Virtual Palliative Care for Heart Failure or COPD

(VITALVET:ADAPT Trial)

Enrolling by invitation at 6 trial locations
CA
DB
Overseen ByDavid Bekelman, MD MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a virtual care team, consisting of a nurse and a social worker, can improve the well-being and quality of life for Veterans with heart failure or COPD. The trial compares two support methods for this care team: Enhanced Implementation Support and Standard Implementation Support. Veterans experiencing significant impacts on daily life due to heart failure or COPD may be well-suited for this study. The goal is to determine if this approach can better manage symptoms like breathlessness and fatigue while also addressing emotional and mental health needs. As an unphased trial, it offers Veterans a unique opportunity to contribute to innovative care solutions that may enhance their daily lives.

What prior data suggests that this virtual palliative care approach is safe for Veterans with heart failure or COPD?

Research has shown that the virtual nurse and social worker palliative care team is safe and well-received by patients with heart failure or COPD. Studies have found that patients receiving this care reported a better quality of life, indicating the treatment's effectiveness and manageability.

These studies reported no major side effects, reassuring for safety. Most patients completed the treatment as planned, with many finishing it after six months. This suggests that most patients could adhere to the treatment without significant issues.

Overall, these findings suggest that the virtual palliative care approach is safe, offering peace of mind for those considering joining the trial.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they aim to revolutionize palliative care for heart failure and COPD patients with a virtual approach. Traditionally, palliative care relies on in-person visits and support, but these new methods use a virtual nurse and social worker team, making it more accessible and potentially more consistent for patients. The "Enhanced Implementation Support" arm of the trial includes innovative strategies like pre-implementation activities and sustainability planning, which could lead to more effective and lasting integration of this virtual care model. By exploring these new methods, researchers hope to improve the quality of care and support for these patients, making it easier for them to manage their conditions and maintain their well-being.

What evidence suggests that this trial's treatments could be effective for heart failure or COPD?

Research has shown that a virtual team consisting of a nurse and a social worker can enhance the quality of life for patients with heart failure or COPD. In this trial, some participants will receive care from this virtual team with Enhanced Implementation Support, while others will receive Standard Implementation Support. Studies have found that patients under the care of this team experience greater well-being compared to those receiving regular care. Specifically, one study revealed that patients experienced less depression and anxiety, common issues in these conditions. Additionally, the care improved patients' perceptions of their heart or lung health. These findings suggest that this approach can significantly benefit individuals managing these chronic conditions.12367

Who Is on the Research Team?

DB

David Bekelman, MD MPH

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

This trial is for Veterans diagnosed with heart failure, COPD, or interstitial lung disease who are at high risk of being hospitalized or dying from their condition. Participants should be experiencing symptoms like breathlessness, fatigue, depression, or anxiety.

Inclusion Criteria

Care Assessment Need (CAN) 3.0 score ≥ 90 at some point in the prior 6 months
At least one primary care encounter in the past year, identified by primary care stop codes (301, 322, 323, 342, 348, 350, 704)
Poor self-reported quality of life, defined as a FACT-G score ≤ 70 at screening
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Exclusion Criteria

I have been diagnosed with cancer in the past year.
Current substance misuse (at least 1 inpatient or outpatient encounter with a qualifying substance/alcohol ICD code or stop code in the prior 6 months)
I have been diagnosed with dementia in the past 3 years.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Implementation

Practice groups provide usual care for eligible Veterans with heart failure or COPD without the virtual nurse and social worker team

3 months

Implementation

Virtual nurse and social worker palliative care intervention is implemented with either standard or enhanced support

18 months
Weekly collaborative case reviews

Follow-up

Participants are monitored for quality of life, depression, anxiety, and other outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Implementation Support
  • Standard Implementation Support
  • Virtual Nurse and Social Worker Palliative Care Team

Trial Overview

The study tests if a virtual care team—consisting of a nurse and social worker—can improve quality of life and emotional well-being in Veterans compared to usual care. It also compares two ways (enhanced vs standard) to help VA sites start this program.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: EBP + Standard Implementation SupportExperimental Treatment2 Interventions
Group II: EBP + Enhanced Implementation SupportExperimental Treatment2 Interventions
Group III: Usual Care (Pre-Implementation Control Period)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38227034/

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