide more details or context for me to help you better?

Exclusion Criteria

Prisoner

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1

Implementation of low intensity clinician and patient strategies to improve documentation of goals of care conversations

8 months

Stage 2

Implementation of high intensity clinician and patient strategies for non-responders to further improve documentation of goals of care conversations

9 months

Follow-up

Participants are monitored for the effectiveness of the implementation strategies on goals of care conversations

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinician Implementation Strategy Stage 1
• Clinician Implementation Strategy Stage 2
• High patient engagement
• Low patient engagement

Trial Overview The study tests different strategies to help clinicians engage in early conversations about care goals with seriously ill patients. It involves two stages: low intensity training followed by high intensity training for clinicians, paired with varying levels of patient engagement.

How Is the Trial Designed?

Group I: Low then high patient engagement Active Control 4 Interventions

First stage: Low intensity patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): High patient engagement and high intensity clinician training.

Group II: No then low patient engagement Active Control 3 Interventions

First stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training.

Group III: Low then low patient engagement Active Control 3 Interventions

First stage: Low patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training.

Group IV: No then high patient engagement Active Control 3 Interventions

First stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): High patient engagement and high intensity clinician training.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10362669/

Improving serious illness communication: a qualitative ... Research on SICP demonstrates improvements in serious illness conversations, lower rates of anxiety and depression for patients, and positive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10865772/

Education modalities for serious illness communication ... Data has shown that serious illness communication training has a positive impact on provider satisfaction and confidence, but less is known about the impact on ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0885392420306527

Implementing Goals-of-Care Conversations: Lessons From ... ACP is essential to high-quality care for seriously ill patients and includes processes to foster communication regarding patients' values, goals, and ...

4. ariadnelabs.org ariadnelabs.org/serious-illness-care/serious-illness-care-program/

SERIOUS ILLNESS CARE PROGRAM Evidence demonstrates that the program improves conversations and outcomes, such as lower anxiety and depression at end of life, for patients; results in a more ...

5. liebertpub.com liebertpub.com/doi/10.1089/jpm.2019.0334

Evaluation of a Training Program in Three Health Systems The clinician training, tested in two research trials, teaches clinicians to have conversations about patients' values, goals, and prognosis using a scalable ...

6. acpdecisions.org acpdecisions.org/goals-of-care-conversations-a-best-practice-step-by-step-approach/

The Goals-of-Care Conversation: A Best-Practice, Step-By ... Clinicians working with seriously ill patients need to effectively initiate and guide goals-of-care conversations and be able to transition ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0885392424007875

Implementing the Serious Illness Care Program in Safety ... The study aimed to understand factors influencing implementation of a serious illness communication-focused intervention – the Serious Illness Care Program.

8. jpsmjournal.com jpsmjournal.com/article/S0885-3924(23)00056-8/fulltext

The Team-Based Serious Illness Care Program, A ... Team-based SICP consists of three components: 1) Serious Illness Conversation Guide, 2) team member training, and 3) system change (see Fig. 1).

9. researchgate.net researchgate.net/publication/339663273_Goals_of_Care_Conversations_in_Serious_Illness_A_Practical_Guide

Goals of Care Conversations in Serious Illness A Practical ... Excellent communication is required to ensure that the care provided is patient centered and aligns with the patient's values and preferences.