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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. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

420

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Andere Namen:
  • ADAPT intervention; palliative telecare team; nurse-social worker virtual team
Verhalten: 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).
Andere Namen:
  • Educational Outreach and Implementation Facilitation (enhanced)
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.
Verhalten: 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.
Andere Namen:
  • ADAPT intervention; palliative telecare team; nurse-social worker virtual team
Verhalten: 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).
Andere Namen:
  • Educational Outreach and Implementation Facilitation (standard)
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Health-Related Quality of Life - Functional Assessment of Chronic Illness Therapy-General (FACT-G) Total Score
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Depression - Patient Health Questionnaire-8 (PHQ-8)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 year after Veteran enrollment
Death from any cause, ascertained from the VA Death Ascertainment File.
1 year after Veteran enrollment
All-Cause Hospitalization
Zeitfenster: 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
Zeitfenster: 1 year after Veteran enrollment
Time to first hospice enrollment, ascertained from VA inpatient records.
1 year after Veteran enrollment

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Reach - Proportion of Eligible Veterans Enrolled
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

VA Office of Research and Development

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2029

Studienabschluss (Geschätzt)

30. September 2030

Studienanmeldedaten

Zuerst eingereicht

15. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juli 2026

Zuerst gepostet (Tatsächlich)

20. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • QUX 26-007
  • QUE 25-018 (Andere Zuschuss-/Finanzierungsnummer: VA Quality Enhancement Research Initiative (QUERI))
  • QUX 26-006 (VA Quality Enhancement Research Initiative (QUERI))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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