Virtual Nurse and Social Worker Palliative Care Team to Improve Quality of Life in Veterans With Heart Failure or COPD (VITALVET:ADAPT)
Addressing Symptoms With Person-Centered Treatment (ADAPT) (QUE 25-018)
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85012
- Phoenix VA Health Care System, Phoenix, AZ
-
-
California
-
Long Beach, California, Forente stater, 90822
- VA Long Beach Healthcare System, Long Beach, CA
-
-
Colorado
-
Aurora, Colorado, Forente stater, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
-
Louisiana
-
Shreveport, Louisiana, Forente stater, 71101-4243
- Overton Brooks VA Medical Center, Shreveport, LA
-
-
Pennsylvania
-
Lebanon, Pennsylvania, Forente stater, 17042-7529
- Lebanon VA Medical Center, Lebanon, PA
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02908-4734
- Providence VA Medical Center, Providence, RI
-
-
Wyoming
-
Cheyenne, Wyoming, Forente stater, 82001
- Cheyenne VA Medical, Cheyenne, WY
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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, chronic obstructive pulmonary disease (COPD), or interstitial lung disease, defined as 2 or more outpatient or community care provider visit encounters with a qualifying International Classification of Diseases (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 Functional Assessment of Chronic Illness Therapy-General (FACT-G) score ≤ 70 at screening
- Consistent access to a telephone
Exclusion Criteria:
- Dementia diagnosis (any inpatient, outpatient, or community care encounter with qualifying International Classification of Diseases (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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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).
Andre navn:
A virtual nurse and social worker team provides direct care to eligible Veterans with heart failure or chronic obstructive pulmonary disease (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.
Andre navn:
|
|
Eksperimentell: 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.
|
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).
Andre navn:
A virtual nurse and social worker team provides direct care to eligible Veterans with heart failure or chronic obstructive pulmonary disease (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.
Andre navn:
|
|
Ingen inngripen: Usual Care (Pre-Implementation Control Period)
Practice groups during their pre-implementation period provide usual care for eligible Veterans with heart failure or chronic obstructive pulmonary disease (COPD) without the virtual nurse and social worker team.
In the stepped-wedge design, all practice groups eventually transition to their assigned intervention arm.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Health-Related Quality of Life - Functional Assessment of Chronic Illness Therapy-General (FACT-G) Total Score
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Depression - Patient Health Questionnaire-8 (PHQ-8)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year after Veteran enrollment
|
Death from any cause, ascertained from the VA Death Ascertainment File.
|
1 year after Veteran enrollment
|
|
All-Cause Hospitalization
Tidsramme: 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
Tidsramme: 1 year after Veteran enrollment
|
Time to first hospice enrollment, ascertained from VA inpatient records.
|
1 year after Veteran enrollment
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Reach - Proportion of Eligible Veterans Enrolled
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
|
Cost of implementation
Tidsramme: 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
|
|
Effectiveness - Costs of Care
Tidsramme: Start through end of implementation phase, an average of 1.5 years
|
In-patient hospitalizations, outpatient care Emergency Department (ED), hospice utilization and costs (VA-delivered and VA-purchased)
|
Start through end of implementation phase, an average of 1.5 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: David Bekelman, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- QUX 26-007
- QUE 25-018 (Annet stipend/finansieringsnummer: VA Quality Enhancement Research Initiative (QUERI))
- QUX 26-006 (VA Quality Enhancement Research Initiative (QUERI))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .