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)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85012
- Phoenix VA Health Care System, Phoenix, AZ
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California
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Long Beach、California、アメリカ、90822
- VA Long Beach Healthcare System, Long Beach, CA
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Colorado
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Aurora、Colorado、アメリカ、80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Louisiana
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Shreveport、Louisiana、アメリカ、71101-4243
- Overton Brooks VA Medical Center, Shreveport, LA
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Pennsylvania
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Lebanon、Pennsylvania、アメリカ、17042-7529
- Lebanon VA Medical Center, Lebanon, PA
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Rhode Island
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Providence、Rhode Island、アメリカ、02908-4734
- Providence VA Medical Center, Providence, RI
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Wyoming
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Cheyenne、Wyoming、アメリカ、82001
- Cheyenne VA Medical, Cheyenne, WY
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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).
他の名前：
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.
他の名前：
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実験的：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.
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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).
他の名前：
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.
他の名前：
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Health-Related Quality of Life - Functional Assessment of Chronic Illness Therapy-General (FACT-G) Total Score
時間枠：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)
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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.
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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)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Depression - Patient Health Questionnaire-8 (PHQ-8)
時間枠：Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years
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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.
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Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years
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Anxiety - Generalized Anxiety Disorder-7 (GAD-7)
時間枠：Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years
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Veteran-reported 7-item anxiety symptom scale.
Scores range from 0 to 21; higher scores indicate greater anxiety severity.
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Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years
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Suicidality - Columbia Suicide Severity Rating Scale (C-SSRS)
時間枠：Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years
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Veteran-reported assessment of suicidal ideation and behavior severity.
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Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years
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Documentation of Goals and Preferences/Life-Sustaining Treatment Note
時間枠：Baseline (any prior documentation) and at 6 and 12 months after Veteran enrollment (any new or updated documentation during follow-up)
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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.
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Baseline (any prior documentation) and at 6 and 12 months after Veteran enrollment (any new or updated documentation during follow-up)
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All-Cause Mortality
時間枠：1 year after Veteran enrollment
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Death from any cause, ascertained from the VA Death Ascertainment File.
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1 year after Veteran enrollment
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All-Cause Hospitalization
時間枠：1 year after Veteran enrollment
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Any unplanned VA or VA-paid community hospitalization, ascertained from the VA Corporate Data Warehouse (inpatient) and Consolidated Data Set (community care).
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1 year after Veteran enrollment
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Hospice Utilization
時間枠：1 year after Veteran enrollment
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Time to first hospice enrollment, ascertained from VA inpatient records.
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1 year after Veteran enrollment
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reach - Proportion of Eligible Veterans Enrolled
時間枠：Assessed per implementation wave through end of implementation phase(approximately 18 months from Wave 1 start)
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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.
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Assessed per implementation wave through end of implementation phase(approximately 18 months from Wave 1 start)
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Fidelity - Proportion of Intervention Modules Completed
時間枠：Start through end of implementation phase, an average of 1.5 years
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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.
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Start through end of implementation phase, an average of 1.5 years
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Adoption - Proportion of Practice Groups Implementing the Intervention as Planned
時間枠：Start through end of implementation phase, an average of 1.5 years
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Number and proportion of practice groups that adopt and deliver the intervention, compared across standard and enhanced implementation support sites.
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Start through end of implementation phase, an average of 1.5 years
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Sustainment - Intent to Maintain Program at End of Implementation Phase
時間枠：End of implementation phase (approximately 18 months after Wave 1 start)
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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.
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End of implementation phase (approximately 18 months after Wave 1 start)
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Cost of implementation
時間枠：Start through end of implementation phase, an average of 1.5 years
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costs of replication for new settings, delivery of implementation strategies, delivery of intervention
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Start through end of implementation phase, an average of 1.5 years
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Effectiveness - Costs of Care
時間枠：Start through end of implementation phase, an average of 1.5 years
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In-patient hospitalizations, outpatient care Emergency Department (ED), hospice utilization and costs (VA-delivered and VA-purchased)
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Start through end of implementation phase, an average of 1.5 years
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協力者と研究者
捜査官
- 主任研究者：David Bekelman, MD MPH、Rocky Mountain Regional VA Medical Center, Aurora, CO
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- QUX 26-007
- QUE 25-018 (その他の助成金/資金番号：VA Quality Enhancement Research Initiative (QUERI))
- QUX 26-006 (VA Quality Enhancement Research Initiative (QUERI))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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