Algorithm-enabled Goals of Care Communication

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Usual Care
  Usual care or standard of care as per the clinical site in which participant is receiving cancer care.
• Поведенческое 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.

Первичные конечные точки

• Life Sustaining Treatment Documentation [Срок оценки: 3 months]

Вторичные конечные точки (6)

• Patient-reported Anxiety and Depression [Срок оценки: 3 months]
• Advance Directive Documentation [Срок оценки: 12 months]
• Acute Care Use [Срок оценки: 12 months]
• Life Sustaining Treatment Documentation [Срок оценки: 6 months]
• Life Sustaining Treatment Documentation [Срок оценки: 9 months]
• Life Sustaining Treatment Documentation [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• No capacity to consent
• Actively receiving hospice care

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto

Идентификаторы

NCT: NCT07690904 · HSR6-015-24W · 1-I01-RD-0000421-01-A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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