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Clinical Trials/NCT03737058
NCT03737058
Completed
Not Applicable

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

Stanford University0 sites288 target enrollmentNovember 1, 2015
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Stanford University
Enrollment
288
Primary Endpoint
Edmonton Symptom Assessment Scale Score (ESAS)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2015
End Date
December 30, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Manali Indravadan Patel

Assistant Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Edmonton Symptom Assessment Scale Score (ESAS)

Time Frame: 12 months after patient enrollment

ESAS measures participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).

Secondary Outcomes

  • Incidence of Emergency Department Visits(12 months after patient enrollment)
  • Hospitalization Visits (Claims Review)(12 months after patient enrollment)
  • Intensive Care Unit Visits (Claims Review)(12 months after patient enrollment)
  • Total Health Care Costs (Claims Review)(12 months after patient enrollment)
  • Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey(Change in Patient Satisfaction with Care from baseline to 5 months.)

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