Goals of Care Conversations Training for Seriously Ill Patients

(LSTDI Trial)

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

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The long term goal is to improve quality of care in Veterans with serious illnesses by aligning medical care with Veterans' goals and values. The objective of this study is to use a sequentially randomized trial to determine what implementation strategies are effective to increase early, outpatient goals of care conversations. The study will use interviews with and surveys of medical providers, patients, and caregivers, along with medical record data. This work is significant because it tests ways Veterans can express their goals and preferences for life sustaining treatments and have them honored.

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+