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
- Heart Failure
- Interstitial Lung Disease
- Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Virtual Nurse and Social Worker Palliative Care Team — BEHAVIORALA 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 — BEHAVIORALEnhanced 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 — BEHAVIORALStandard 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 SupportFour 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 SupportFour 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
- David Bekelman, MD MPH(720) 857-2809
- Chelsea A Leonard, PhD
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Phoenix VA Health Care System, Phoenix, AZ | Phoenix | Arizona | 85012 | Krystle Johnson-Reed, RN Donna Seton, PA-C |
| VA Long Beach Healthcare System, Long Beach, CA | Long Beach | California | 90822 | Donna Sheehan, RN Rebecca Yamarik, MD |
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045-7211 | David Bekelman, MD MPH (PRINCIPAL_INVESTIGATOR) |
| Overton Brooks VA Medical Center, Shreveport, LA | Shreveport | Louisiana | 71101-4243 | Stephanie Branch, RN Marilyn Latin, MD |
| Lebanon VA Medical Center, Lebanon, PA | Lebanon | Pennsylvania | 17042-7529 | Melissa Buchinski, RN Rachel Causak, MD |
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908-4734 | Patrician Lamarre, RN Mitchell Wice, MD |
| Cheyenne VA Medical, Cheyenne, WY | Cheyenne | Wyoming | 82001 | Erin Kramer, RN Jannene Sebesta, MD |
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