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Goals of Care Conversations Training for Seriously Ill Patients (LSTDI Trial)

N/A

Waitlist Available

Led By David Bekelman, MD MPH

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of cancer, heart failure, interstitial lung disease, chronic obstructive pulmonary disease, end-stage renal disease, end-stage liver disease, and dementia

Be older than 18 years old

Must not have

Under 18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of stage 1 to 9 months after the start of stage 2

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ways to help Veterans express their preferences for life-sustaining treatments, so that their wishes can be honored.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on communication strategies rather than medical treatments, there are no direct physical side effects. However, discussions about end-of-life care can be emotionally impactful for both patients and caregivers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of stage 1 to 9 months after the start of stage 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of stage 1 to 9 months after the start of stage 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of stage 1 to 9 months after the start of stage 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of patients with a goals of care conversation note documented in Stage 2

Secondary study objectives

Percent of patients with a goals of care conversation note documented in Stage 1

Percent of patients with a goals of care conversation note documented in Stage 1 or 2

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Low then high patient engagementActive Control4 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 engagementActive Control3 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 engagementActive Control3 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 engagementActive Control3 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.

0 / 2Eligibility criteria met