[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07714252":3,"trial-entities:NCT07714252":235,"trial-summary:NCT07714252":239},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":62,"secondary_outcomes":67,"sex":92,"minimum_age":93,"maximum_age":94,"healthy_volunteers":15,"eligibility_criteria":95,"std_ages":108,"locations":111,"central_contacts":224,"overall_officials":231,"references":233,"see_also_links":234},"NCT07714252","QUX 26-007","Virtual Nurse and Social Worker Palliative Care Team to Improve Quality of Life in Veterans With Heart Failure or COPD","Addressing Symptoms With Person-Centered Treatment (ADAPT) (QUE 25-018)","NOT_YET_RECRUITING","2030-09-30","2026-07","2026-07-20","2026-08-01","VA Office of Research and Development","FED",false,"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.","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.\n\nThis 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.\n\nThe 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.\n\nPractice 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.\n\nIn 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.\n\nA 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.",[19,20,21],"Heart Failure","Pulmonary Disease, Chronic Obstructive","Interstitial Lung Disease",[23,24,25,26,27,28,29,30,31,32],"Palliative Care","Quality of Life","Veterans Health","Telemedicine","Social Work","Implementation Science","Symptom Management","Patient-Reported Outcomes","Motivational Interviewing","Nurses","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[36],"NA",{"count":38,"type":39},420,"ESTIMATED",[41,50,56],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":48},"BEHAVIORAL","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.",[46,47],"EBP + Enhanced Implementation Support","EBP + Standard Implementation Support",[49],"ADAPT intervention; palliative telecare team; nurse-social worker virtual team",{"type":42,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"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).",[46],[55],"Educational Outreach and Implementation Facilitation (enhanced)",{"type":42,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"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).",[47],[61],"Educational Outreach and Implementation Facilitation (standard)",[63],{"measure":64,"description":65,"timeFrame":66},"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\u002Ffamily, 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)",[68,72,75,78,82,86,89],{"measure":69,"description":70,"timeFrame":71},"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.","Every 6 months from Start of pre-implementation through end of sustainment phase, an average of 2.5 years",{"measure":73,"description":74,"timeFrame":71},"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.",{"measure":76,"description":77,"timeFrame":71},"Suicidality - Columbia Suicide Severity Rating Scale (C-SSRS)","Veteran-reported assessment of suicidal ideation and behavior severity.",{"measure":79,"description":80,"timeFrame":81},"Documentation of Goals and Preferences\u002FLife-Sustaining Treatment Note","Binary indicator of goals and preferences\u002Flife-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)",{"measure":83,"description":84,"timeFrame":85},"All-Cause Mortality","Death from any cause, ascertained from the VA Death Ascertainment File.","1 year after Veteran enrollment",{"measure":87,"description":88,"timeFrame":85},"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).",{"measure":90,"description":91,"timeFrame":85},"Hospice Utilization","Time to first hospice enrollment, ascertained from VA inpatient records.","ALL","18 Years",null,{"inclusion":96,"exclusion":102,"raw_text":107},[97,98,99,100,101],"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",[103,104,105,106],"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\u002Falcohol 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)","Inclusion Criteria:\n\n* At least one primary care encounter in the past year, identified by primary care stop codes (301, 322, 323, 342, 348, 350, 704)\n* 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\n* Care Assessment Need (CAN) 3.0 score ≥ 90 at some point in the prior 6 months\n* Poor self-reported quality of life, defined as a FACT-G score ≤ 70 at screening\n* Consistent access to a telephone\n\nExclusion Criteria:\n\n* Dementia diagnosis (any inpatient, outpatient, or community care encounter with qualifying ICD code in the prior 3 years)\n* 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)\n* Current substance misuse (at least 1 inpatient or outpatient encounter with a qualifying substance\u002Falcohol ICD code or stop code in the prior 6 months)\n* Currently receiving palliative care (at least 1 inpatient or outpatient encounter with palliative care stop codes 351 or 353 in the prior 1 year)",[109,110],"ADULT","OLDER_ADULT",[112,129,144,164,179,194,209],{"facility":113,"city":114,"state":115,"zip":116,"country":117,"contacts":118,"geoPoint":126},"Phoenix VA Health Care System, Phoenix, AZ","Phoenix","Arizona","85012","United States",[119,123],{"name":120,"role":121,"email":122},"Krystle Johnson-Reed, RN","CONTACT","krystle.johnson-reed@va.gov",{"name":124,"role":121,"email":125},"Donna Seton, PA-C","donna.seton@va.gov",{"lat":127,"lon":128},33.44838,-112.07404,{"facility":130,"city":131,"state":132,"zip":133,"country":117,"contacts":134,"geoPoint":141},"VA Long Beach Healthcare System, Long Beach, CA","Long Beach","California","90822",[135,138],{"name":136,"role":121,"email":137},"Donna Sheehan, RN","donna.sheehan@va.gov",{"name":139,"role":121,"email":140},"Rebecca Yamarik, MD","rebecca.yamarik@va.gov",{"lat":142,"lon":143},33.76696,-118.18923,{"facility":145,"city":146,"state":147,"zip":148,"country":117,"contacts":149,"geoPoint":161},"Rocky Mountain Regional VA Medical Center, Aurora, CO","Aurora","Colorado","80045-7211",[150,154,158],{"name":151,"role":121,"phone":152,"email":153},"Pamela Rice, PhD","720-218-4015","Pamela.Rice@va.gov",{"name":155,"role":121,"phone":156,"email":157},"James P Hill","(720) 830-7685","James.Hill5@va.gov",{"name":159,"role":160},"David Bekelman, MD MPH","PRINCIPAL_INVESTIGATOR",{"lat":162,"lon":163},39.72943,-104.83192,{"facility":165,"city":166,"state":167,"zip":168,"country":117,"contacts":169,"geoPoint":176},"Overton Brooks VA Medical Center, Shreveport, LA","Shreveport","Louisiana","71101-4243",[170,173],{"name":171,"role":121,"email":172},"Stephanie Branch, RN","stephanie.branch@va.gov",{"name":174,"role":121,"email":175},"Marilyn Latin, MD","Marilyn.Latin@va.gov",{"lat":177,"lon":178},32.52515,-93.75018,{"facility":180,"city":181,"state":182,"zip":183,"country":117,"contacts":184,"geoPoint":191},"Lebanon VA Medical Center, Lebanon, PA","Lebanon","Pennsylvania","17042-7529",[185,188],{"name":186,"role":121,"email":187},"Melissa Buchinski, RN","melissa.buchinski@va.gov",{"name":189,"role":121,"email":190},"Rachel Causak, MD","Rachel.Causak@va.gov",{"lat":192,"lon":193},40.34093,-76.41135,{"facility":195,"city":196,"state":197,"zip":198,"country":117,"contacts":199,"geoPoint":206},"Providence VA Medical Center, Providence, RI","Providence","Rhode Island","02908-4734",[200,203],{"name":201,"role":121,"email":202},"Patrician Lamarre, RN","patricia.lamarre@va.gov",{"name":204,"role":121,"email":205},"Mitchell Wice, MD","mitchell.wice2@va.gov",{"lat":207,"lon":208},41.82399,-71.41283,{"facility":210,"city":211,"state":212,"zip":213,"country":117,"contacts":214,"geoPoint":221},"Cheyenne VA Medical, Cheyenne, WY","Cheyenne","Wyoming","82001",[215,218],{"name":216,"role":121,"email":217},"Erin Kramer, RN","erin.kramer@va.gov",{"name":219,"role":121,"email":220},"Jannene Sebesta, MD","jannene.sebesta@va.gov",{"lat":222,"lon":223},41.13998,-104.82025,[225,228],{"name":159,"role":121,"phone":226,"email":227},"(720) 857-2809","david.bekelman@va.gov",{"name":229,"role":121,"email":230},"Chelsea A Leonard, PhD","Chelsea.Leonard@va.gov",[232],{"name":159,"affiliation":145,"role":160},[],[],{"nct_id":4,"conditions":236,"biomarkers":238},[237,19,21],"Chronic Obstructive Pulmonary Disease",[],{"nct_id":4,"found":240,"summary":241,"prompt_version":251},true,{"design":242,"status":243,"heading":244,"summary":245,"follow_up":246,"word_count":247,"commitments":248,"compensation":249,"drugs_mentioned":250},"This is an interventional study with a planned enrollment of 420 participants. It compares a virtual nurse and social worker palliative care team with enhanced or standard implementation support.","completed","Virtual Nurse and Social Worker Palliative Care for Veterans with Heart Failure or COPD","This study is testing if a virtual team of a nurse and social worker can improve the quality of life for Veterans with heart failure (a condition where the heart can't pump enough blood) or chronic obstructive pulmonary disease (COPD, a group of lung diseases that block airflow and make it hard to breathe). Many Veterans with these conditions experience symptoms like breathlessness, fatigue, depression, and anxiety. The virtual team will provide direct care by phone or video, with the nurse helping manage symptoms and the social worker offering counseling. The study aims to see if this approach improves overall quality of life, depression, and anxiety. You might be able to join if you are a Veteran aged 18 or older, have had a primary care visit in the last year, and have been diagnosed with heart failure, COPD, or interstitial lung disease (a group of lung diseases that cause scarring of lung tissue). The study is currently recruiting 420 participants.","Your health-related quality of life will be assessed every 6 months from pre-implementation through sustainment, which can be up to approximately 30 months.",161,"Your quality of life will be assessed every 6 months from before the study starts through a sustainment period of up to approximately 30 months. The main comparison of effectiveness will be at the end of your intervention period, which is about 4-6 months after you join.","Not stated in the trial record.",[],"v2"]