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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Usual Care + A-EPAC

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manali I Patel, MD MSPH; Phone Number: (650) 493-5000; Email: Manali.Patel2@va.gov

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304-1207
      • VA Palo Alto Health Care System, Palo Alto, CA
      • Contact: Madhuri Agrawal; Phone Number: 650-304-7744; Email: madhuri.agrawal@va.gov
      • Principal Investigator: Manali I Patel, MD MSPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Participants will receive usual cancer care for 12 months or until death whichever is first.	Behavioral: Usual Care; Usual care or standard of care as per the clinical site in which participant is receiving cancer care.; Other Names: 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.	Behavioral: Usual Care; Usual care or standard of care as per the clinical site in which participant is receiving cancer care.; Other Names: Standard of care, standard therapy; Behavioral: 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.; Other Names: Goals of Care Behavioral Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life Sustaining Treatment Documentation	Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Anxiety and Depression	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	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	Any hospitalization or emergency room admission within 12-months of follow-up.	12 months
Life Sustaining Treatment Documentation	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	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	Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family reported quality of end-of-life care	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	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	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	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	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	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	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:	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)	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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Manali I Patel, MD MSPH, VA Palo Alto Health Care System, Palo Alto, CA

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cancer
• Additional Relevant MeSH Terms: Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: HSR6-015-24W; 1-I01-RD-0000421-01-A1 (Other Grant/Funding Number: VA HSR&D eRA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No