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

NCT07714252 | Not Yet Recruiting

• 3 other identifiers: QUX 26-007QUE 25-018QUX 26-006
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Interstitial Lung Disease

Keywords

Palliative Care; Quality of Life; Veterans Health; Telemedicine; Social Work; Implementation Science; Symptom Management; Patient-Reported Outcomes; Motivational Interviewing; Nurses

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life - Functional Assessment of Chronic Illness Therapy-General (FACT-G) Total Score

  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)

Secondary Outcomes (7)

• Depression - Patient Health Questionnaire-8 (PHQ-8)

  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)

  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)

  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

  Baseline (any prior documentation) and at 6 and 12 months after Veteran enrollment (any new or updated documentation during follow-up)

• All-Cause Mortality

  1 year after Veteran enrollment

Other Outcomes (6)

• Reach - Proportion of Eligible Veterans Enrolled

  Assessed per implementation wave through end of implementation phase(approximately 18 months from Wave 1 start)

• Fidelity - Proportion of Intervention Modules Completed

  Start through end of implementation phase, an average of 1.5 years

• Adoption - Proportion of Practice Groups Implementing the Intervention as Planned

  Start through end of implementation phase, an average of 1.5 years

Study Arms (3)

EBP + Enhanced Implementation Support

EXPERIMENTAL

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.

Behavioral: Virtual Nurse and Social Worker Palliative Care Team; Behavioral: Enhanced Implementation Support

EBP + Standard Implementation Support

EXPERIMENTAL

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.

Behavioral: Virtual Nurse and Social Worker Palliative Care Team; Behavioral: Standard Implementation Support

Usual Care (Pre-Implementation Control Period)

NO INTERVENTION

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.

Interventions

Virtual Nurse and Social Worker Palliative Care Team BEHAVIORAL

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.

Also known as: ADAPT intervention; palliative telecare team; nurse-social worker virtual team

EBP + Enhanced Implementation Support; EBP + Standard Implementation Support

Enhanced Implementation Support BEHAVIORAL

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).

Also known as: Educational Outreach and Implementation Facilitation (enhanced)

EBP + Enhanced Implementation Support

Standard Implementation Support BEHAVIORAL

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).

Also known as: Educational Outreach and Implementation Facilitation (standard)

EBP + Standard Implementation Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (7)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012, United States

Location

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

Overton Brooks VA Medical Center, Shreveport, LA

Shreveport, Louisiana, 71101-4243, United States

Location

Lebanon VA Medical Center, Lebanon, PA

Lebanon, Pennsylvania, 17042-7529, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

Cheyenne VA Medical, Cheyenne, WY

Cheyenne, Wyoming, 82001, United States

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Bekelman, MD MPH

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Bekelman, MD MPH

CONTACT

(720) 857-2809; david.bekelman@va.gov

Chelsea A Leonard, PhD

CONTACT

Chelsea.Leonard@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label pragmatic implementation trial. Blinding of participants, care providers, or investigators is not feasible given the nature of the behavioral intervention and implementation support conditions. However, sites are blinded to the different implementation support conditions.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Cluster-randomized stepped-wedge design with practice groups across 8 VA sites. Within each site, one practice group rolls out per wave across 6 waves beginning July, 2026, with waves occurring every 3 months. All sites follow the same sequential timeline; pre-implementation periods serve as within-site controls. Sites are additionally assigned in parallel to one of two implementation support conditions(standard or enhanced) using covariate-constrained randomization on rurality and site engagement level, allowing comparison of implementation support intensity across concurrently running sites. Both clinical effectiveness and implementation outcomes are compared across implementation support conditions.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): September 30, 2030
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)