Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

15 lipca 2026 zaktualizowane przez: VA Office of Research and Development

Addressing Symptoms With Person-Centered Treatment (ADAPT) (QUE 25-018)

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

420

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Arizona
    • California
      • Long Beach, California, Stany Zjednoczone, 90822
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045-7211
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • David Bekelman, MD MPH
    • Louisiana
      • Shreveport, Louisiana, Stany Zjednoczone, 71101-4243
    • Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Stany Zjednoczone, 02908-4734
    • Wyoming

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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, 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.
Inne nazwy:
  • ADAPT intervention; palliative telecare team; nurse-social worker virtual team
Behawioralne: 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).
Inne nazwy:
  • Educational Outreach and Implementation Facilitation (enhanced)
Eksperymentalny: 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.
Behawioralne: 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, 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.
Inne nazwy:
  • ADAPT intervention; palliative telecare team; nurse-social worker virtual team
Behawioralne: 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).
Inne nazwy:
  • Educational Outreach and Implementation Facilitation (standard)
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Health-Related Quality of Life - Functional Assessment of Chronic Illness Therapy-General (FACT-G) Total Score
Ramy czasowe: 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)
The FACT-G is a 27-item Veteran-reported measure of health-related quality of life across four domains: physical, social/family, emotional, and functional well-being. Total scores range from 0 to 108, with higher scores indicating better quality of life. A 4-point difference represents the minimal clinically important difference in this population.
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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Depression - Patient Health Questionnaire-8 (PHQ-8)
Ramy czasowe: Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years
Veteran-reported 8-item depression symptom scale. Scores range from 0 to 24; higher scores indicate greater depression severity. Clinically meaningful thresholds occur at increments of 4 points.
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)
Ramy czasowe: Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years
Veteran-reported 7-item anxiety symptom scale. Scores range from 0 to 21; higher scores indicate greater anxiety severity.
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)
Ramy czasowe: Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years
Veteran-reported assessment of suicidal ideation and behavior severity.
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
Ramy czasowe: Baseline (any prior documentation) and at 6 and 12 months after Veteran enrollment (any new or updated documentation during follow-up)
Binary indicator of goals and preferences/life-sustaining treatment note (not titles serve the same purpose but can have either name) is present in the VA electronic health record at baseline, and whether any new or updated documentation occurs during the follow-up period. Ascertained from VA Corporate Data Warehouse Health Factors and TIU notes.
Baseline (any prior documentation) and at 6 and 12 months after Veteran enrollment (any new or updated documentation during follow-up)
All-Cause Mortality
Ramy czasowe: 1 year after Veteran enrollment
Death from any cause, ascertained from the VA Death Ascertainment File.
1 year after Veteran enrollment
All-Cause Hospitalization
Ramy czasowe: 1 year after Veteran enrollment
Any unplanned VA or VA-paid community hospitalization, ascertained from the VA Corporate Data Warehouse (inpatient) and Consolidated Data Set (community care).
1 year after Veteran enrollment
Hospice Utilization
Ramy czasowe: 1 year after Veteran enrollment
Time to first hospice enrollment, ascertained from VA inpatient records.
1 year after Veteran enrollment

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Reach - Proportion of Eligible Veterans Enrolled
Ramy czasowe: Assessed per implementation wave through end of implementation phase(approximately 18 months from Wave 1 start)
Number and proportion of eligible Veterans at each practice group who enroll in the intervention, compared across standard and enhanced implementation support sites. Representativeness by sex, race, ethnicity, and rurality also examined.
Assessed per implementation wave through end of implementation phase(approximately 18 months from Wave 1 start)
Fidelity - Proportion of Intervention Modules Completed
Ramy czasowe: Start through end of implementation phase, an average of 1.5 years
Proportion of enrolled Veterans for whom the nurse and social worker complete all required intervention modules, as documented in the VA electronic health record. Compared across standard and enhanced implementation support sites.
Start through end of implementation phase, an average of 1.5 years
Adoption - Proportion of Practice Groups Implementing the Intervention as Planned
Ramy czasowe: Start through end of implementation phase, an average of 1.5 years
Number and proportion of practice groups that adopt and deliver the intervention, compared across standard and enhanced implementation support sites.
Start through end of implementation phase, an average of 1.5 years
Sustainment - Intent to Maintain Program at End of Implementation Phase
Ramy czasowe: End of implementation phase (approximately 18 months after Wave 1 start)
Proportion of practice groups and sites reporting intent to sustain the intervention beyond the study period, compared across standard and enhanced implementation support conditions. Barriers and facilitators to sustainment also assessed qualitatively.
End of implementation phase (approximately 18 months after Wave 1 start)
Effectiveness - Costs of Care
Ramy czasowe: Start through end of implementation phase, an average of 1.5 years
In-patient hospitalizations, outpatient care ED, hospice utilization and costs (VA-delivered and VA-purchased)
Start through end of implementation phase, an average of 1.5 years
Cost of implementation
Ramy czasowe: Start through end of implementation phase, an average of 1.5 years
costs of replication for new settings, delivery of implementation strategies, delivery of intervention
Start through end of implementation phase, an average of 1.5 years

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

VA Office of Research and Development

Śledczy

  • Główny śledczy: David Bekelman, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2029

Ukończenie studiów (Szacowany)

30 września 2030

Daty rejestracji na studia

Pierwszy przesłany

15 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 lipca 2026

Pierwszy wysłany (Rzeczywisty)

20 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • QUX 26-007
  • QUE 25-018 (Inny numer grantu/finansowania: VA Quality Enhancement Research Initiative (QUERI))
  • QUX 26-006 (VA Quality Enhancement Research Initiative (QUERI))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be shared publicly due to VA data governance and privacy requirements governing data within the VA Corporate Data Warehouse and Qualtrics survey infrastructure. Aggregate study results will be disseminated through peer-reviewed publications and VHA partner reports.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Niewydolność serca

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Egypt

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
Subskrybuj