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

15 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

420

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Arizona
    • California
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045-7211
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • David Bekelman, MD MPH
    • Louisiana
      • Shreveport, Louisiana, Stati Uniti, 71101-4243
    • Pennsylvania
    • Rhode Island
    • Wyoming

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Altri nomi:
  • ADAPT intervention; palliative telecare team; nurse-social worker virtual team
Comportamentale: 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).
Altri nomi:
  • Educational Outreach and Implementation Facilitation (enhanced)
Sperimentale: 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.
Comportamentale: 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.
Altri nomi:
  • ADAPT intervention; palliative telecare team; nurse-social worker virtual team
Comportamentale: 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).
Altri nomi:
  • Educational Outreach and Implementation Facilitation (standard)
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Health-Related Quality of Life - Functional Assessment of Chronic Illness Therapy-General (FACT-G) Total Score
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depression - Patient Health Questionnaire-8 (PHQ-8)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 year after Veteran enrollment
Death from any cause, ascertained from the VA Death Ascertainment File.
1 year after Veteran enrollment
All-Cause Hospitalization
Lasso di tempo: 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
Lasso di tempo: 1 year after Veteran enrollment
Time to first hospice enrollment, ascertained from VA inpatient records.
1 year after Veteran enrollment

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Reach - Proportion of Eligible Veterans Enrolled
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

VA Office of Research and Development

Investigatori

  • Investigatore principale: David Bekelman, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 dicembre 2029

Completamento dello studio (Stimato)

30 settembre 2030

Date di iscrizione allo studio

Primo inviato

15 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 luglio 2026

Primo Inserito (Effettivo)

20 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • QUX 26-007
  • QUE 25-018 (Altro numero di sovvenzione/finanziamento: VA Quality Enhancement Research Initiative (QUERI))
  • QUX 26-006 (VA Quality Enhancement Research Initiative (QUERI))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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