Heart FailureVITALVET:ADAPTNCT07714252
Virtual Nurse and Social Worker Palliative Care Team to Improve Quality of Life in Veterans With Heart Failure or COPD
A study testing Virtual Nurse and Social Worker Palliative Care Team, Enhanced Implementation Support and Standard Implementation Support in people with Heart Failure and Pulmonary Disease, Chronic Obstructive, run by VA Office of Research and Development at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Interstitial Lung Disease
- What is being tested?
- Virtual Nurse and Social Worker Palliative Care Team, Enhanced Implementation Support and Standard Implementation Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Aug 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Cheyenne VA Medical, Cheyenne, WY
Cheyenne, Wyoming, 82001
Lebanon VA Medical Center, Lebanon, PA
Lebanon, Pennsylvania, 17042-7529
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
Overton Brooks VA Medical Center, Shreveport, LA
Shreveport, Louisiana, 71101-4243
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Virtual Nurse and Social Worker Palliative Care Team, Enhanced Implementation Support, Standard Implementation Support
- Keywords
- Palliative Care, Quality of Life, Veterans Health, Telemedicine, Social Work, Implementation Science, Symptom Management, Patient-Reported Outcomes, Motivational Interviewing, Nurses
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Nurse and Social Worker Palliative Care TeamBehavioural
Also called ADAPT intervention; palliative telecare team; nurse-social worker virtual team
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.
Enhanced Implementation SupportBehavioural
Also called Educational Outreach and Implementation Facilitation (enhanced)
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).
Standard Implementation SupportBehavioural
Also called Educational Outreach and Implementation Facilitation (standard)
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
Veteran-reported 7-item anxiety symptom scale. Scores range from 0 to 21; higher scores indicate greater anxiety severity.
Measured: 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)
Veteran-reported assessment of suicidal ideation and behavior severity.
Measured: 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
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.
Measured: Baseline (any prior documentation) and at 6 and 12 months after Veteran enrollment (any new or updated documentation during follow-up)
All-Cause Mortality
Death from any cause, ascertained from the VA Death Ascertainment File.
Measured: 1 year after Veteran enrollment
All-Cause Hospitalization
Any unplanned VA or VA-paid community hospitalization, ascertained from the VA Corporate Data Warehouse (inpatient) and Consolidated Data Set (community care).
Measured: 1 year after Veteran enrollment
Hospice Utilization
Time to first hospice enrollment, ascertained from VA inpatient records.
Measured: 1 year after Veteran enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start6 Aug 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David Bekelman, MD MPH, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714252
- Sponsor's protocol ID
- QUX 26-007
- Other IDs
- QUE 25-018, QUX 26-006
- Acronym
- VITALVET:ADAPT
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Symptoms With Person-Centered Treatment (ADAPT) (QUE 25-018)
- ClinicalTrials.gov ID
- NCT07714252
- Acronym / sponsor ID
- VITALVET:ADAPT / QUX 26-007
- Keywords
- Palliative Care, Quality of Life, Veterans Health, Telemedicine, Social Work, Implementation Science, Symptom Management, Patient-Reported Outcomes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| EBP + Enhanced Implementation Support | Experimental | Behavioral: Virtual Nurse and Social Worker Palliative Care Team, Behavioral: Enhanced Implementation SupportFour 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. |
| EBP + Standard Implementation Support | Experimental | Behavioral: Virtual Nurse and Social Worker Palliative Care Team, Behavioral: Standard Implementation SupportFour 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. |
| 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Nurse and Social Worker Palliative Care TeamAlso: ADAPT intervention; palliative telecare team; nurse-social worker virtual teamA 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. | Behavioural | EBP + Enhanced Implementation Support, EBP + Standard Implementation Support |
| Enhanced Implementation SupportAlso: Educational Outreach and Implementation Facilitation (enhanced)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). | Behavioural | EBP + Enhanced Implementation Support |
| Standard Implementation SupportAlso: Educational Outreach and Implementation Facilitation (standard)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). | Behavioural | EBP + Standard Implementation Support |
Primary outcome
Health-Related Quality of Life - Functional Assessment of Chronic Illness Therapy-General (FACT-G) Total Score
Time frame: 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.
7 secondary outcomes
Depression - Patient Health Questionnaire-8 (PHQ-8)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline (any prior documentation) and at 6 and 12 months after Veteran enrollment (any new or updated documentation during follow-up)
All-Cause Mortality
Time frame: 1 year after Veteran enrollment
All-Cause Hospitalization
Time frame: 1 year after Veteran enrollment
Hospice Utilization
Time frame: 1 year after Veteran enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Bekelman, MD MPH principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Nurse and Social Worker Palliative Care Team, Enhanced Implementation Support and Standard Implementation Support in people with Heart Failure and Pulmonary Disease, Chronic Obstructive, run by VA Office of Research and Development at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life - Functional Assessment of Chronic Illness Therapy-General (FACT-G) Total Score (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.