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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group Arm | Experimental | Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. |
|
| Control Group Arm | Active Comparator | The control group arm will receive usual care as provided by their local oncologists. |
|
| 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 (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). | 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). | 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). | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after patient enrollment |
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Inclusion Criteria:
Exclusion Criteria:
-Inability to consent to the study due to lack of capacity as documented by the referring physician.
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| Name | Affiliation | Role |
|---|---|---|
| Manali I Patel, MD MPH MS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute for Hope and Innovation | Los Angeles | California | United States |
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One oncology clinic was excluded due to involvement in a previously reported intervention in the sources. The study also excluded clinic patients that did not receive medical oncology care.
The study was conducted with participants care for in 9 of 10 oncology clinics within the Oncology Institute of Hope and Innovation. Participants were screened by a new patient coordinator, then enrolled from 11/1/2016 to 10/31/2017 and were followed up with for 12 months after or death.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group Arm | Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: 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: Usual care as provided by local oncologists |
| FG001 | Control Group Arm | The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Amongst the 832 participants, 6 baseline characteristics were measured between the intervention and control arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group Arm | Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: 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: Usual care as provided by local oncologists |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The total participant population was broken down into each of the 9 individual clinic sites, and then analyzed. |
| 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 (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). | Posted | Mean | Full Range | total score on a scale | Baseline (at time of patient enrollment) |
|
The time frame over which the adverse data were collected were from time of enrollment until 1 year after enrollment.
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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 | Intervention Group Arm | Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months. Program participants: 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: Usual care as provided by local oncologists |
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Patients in the intervention group were compared with a retrospective cohort of patients; the practice setting was limited to 9 clinics associated with one institution; there may be differences in unmeasured variables, which would bias the findings; could not measure the physician assistant interventions made in response to symptoms. Could not assess the result of the intervention on intermediary variables due to only collecting data on palliative care and behavioral health.
| 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 | Nov 16, 2016 | Jan 23, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003643 | Death |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Usual Care | Other | Usual care as provided by local oncologists |
|
| 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. | 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. | 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. | 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 |
| 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. | 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. | 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. | 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. | 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. | 30 days prior to death for patients who died at 12-months follow-up |
| BG001 | Control Group Arm | The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The total participant population was broken down into each of the 9 individual clinic sites, and then analyzed. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The total participant population was broken down into each of the 9 individual clinic sites, and then analyzed. | Count of Participants | Participants |
|
| Cancer diagnosis | The total participant population was broken down into each of the 9 individual clinic sites, and then analyzed. | Count of Participants | Participants |
|
| 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. | The total participant population was broken down into each of the 9 individual clinic sites, and then analyzed. | Count of Participants | Participants |
|
| Risk Adjustment Factor | Risk Adjustment Factor (RAF) score range from 0 to no maximum value. Scores above 1.0 are considered high risk: RAF score range: RAF scores typically range from 0.6 to 1.2. A score of 1.0 is average, with decimal places representing percentages above or below average. A score above 1.0 indicates a higher risk of illness, while a score below 1.0 indicates a lower risk.RAF scores are used to calculate payments to healthcare organizations. RAF scores are based on a patient's disease burden and demographic information, adjusted for age, sex, and regionally based on costs of care. | The total participant population was broken down into each of the 9 individual clinic sites, and then analyzed. | Mean | Standard Deviation | Risk Adjustment Factor Score |
|
| OG001 | Control Group Arm | The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists |
|
|
| Primary | 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). | Posted | Mean | Full Range | score on a scale | 6 months after patient enrollment |
|
|
|
| Primary | 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). | Posted | Mean | Full Range | score on a scale | 12 months after patient enrollment |
|
|
|
| Primary | 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. | Posted | Mean | Full Range | units on a scale | Baseline (at time of patient enrollment) |
|
|
|
| Primary | 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. | Posted | Mean | Full Range | score on a scale | 6 months after patient enrollment |
|
|
|
| Primary | 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. | Posted | Mean | Full Range | score on a scale | 12 months after patient enrollment |
|
|
|
| Secondary | 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. | Posted | Number | visits per 1000 members/yr. | 12 months after patient enrollment |
|
|
|
| Secondary | 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. | Posted | Number | visits per 1000 members/yr. | 12 months after patient enrollment |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 months after patient enrollment |
|
|
|
| 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 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days prior to death for patients who died at 12-months follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | acute care visits | 30 days prior to death for patients who died at 12-months follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hospitalizations | 30 days prior to death for patients who died at 12-months follow-up |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | No | 30 days prior to death for patients who died at 12-months follow-up |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | $USD | 30 days prior to death for patients who died at 12-months follow-up |
|
|
|
| 180 |
| 425 |
| 0 |
| 425 |
| 0 |
| 425 |
| EG001 | Control Group Arm | The control group arm will receive usual care as provided by their local oncologists. Usual Care: Usual care as provided by local oncologists | 189 | 407 | 0 | 407 | 0 | 407 |
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| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Non-Hispanic Black |
|
| Asian Pacific Islander |
|
| Native Hawaiian, Alaskan Native, or American Indian |
|
| Hispanic |
|
| Non-Hispanic Black |
|
| Asian Pacific Islander |
|
| Native Hawaiian, Alaskan Native, or American Indian |
|
| Hispanic |
|
| Non-Hispanic Black |
|
| Asian Pacific Islander |
|
| Native Hawaiian, Alaskan Native, or American Indian |
|
| Hispanic |
|
| Non-Hispanic Black |
|
| Asian Pacific Islander |
|
| Native Hawaiian, Alaskan Native, or American Indian |
|
| Hispanic |
|
| Non-Hispanic Black |
|
| Asian Pacific Islander |
|
| Native Hawaiian, Alaskan Native, or American Indian |
|
| Hispanic |
|
| Non-Hispanic Black |
|
| Asian Pacific Islander |
|
| Native Hawaiian, Alaskan Native, or American Indian |
|
| Hispanic |
|
| Non-Hispanic Black |
|
| Asian Pacific Islander |
|
| Native Hawaiian, Alaskan Native, or American Indian |
|
| Hispanic |
|
| Non-Hispanic Black |
|
| Asian Pacific Islander |
|
| Native Hawaiian, Alaskan Native, or American Indian |
|
| Hispanic |
|
| Non-Hispanic Black |
|
| Asian Pacific Islander |
|
| Native Hawaiian, Alaskan Native, or American Indian |
|
| Head and neck |
|
| Malignant hematologic |
|
| Genitourinary |
|
| Other (skin, brain, bone, soft tissue, or head and neck) |
|
| Breast |
|
| Gastrointestinal |
|
| Head and neck |
|
| Malignant hematologic |
|
| Genitourinary |
|
| Other (skin, brain, bone, soft tissue, or head and neck) |
|
| Breast |
|
| Gastrointestinal |
|
| Head and neck |
|
| Malignant hematologic |
|
| Genitourinary |
|
| Other (skin, brain, bone, soft tissue, or head and neck) |
|
| Breast |
|
| Gastrointestinal |
|
| Head and neck |
|
| Malignant hematologic |
|
| Genitourinary |
|
| Other (skin, brain, bone, soft tissue, or head and neck) |
|
| Breast |
|
| Gastrointestinal |
|
| Head and neck |
|
| Malignant hematologic |
|
| Genitourinary |
|
| Other (skin, brain, bone, soft tissue, or head and neck) |
|
| Breast |
|
| Gastrointestinal |
|
| Head and neck |
|
| Malignant hematologic |
|
| Genitourinary |
|
| Other (skin, brain, bone, soft tissue, or head and neck) |
|
| Breast |
|
| Gastrointestinal |
|
| Head and neck |
|
| Malignant hematologic |
|
| Genitourinary |
|
| Other (skin, brain, bone, soft tissue, or head and neck) |
|
| Breast |
|
| Gastrointestinal |
|
| Head and neck |
|
| Malignant hematologic |
|
| Genitourinary |
|
| Other (skin, brain, bone, soft tissue, or head and neck) |
|
| Breast |
|
| Gastrointestinal |
|
| Head and neck |
|
| Malignant hematologic |
|
| Genitourinary |
|
| Other (skin, brain, bone, soft tissue, or head and neck) |
|
| Breast |
|
| III |
|
| IV |
|
| II |
|
| III |
|
| IV |
|
| II |
|
| III |
|
| IV |
|
| II |
|
| III |
|
| IV |
|
| II |
|
| III |
|
| IV |
|
| II |
|
| III |
|
| IV |
|
| II |
|
| III |
|
| IV |
|
| II |
|
| III |
|
| IV |
|
| II |
|
| III |
|
| IV |
|