The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.

Program participants

Rising costs and poor patient experiences from under-treated symptoms have led to the demand for approaches that improve patients' experiences and lower expenditures. This observational project assigned a lay health worker to concuct proactive symptom assessments intended to achieve these goals among patients with advanced cancer.

All newly diagnosed Medicare Advantage enrollees with Stage 3 or 4 solid tumors or hematologic malignancies who planned to receive all oncology care at the Oncology Institute of Hope and Innovation from 11/1/2015 through 9/30/2016 were enrolled in the program. The program consisted of a 12-month telephonic program in which a lay health worker (LHW) supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) with the frequency of symptom assessment varying based on patient risk. We evaluated feasibility, defined as monthly LHW documentation of symptom assessments, and change in patient-reported satisfaction and overall and emotional and mental health with validated assessments at enrollment and 5-months post-enrollment among patients in the intervention. We compared healthcare use and costs to a historical cohort of similar Medicare Advantage enrollees diagnosed between 11/1/2014-10/31/2015 (control). We assessed differences in demographic and clinical factors between the two groups using chi-square and t-tests and used generalized linear models to evaluate differences in healthcare use and costs.

Lay Health Worker Led Symptom Assessment Intervention

Joint Oncology Collaboration for Proactive Symptom Assessments by a Lay Health Worker

% of patients with at least monthly symptom assessments documented in the electronic health record for at least 12 months for until death

Emergency Department Use for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.

Hospitalization Use for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.

Intensive Care Unit Visits for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.

Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.

Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 5 months. We will measure the change in satisfaction from baseline to 5 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 12 months.

Stanford University

Assistant Professor

Symptoms and General Pathology

All Conditions

Death

Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months.

The control group arm will receive usual care as provided by their local oncologists.

The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.

Usual care as provided by local oncologists

Usual Care

Manali I Patel, MD MPH MS

Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was developed for patients with cancer. In pilot work, the intervention was associated with improvements in patient symptom burden and reductions in healthcare use and costs of care at the end of life. This intervention will be expanded across several clinics to evaluate the impact of the LHW intervention on with cancer and the LHW will be trained to refer patients to palliative care. This randomized intervention will evaluate the effect on healthcare use, total costs, palliative care and hospice referral.

All patients with newly diagnosed cancer, over the age of 75 will be randomized into the CareMore Pilot 2 Program with 200 randomized to the intervention grou and 200 randomized to the control group.

Lay Health Worker Expanded Intervention in Community Oncology Practices

Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of the % of patients with emergency department visits between study arms.

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospitalizations between the two study arms.

Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

Acute Care Facility Deaths for each patient will be abstracted by electronic medical record chart review and claims review for each patient who has died at 12-months followup. We will evaluate comparisons of Acute Care Facility Deaths between study arms.

Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of emergency department visits between study arms.

Hospital use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospitalization use between study arms.

Hospice use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospice use between study arms.

Total costs of care for each patient will be obtained through claims data for each patient for each patient who has died. We will evaluate comparisons of Total costs of care between study arms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lay Health Worker Led Symptom Assessment Intervention	NCT03737058	Cancer	Program partici...	-	Stanford University
Lay Health Worker Expanded Intervention in Community Oncology Practices	NCT04463992	End of Life Cancer	Program partici... Usual Care	75 Years - 100 Years	Stanford University
Lay Health Worker Led Symptom Assessment Intervention	NCT03737058	Cancer	Program partici...	-	Stanford University
Lay Health Worker Expanded Intervention in Community Oncology Practices	NCT04463992	End of Life Cancer	Program partici... Usual Care	75 Years - 100 Years	Stanford University

Spots Global Cancer Trial Database for program participants