Virtual Nurse and Social Worker Palliative Care Team to Improve Quality of Life in Veterans With Heart Failure or COPD

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
VA Office of Research and Development
Study ID
NCT07714252
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Virtual Nurse and Social Worker Palliative Care Team — BEHAVIORAL
    A virtual nurse and social worker team provides direct care to eligible Veterans with heart failure or COPD by phone or VA Video Connect. The nurse conducts structured symptom assessments and uses motivational interviewing to address the Veteran's most bothersome symptom (breathlessness, fatigue, depression, anxiety, or sleep disturbance).The social worker delivers brief structured counseling based on behavioral activation and interpersonal psychotherapy, including modules on activity goals, pacing, role change, and relaxation. The team engages in weekly collaborative case review with a representative primary care provider and palliative care physician and places orders for the treating PCP to consider. Nurses and social workers receive 8 hours of training in primary palliative care competencies.
  • Enhanced Implementation Support — BEHAVIORAL
    Enhanced implementation support includes all standard support components plus: during pre-implementation, creation of baseline process maps and a structured brainwriting premortem exercise to identify implementation barriers; during implementation, structured audit and feedback, iteratively updated process maps, and facilitation check-in meetings; during sustainability, ongoing check-in meetings and emails. Delivered to across all phases (pre-implementation, implementation, and sustainability).
  • Standard Implementation Support — BEHAVIORAL
    Standard implementation support includes clinician engagement, clinician education and suggested implementation plans, fidelity monitoring, clinical office hours, adaptations tracking, sustainability planning, and dissemination of data and best practices. Delivered to across all phases (pre-implementation, implementation, and sustainability).

Study Details

Many Veterans living with heart failure or chronic obstructive pulmonary disease (COPD) experience significant symptoms - such as breathlessness, fatigue, depression, and anxiety -that reduce their quality of life. Despite how common these symptoms are, they are often not adequately addressed in routine care. This study tests whether a virtual team of a nurse and social worker can improve quality of life, depression, anxiety, and other patient-reported outcomes for Veterans with heart failure or COPD who are at high risk of hospitalization or death. The nurse helps Veterans manage their most bothersome symptoms using a structured approach, and the social worker provides brief counseling to address emotional and psychological concerns. Both work closely with the Veteran's primary care provider and palliative care clinician to coordinate additional care as needed. The study also examines whether enhanced implementation support helps VA sites adopt the program more successfully compared to standard implementation support.

Key Dates

First listed
Jul 20, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: EBP + Enhanced Implementation Support
    Four VA sites (and their associated practice groups) receive the virtual nurse and social worker palliative care intervention supported by enhanced implementation support. Enhanced support includes all standard components plus additional pre-implementation activities (baseline process mapping and a structured brainwriting premortem exercise), additional implementation activities (structured audit and feedback, iteratively updated process maps, and facilitation check-in meetings), and additional sustainability activities (check-in meetings and emails). Practice groups within these sites roll out in a stepped-wedge design with one practice group per wave across 6 waves.
  • Experimental: EBP + Standard Implementation Support
    Four VA sites (and their associated practice groups) receive the virtual nurse and social worker palliative care intervention supported by standard implementation support. Standard support includes clinician engagement, clinician education and suggested implementation plans, fidelity monitoring, clinical office hours, adaptations tracking, sustainability planning, and dissemination of data and best practices. Practice groups within these sites roll out in a stepped-wedge design with one practice group per wave across 6 waves.
  • No Intervention: Usual Care (Pre-Implementation Control Period)
    Practice groups during their pre-implementation period provide usual care for eligible Veterans with heart failure or COPD without the virtual nurse and social worker team. In the stepped-wedge design, all practice groups eventually transition to their assigned intervention arm.

Primary Outcome Measure

Health-Related Quality of Life - Functional Assessment of Chronic Illness Therapy-General (FACT-G) Total Score [ Time Frame: Assessed every 6 months from pre-implementation through sustainment (up to approximately 30 months); primary effectiveness comparison at the end of each Veteran's intervention period (approximately 4-6 months after enrollment) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Phoenix VA Health Care System, Phoenix, AZPhoenixArizona85012
Krystle Johnson-Reed, RN
Donna Seton, PA-C
VA Long Beach Healthcare System, Long Beach, CALong BeachCalifornia90822
Donna Sheehan, RN
Rebecca Yamarik, MD
Rocky Mountain Regional VA Medical Center, Aurora, COAuroraColorado80045-7211
Pamela Rice, PhD
720-218-4015
James P Hill
(720) 830-7685
David Bekelman, MD MPH (PRINCIPAL_INVESTIGATOR)
Overton Brooks VA Medical Center, Shreveport, LAShreveportLouisiana71101-4243
Stephanie Branch, RN
Marilyn Latin, MD
Lebanon VA Medical Center, Lebanon, PALebanonPennsylvania17042-7529
Melissa Buchinski, RN
Rachel Causak, MD
Providence VA Medical Center, Providence, RIProvidenceRhode Island02908-4734
Patrician Lamarre, RN
Mitchell Wice, MD
Cheyenne VA Medical, Cheyenne, WYCheyenneWyoming82001
Erin Kramer, RN
Jannene Sebesta, MD

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