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OpenTrials
Completed

NCT Number: NCT03737058

Lay Health Worker Led Symptom Assessment Intervention

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.

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Key information

Conditions

Cancer Neoplasms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

None

Treatment and study plan

Program participants

Behavioral

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.

Primary outcomes

  1. 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

  1. Incidence of Emergency Department Visits

    Time frame: 12 months after patient enrollment

    Emergency Department use for each patient abstracted from medical claims data review for each patient at 12 months after enrollment.

  2. Hospitalization Visits (Claims Review)

    Time frame: 12 months after patient enrollment

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

  3. Intensive Care Unit Visits (Claims Review)

    Time frame: 12 months after patient enrollment

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

  4. Total Health Care Costs (Claims Review)

    Time frame: 12 months after patient enrollment

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

  5. Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey

    Time frame: Change in Patient Satisfaction with Care from baseline to 5 months.

    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 calculated as the value at 5 months minus the baseline value. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2018
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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