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| ID | Type | Description | Link |
|---|---|---|---|
| 1-I01-RD-0000421-01-A1 | Other Grant/Funding Number | VA HSR&D eRA |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Participants will receive usual cancer care for 12 months or until death whichever is first. |
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| Usual Care + A-EPAC | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Behavioral | Usual care or standard of care as per the clinical site in which participant is receiving cancer care. |
|
| 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 |
| 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 |
| 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. |
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
CAN risk score ≥98th percentile (may be adjusted after examining site-level CAN performance)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manali I Patel, MD MSPH | Contact | (650) 493-5000 | Manali.Patel2@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Manali I Patel, MD MSPH | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Parallel randomization at the participant-level
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| Usual Care + A-EPAC | Behavioral | Educational and support intervention for participants regarding goals of care discussions and engagement in these topics with a lay health worker. |
|
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| 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 |
| 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
| 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 |