Cancer
Conditions
Keywords
Cancer
Brief summary
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.
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.
Interventions
BEHAVIORALUsual Care
Usual care or standard of care as per the clinical site in which participant is receiving cancer care.
BEHAVIORALUsual Care + A-EPAC
Educational and support intervention for participants regarding goals of care discussions and engagement in these topics with a lay health worker.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel randomization at the participant-level
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Life Sustaining Treatment Documentation | 3 months | Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Anxiety and Depression | 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. |
| Advance Directive Documentation | 12 months | Proportion of participants with any advance directive documentation in the electronic health record between baseline and 12 months follow-up. |
| Acute Care Use | 12 months | Any hospitalization or emergency room admission within 12-months of follow-up. |
| Life Sustaining Treatment Documentation | 6 months | Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record. |
Countries
United States
Contacts
CONTACTManali I Patel, MD MSPH
PRINCIPAL_INVESTIGATORManali I Patel, MD MSPH
VA Palo Alto Health Care System, Palo Alto, CA
Outcome results
None listed