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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Edmonton Symptom Assessment Scale Score (ESAS) | 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). | 12 months after patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Emergency Department Visits | Emergency Department use for each patient abstracted from medical claims data review for each patient at 12 months after enrollment. | 12 months after patient enrollment |
| Hospitalization Visits (Claims Review) |
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Inclusion Criteria:
Exclusion Criteria:
None
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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.
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Patients were excluded from the intervention and control groups if they did not require medical oncology services.
The study was implemented with CareMore Health and the Oncology Institute of Hope and Innovation, which has 26 locations across southern California. Enrollment was conducted between November 1, 2015 and September 30, 2016. Each patient participated for 12 months or until death, whichever occurred first.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics. |
| FG001 | Intervention Group | The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All newly diagnosed Medicare Advantage enrollees with stage 3 or 4 solid tumors or hematologic malignancies who were receiving care in a community oncology practice.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics. |
| BG001 | Intervention Group | The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Edmonton Symptom Assessment Scale Score (ESAS) | 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). | Only participants in the intervention group were invited to complete the ESAS. | Posted | Mean | Full Range | score on a scale | 12 months after patient enrollment |
|
Adverse event data were collected between time of enrollment and 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics. |
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The study was limited to one community oncology practice and to a Medicare Advantage population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manali I Patel, MD MPH MS | Stanford University School of Medicine | 650-723-4000 | manalip@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2018 | Jan 23, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Hospitalization Use for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.
| 12 months after patient enrollment |
| Intensive Care Unit Visits (Claims Review) | Intensive Care Unit Visits for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment. | 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. | 12 months after patient enrollment |
| Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | 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. | Change in Patient Satisfaction with Care from baseline to 5 months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Cancer Diagnosis | Count of Participants | Participants |
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| Cancer Stage | Cancer stages: stage 0 - the cancer is where it started (in situ) and hasn't spread; stage 1 - the cancer is small and hasn't spread anywhere else; stage 2 - the cancer has grown, but hasn't spread; stage 3 - the cancer is larger and may have spread to the surrounding tissues and/or the lymph nodes (or "glands", part of the immune system); stage 4 - the cancer has spread from where it started to at least 1 other body organ, also known as "secondary" or "metastatic" cancer. Stage was abstracted through chart review of clinical notes documented in the electronic health record by the oncologist. | Count of Participants | Participants |
|
| Intervention Group |
The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis. |
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| Secondary | Incidence of Emergency Department Visits | Emergency Department use for each patient abstracted from medical claims data review for each patient at 12 months after enrollment. | Posted | Number | visits per 1000 members/yr. | 12 months after patient enrollment |
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| Secondary | Hospitalization Visits (Claims Review) | Hospitalization Use for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment. | Posted | Mean | Standard Deviation | number of visits | 12 months after patient enrollment |
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| Secondary | Intensive Care Unit Visits (Claims Review) | Intensive Care Unit Visits for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment. | Posted | Mean | Standard Deviation | number of visits | 12 months after patient enrollment |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | $USD | 12 months after patient enrollment |
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| Secondary | Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | 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. | Posted | Mean | Standard Deviation | score on a scale | Change in Patient Satisfaction with Care from baseline to 5 months. |
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| 29 |
| 102 |
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| 102 |
| 0 |
| 102 |
| EG001 | Intervention Group | The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis. | 73 | 186 | 0 | 186 | 0 | 186 |
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| Change at 5-months |
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