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Algorithm-enabled Goals of Care Communication (A-EPAC)

27 de julio de 2026 actualizado por: VA Office of Research and Development

Algorithm-Enabled Engagement of Patients With Advanced Cancer (A-EPAC) to Improve Goals of Care Communication Among Veterans With Advanced Stages of Cancer

In 2017, the VA launched the Life-Sustaining Treatment Decisions Initiative (LSTDI), a national program to promote Goals of Care communication between clinicians and patients regarding goals and preferences for care. Despite clinician training and standardized Life Sustaining Treatment (LST) notes in the electronic health record (EHR), 60% of Veterans with cancer have not engaged in such communication with their oncology clinicians before death. Over the past 10 years, the team developed and tested: 1) a lay health worker-led intervention to improve these conversations and reduce unwanted, intensive end-of-life care, and 2) an algorithm-driven approach to identify patients in need of urgent conversations with their clinical teams. This randomized study will evaluate the effectiveness of an intervention combining these two approaches across 7 VA oncology sites. The outcomes include LST documentation, Veteran-reported anxiety and depression, and the identification of factors to inform broad scale of Veteran-centric interventions to improve GoC communication.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

The investigators developed the Engagement of Patients with Advanced Cancer (EPAC) intervention - a 6-month telephone-based intervention in which trained lay health workers (LHWs) educate and empower Veterans with cancer to engage in goals of care conversations with their oncology clinical teams. To facilitate scale, the investigator propose Algorithm-Enabled EPAC (A-EPAC), which uses the VA Care Assessment Needs (CAN) score to automatically identify patients with cancer who could benefit from EPAC. This intent-to-treat randomized trial is conducted in collaboration with the NTO and the National VA Oncology Programs (NOP). The investigators will randomize 200 Veterans with cancer receiving care across 7 VA facilities to either the A-EPAC intervention (algorithm-based identification and referral to EPAC for 6-months) or usual cancer care alone (cancer care provided by oncology teams at the local site). Participants will be followed for 12-months post enrollment. The primary outcome is Life Sustaining Treatment documentation at 3 months post-enrollment. Secondary outcomes are patient anxiety and depression at 3 months measured by PROMIS® short forms. Exploratory outcomes include intensive end-of-life care, advance directive documentation, and acute care use. Using a quant-qual framework, the investigators will conduct validated surveys with 40 Veterans with cancer and Veteran and clinician interviews at 6 months to identify factors associated with feasibility, adoption, acceptability, and A-EPAC fidelity.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Manali I Patel, MD MSPH
  • Número de teléfono: (650) 493-5000
  • Correo electrónico: Manali.Patel2@va.gov

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Palo Alto, California, Estados Unidos, 94304-1207
        • VA Palo Alto Health Care System, Palo Alto, CA
        • Investigador principal:
          • Manali I Patel, MD MSPH
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Veteran patients with diagnosis of a solid malignancy with any cancer stage
  • English or Spanish-speaking
  • Can self-administer questionnaires in English or Spanish
  • Valid telephone number
  • Receiving oncology care at one of 7 sites

  • Receiving systemic anti-cancer therapy, defined as oral, injection, or intravenous therapy

    • chemotherapy
    • hormone therapy
    • targeted therapy
    • or immunotherapy defined by the National Cancer Institute A to Z List of Cancer Drugs)
  • CAN risk score ≥98th percentile (may be adjusted after examining site-level CAN performance)

Exclusion Criteria:

  • No capacity to consent
  • Actively receiving hospice care

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Usual Care
Participants will receive usual cancer care for 12 months or until death whichever is first.
Conductual: Usual Care
Usual care or standard of care as per the clinical site in which participant is receiving cancer care.
Otros nombres:
  • Standard of care, standard therapy
Experimental: Usual Care + A-EPAC
Participants will be assigned to a lay health worker who will conduct education sessions over 30-45 minutes by phone initially followed by 15 minute conversations twice monthly for 6 months to discuss goals of care and how to engage in these discussions with their clinical teams. Participants will also receive usual cancer care for a total of 12 months or until death, whichever is first.
Conductual: Usual Care
Usual care or standard of care as per the clinical site in which participant is receiving cancer care.
Otros nombres:
  • Standard of care, standard therapy
Conductual: Usual Care + A-EPAC
Educational and support intervention for participants regarding goals of care discussions and engagement in these topics with a lay health worker.
Otros nombres:
  • Goals of Care Behavioral Intervention

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Life Sustaining Treatment Documentation
Periodo de tiempo: 3 months
Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.
3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient-reported Anxiety and Depression
Periodo de tiempo: 3 months
Change in mean score using the validated PROMIS Short Form v1.0 of Anxiety 4a and Depression 4a between time of enrollment and 3 months post-enrollment. Each scale consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater symptom severity. That is - higher score represents a worse outcome.
3 months
Advance Directive Documentation
Periodo de tiempo: 12 months
Proportion of participants with any advance directive documentation in the electronic health record between baseline and 12 months follow-up.
12 months
Acute Care Use
Periodo de tiempo: 12 months
Any hospitalization or emergency room admission within 12-months of follow-up.
12 months
Life Sustaining Treatment Documentation
Periodo de tiempo: 6 months
Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.
6 months
Life Sustaining Treatment Documentation
Periodo de tiempo: 9 months
Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.
9 months
Life Sustaining Treatment Documentation
Periodo de tiempo: 12 months
Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.
12 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Family reported quality of end-of-life care
Periodo de tiempo: 12 months
For participants who die during the study period, the VA Veterans Experience Center will administer the Bereaved Family Survey which solicits bereaved family evaluations of care in the last 30 days of life. One component of this survey is the National Quality Forum-endorsed measure called the BFS Performance Measure (BFS-PM), a single item evaluation of the overall quality of EOL care. This measure is measured a 5-point Likert scale, which investigators will dichotomize as "excellent" vs all other categories. This measure will be reported out descriptively.
12 months
Heard and Understood
Periodo de tiempo: 3 months
Descriptive measure using the National Quality Forum 4-item survey which assesses perceptions of quality of communication with the clinical team.
3 months
Proportion of patients with Intensive End of life Care
Periodo de tiempo: 12 months

Number of participants who die within 12-months of follow-up who had any

  • hospital or Intensive Care Unit admission <30 days before death,
  • receipt of any systemic therapy <14 days before death (defined as both oral and intravenous chemotherapy and immunotherapy),
  • hospice referral <3 days before death. (abstracted from electronic health record)
12 months
Acceptability
Periodo de tiempo: 6 months
Investigators will measure patient-reported acceptability using the 12-item validated Acceptability of Intervention Measure (AIM) (Veterans or designated caregivers)
6 months
Beliefs about GoC communication
Periodo de tiempo: 6 months
Beliefs related to GoC communication (e.g., self-efficacy and readiness) will be measured using the 15-item validated Advance Care Planning Engagement survey (Veterans or designated caregivers), which has been validated in diverse populations of outpatients with advanced cancer. Beliefs related to GoC communication will be assessed using the 28-item validated End-of-Life Care Questionnaire (EOL-Q) (clinicians, LHW)
6 months
Patient-Centered Care 1
Periodo de tiempo: 6 months
Patient-clinician communication will be measured among patients using validated communication items from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) (Veterans or designated caregivers).
6 months
Patient-Centered Care 2
Periodo de tiempo: 6 months
Patient engagement will be measured using a 4-item measure of shared decision making (SDM Process-4) (Veterans or designated caregivers)
6 months
Organizational Climate:
Periodo de tiempo: 6 months
Investigators will administer the 18-item validated Implementation Climate Scale to capture degree to which the clinic supports use of GoC communication (clinicians, LHW)
6 months
Pragmatic Context Assessment Tool (pCAT)
Periodo de tiempo: 6 months
Investigators will administer a 14-item tool to assess barriers and facilitators to A-EPAC within the CFIR framework (Veterans or designated caregivers, clinician, LHW)
6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

VA Office of Research and Development

Investigadores

  • Investigador principal: Manali I Patel, MD MSPH, VA Palo Alto Health Care System, Palo Alto, CA

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de septiembre de 2026

Finalización primaria (Estimado)

30 de junio de 2031

Finalización del estudio (Estimado)

30 de junio de 2031

Fechas de registro del estudio

Enviado por primera vez

22 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de julio de 2026

Publicado por primera vez (Actual)

8 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HSR6-015-24W
  • 1-I01-RD-0000421-01-A1 (Otro número de subvención/financiamiento: VA HSR&D eRA)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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