Virtual Nurse and Social Worker Palliative Care Team to Improve Quality of Life in Veterans With Heart Failure or COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Nurse and Social Worker Palliative Care Team, Enhanced Implementation Support, Standard Implementation Support.
- Who it may be relevant to
- Registry conditions: Heart Failure, Pulmonary Disease, Chronic Obstructive, Interstitial Lung Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Addressing Symptoms With Person-Centered Treatment (ADAPT) (QUE 25-018)
Overview
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.
Detailed description
Heart failure (HF) and chronic obstructive pulmonary disease (COPD) together affect nearly 1 in 4 Veterans and are among the leading causes of hospitalization, mortality, and poor quality of life in the Veterans Health Administration (VHA). Veterans with these conditions frequently experience depression (50-60%), anxiety (30-40%), breathlessness (44-85%), and fatigue (66-85%). Despite this burden, palliative symptom management and psychosocial support are not routinely delivered in primary care settings.
This study implements a virtual nurse and social worker palliative care team that provides direct patient care to Veterans with HF or COPD at high risk of hospitalization or death. The intervention was tested in a VHA-funded, patient-level randomized controlled trial across two VHA health systems, demonstrating clinically meaningful improvements in quality of life (primary outcome), depression, anxiety, and disease-specific health status at 4 and 6 months, with sustained quality of life effects at 12 months. Documentation of Veteran values and goals increased from 37% to nearly 80% in the intervention group vs. 42% in control.
The current study implements this evidence-based practice (EBP) in routine VHA care across 8 VA health care systems. A nurse and social worker( provide virtual care by phone or VA Video Connect directly to eligible Veterans, collaborating with each Veteran's primary care provider and palliative care clinician. The nurse conducts structured symptom assessments and uses motivational interviewing to help Veterans achieve activity, symptom reduction, and quality of life goals. The social worker delivers brief structured counseling based on behavioral activation and interpersonal psychotherapy, addressing activity goals, pacing, role change, and relaxation. Collaborative case review occurs weekly with a representative primary care provider and palliative care clinician, with placement of orders for the treating PCP to sign. Up to 30 Veterans per practice group per wave are reviewed for eligibility and up to 10 are expected to enroll per practice group per wave.
Practice groups within each site are randomized to one of six implementation waves in a cluster-randomized stepped-wedge design, with one practice group per site rolling out every 3 months beginning July, 2026, such that all 8 sites progress through the same 6-wave timeline in parallel. Covariate-constrained randomization was used to balance site-level characteristics (rurality and site engagement level) across the two implementation support conditions.
In addition to examining the effectiveness of the clinical intervention, this study compares two levels of implementation support. Four sites receive standard implementation support and four sites receive enhanced implementation support. Standard support includes site identification, clinician engagement, tailored training and implementation plans, fidelity monitoring, clinical office hours, adaptations tracking, sustainability planning, and dissemination of data and best practices. Enhanced support includes all standard components plus baseline process mapping, a brainwriting premortem exercise during pre-implementation, and during implementation: structured audit and feedback, updated process maps, and facilitation check-in meetings. During sustainability, enhanced sites additionally receive check-in meetings and emails. Both clinical effectiveness outcomes (Veteran-reported quality of life and related measures) and implementation outcomes (reach, adoption, fidelity, and sustainment) are examined across the two implementation support conditions.
A difference-in-differences analytic approach, aligned with the Callaway and Sant'Anna framework, is used to estimate causal effects of the intervention. Surveys of Veteran-reported outcomes are administered every 6 months to eligible Veterans at all practice groups throughout pre-implementation, implementation, and sustainment periods.
Interventions
- Behavioral Virtual Nurse and Social Worker Palliative Care Team
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, pac - Behavioral Enhanced Implementation Support
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). - Behavioral Standard Implementation Support
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).
Primary outcome measures
- 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)]
Secondary outcome measures (7)
- Depression - Patient Health Questionnaire-8 (PHQ-8) [Time frame: Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years]
- Anxiety - Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years]
- Suicidality - Columbia Suicide Severity Rating Scale (C-SSRS) [Time frame: Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years]
- Documentation of Goals and Preferences/Life-Sustaining Treatment Note [Time frame: Baseline (any prior documentation) and at 6 and 12 months after Veteran enrollment (any new or updated documentation during follow-up)]
- All-Cause Mortality [Time frame: 1 year after Veteran enrollment]
- All-Cause Hospitalization [Time frame: 1 year after Veteran enrollment]
- Hospice Utilization [Time frame: 1 year after Veteran enrollment]
Eligibility criteria
Inclusion criteria
- At least one primary care encounter in the past year, identified by primary care stop codes (301, 322, 323, 342, 348, 350, 704)
- Diagnosed with heart failure, COPD, or interstitial lung disease, defined as 2 or more outpatient or community care provider visit encounters with a qualifying ICD code at least 30 days apart, or 1 inpatient hospitalization with a qualifying ICD code as the primary discharge diagnosis, within the past year
- Care Assessment Need (CAN) 3.0 score ≥ 90 at some point in the prior 6 months
- Poor self-reported quality of life, defined as a FACT-G score ≤ 70 at screening
- Consistent access to a telephone
Exclusion criteria
- Dementia diagnosis (any inpatient, outpatient, or community care encounter with qualifying ICD code in the prior 3 years)
- Cancer diagnosis (2 or more outpatient or community care provider visit encounters, or 1inpatient primary discharge diagnosis, with a qualifying ICD code in the prior 1 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)
- Currently receiving palliative care (at least 1 inpatient or outpatient encounter with palliative care stop codes 351 or 353 in the prior 1 year)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 7 centers
- Phoenix VA Health Care System, Phoenix, AZ — Phoenix
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
- Overton Brooks VA Medical Center, Shreveport, LA — Shreveport
- Lebanon VA Medical Center, Lebanon, PA — Lebanon
- Providence VA Medical Center, Providence, RI — Providence
- Cheyenne VA Medical, Cheyenne, WY — Cheyenne
Identifiers
NCT: NCT07714252 · QUX 26-007 · QUE 25-018 · QUX 26-006