Clinical trial NCT02966509: Engagement of Patients With Advanced Cancer
Official title: Engagement of Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End of Life
Advanced Cancer
Lung Neoplasm
Gastric Cancer
Colon Cancer
Glioblastoma Multiforme
Head and Neck Neoplasms
Rectum Cancer
Melanoma
Kidney Cancer
Prostate Cancer
Testicular Neoplasms
Liver Cancer
Cancer of Unknown Origin
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: VA Palo Alto Health Care System
First posted: 2016-11-17
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained lay health coaches to engage patients and their families in goals of care and shared decision-making after a diagnosis of advanced cancer. Although lay health workers have never been tested in this role, we hypothesize that lay health workers can feasibly improve goals of care documentation and help to reduce unwanted healthcare utilization at the end of life for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent disease.

Detailed description: VAPAHCS proposes to implement and evaluate several critical elements to be in alignment with the VHA's Strategic Goal and priority areas for FY2013. The Engagement of Patients with Advanced Cancer project is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Veterans with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals with advanced cancer who have advanced cancer (stages III, IV or recurrent disease). The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved patient experiences, outcomes, and that the program helps to reduce utilization of health care resources at the end of life.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed stage III or IV cancer
* Recurrent disease (any stage)
* Ability to consent to study

Exclusion Criteria:

* Patients who are unable to consent to study procedures

Primary outcomes:
measure: Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.
timeFrame: 6 months after each patient enrollment
Secondary outcomes:
measure: Emergency Department Visit (Chart Review)
timeFrame: 6 months after patient enrollment
measure: Emergency Department Visit (Chart Review)
timeFrame: 15 months after patient enrollment
measure: Hospitalization Visits (Chart Review)
timeFrame: 6 months after patient enrollment
measure: Hospitalization Visits (Chart Review)
timeFrame: 15 months after patient enrollment
measure: Hospice Referral (Chart Review)
timeFrame: 6 months after patient enrollment
measure: Palliative Care Referral (Chart Review)
timeFrame: 6 months after patient enrollment
measure: Palliative Care Referral (Chart Review)
timeFrame: 15 months after patient enrollment
measure: Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
timeFrame: Change in Patient Satisfaction with Care from baseline to 6 months.
measure: Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Patel MI, Sundaram V, Desai M, Periyakoil VS, Kahn JS, Bhattacharya J, Asch SM, Milstein A, Bundorf MK. Effect of a Lay Health Worker Intervention on Goals-of-Care Documentation and on Health Care Use, Costs, and Satisfaction Among Patients With Cancer: A Randomized Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1359-1366. doi: 10.1001/jamaoncol.2018.2446.