Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a a lay health worker (LHW)-led symptom screening intervention was developed for patients with advanced cancer. This intervention will be expanded to all patients with cancer and the LHW will be trained to refer patients to palliative care and behavioral health. This intervention will evaluate the effect on symptom-burden, survival, healthcare use, and total costs.
From 11/1/2016 - 9/30/2018, all newly diagnosed Medicare Advantage enrollees with solid or hematologic malignancies were enrolled in the intervention. Outcomes were compared outcomes to patients in the year prior (control arm). The primary outcome was change in symptoms using the Edmonton Symptom Assessment Scale (ESAS) and Personal Health Questionnaire-9 (PHQ-9) at baseline, 6- and 12-months post-enrollment. Secondary outcomes were between-group comparison of survival, 12-month healthcare use and costs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
832
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
Oncology Institute for Hope and Innovation
Los Angeles, California, United States
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). 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).
Time frame: Baseline (at time of patient enrollment)
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). 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).
Time frame: 6 months after patient enrollment
Edmonton Symptom Assessment Scale (ESAS) Symptom Screen
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). 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).
Time frame: 12 months after patient enrollment
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at baseline. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.
Time frame: Baseline (at time of patient enrollment)
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at 6 months. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.
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Time frame: 6 months after patient enrollment
Personal Health Questionnaire-9 (PHQ-9) Depression Screen
Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at 12 months. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.
Time frame: 12 months after patient enrollment
Incidence of Emergency Department Visits Within 12-months After Patient Enrollment (Chart Review)
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 number of visits (per 1000 members/year) with emergency department visits between study arms.
Time frame: 12 months after patient enrollment
Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review)
Hospital 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 number of visits (per 1000 members/year) with hospital use between study arms.
Time frame: 12 months after patient enrollment
Number of Patients With a Hospice Consult Within 12-months After Patient Enrollment (Chart Review)
Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Time frame: 12 months after patient enrollment
Total Health Care Costs (Claims Review)
Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.
Time frame: 12 months after patient enrollment
Number of Patients With an Acute Care Facility Death (Chart Review)
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.
Time frame: 30 days prior to death for patients who died at 12-months follow-up
Number of Emergency Department Visit in the Last 30 Days of Life (Chart Review)
Emergency Department (acute care) 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.
Time frame: 30 days prior to death for patients who died at 12-months follow-up
Number of Hospitalization Visits in the Last 30 Days of Life (Chart Review)
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.
Time frame: 30 days prior to death for patients who died at 12-months follow-up
Number of Patients With a Hospice Consult in the Last 30 Days of Life (Chart Review)
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.
Time frame: 30 days prior to death for patients who died at 12-months follow-up
Total Costs of Care (Claims Review)
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.
Time frame: 30 days prior to death for patients who died at 12-months follow-up