Clinical trial NCT03737058: Lay Health Worker Led Symptom Assessment Intervention
Official title: Joint Oncology Collaboration for Proactive Symptom Assessments by a Lay Health Worker
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 288
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have a diagnosis of stage 3 and 4 cancers and who are receiving care at the Oncology Institute of Hope and Innovation and have CareMore Medicare Advantage as their healthcare payer plan.

Brief summary: 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 conduct proactive symptom assessments intended to achieve these goals among patients with advanced cancer.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of stage 3 and 4 cancer
2. Clinical diagnosis of hematologic malignancy
3. Must receive care at the Oncology Institute of Hope and Innovation
4. Must be an enrollee of CareMore Medicare Advantage

Exclusion Criteria:

None

Primary outcomes:
measure: Edmonton Symptom Assessment Scale Score (ESAS)
timeFrame: 12 months after patient enrollment
Secondary outcomes:
measure: Incidence of Emergency Department Visits
timeFrame: 12 months after patient enrollment
measure: Hospitalization Visits (Claims Review)
timeFrame: 12 months after patient enrollment
measure: Intensive Care Unit Visits (Claims Review)
timeFrame: 12 months after patient enrollment
measure: Total Health Care Costs (Claims Review)
timeFrame: 12 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 5 months.
Other outcomes:
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