Cancer
Conditions
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.
Interventions
BEHAVIORALProgram 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.
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of stage 3 and 4 cancer 2. Clinical diagnosis of hematologic malignancy 3. Must receive care at the Oncology Institute of Hope and Innovation 4. Must be an enrollee of CareMore Medicare Advantage
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edmonton Symptom Assessment Scale Score (ESAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Emergency Department Visits | 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. |
| Hospitalization Visits (Claims Review) | 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. |
| Intensive Care Unit Visits (Claims Review) | 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. |
| Total Health Care Costs (Claims Review) | 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. |
| 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. | 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. |
Participant flow
Recruitment details
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.
Pre-assignment details
Patients were excluded from the intervention and control groups if they did not require medical oncology services.
Participants by arm
| Arm | Count |
|---|---|
| Control Group All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics. | 102 |
| 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. | 186 |
| Total | 288 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 102 Participants | 186 Participants | 288 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 79 years STANDARD_DEVIATION 7.5 | 79 years STANDARD_DEVIATION 8 | 79 years STANDARD_DEVIATION 7.6 |
| Cancer Diagnosis Breast | 18 Participants | 23 Participants | 41 Participants |
| Cancer Diagnosis Genitourinary | 15 Participants | 33 Participants | 48 Participants |
| Cancer Diagnosis GI | 29 Participants | 50 Participants | 79 Participants |
| Cancer Diagnosis Malignant hematologic conditions | 14 Participants | 18 Participants | 32 Participants |
| Cancer Diagnosis Other (i.e. skin, brain, bone, soft tissues, head/neck) | 13 Participants | 33 Participants | 46 Participants |
| Cancer Diagnosis Thoracic | 13 Participants | 29 Participants | 42 Participants |
| Cancer Stage 3 | 47 Participants | 71 Participants | 118 Participants |
| Cancer Stage 4 | 55 Participants | 115 Participants | 170 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, No. (%) Asian Pacific Islander | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, No. (%) Hispanic | 42 Participants | 83 Participants | 125 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, No. (%) Native Hawaiian/Alaskan Native/American Indian | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, No. (%) Non-Hispanic Black | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, No. (%) Non-Hispanic White | 49 Participants | 88 Participants | 137 Participants |
| Sex: Female, Male Female | 57 Participants | 101 Participants | 158 Participants |
| Sex: Female, Male Male | 45 Participants | 85 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 29 / 102 | 73 / 186 |
| other Total, other adverse events | 0 / 102 | 0 / 186 |
| serious Total, serious adverse events | 0 / 102 | 0 / 186 |
Outcome results
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).
Time frame: 12 months after patient enrollment
Population: Only participants in the intervention group were invited to complete the ESAS.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Group | Edmonton Symptom Assessment Scale Score (ESAS) | Symptom score after 12 months | 7.2 score on a scale |
| Intervention Group | Edmonton Symptom Assessment Scale Score (ESAS) | Symptom score at enrollment | 9.6 score on a scale |
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.
Time frame: Change in Patient Satisfaction with Care from baseline to 5 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | Baseline (diagnosis) | 8.34 score on a scale | Standard Deviation 1.83 |
| Control Group | Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | 5-month follow-up | 8.10 score on a scale | Standard Deviation 1.96 |
| Control Group | Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | Change at 5-months | -0.23 score on a scale | Standard Deviation 1.88 |
| Intervention Group | Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | Baseline (diagnosis) | 8.10 score on a scale | Standard Deviation 1.8 |
| Intervention Group | Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | 5-month follow-up | 9.25 score on a scale | Standard Deviation 1.03 |
| Intervention Group | Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | Change at 5-months | 1.15 score on a scale | Standard Deviation 1.79 |
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.
Time frame: 12 months after patient enrollment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Hospitalization Visits (Claims Review) | No. of Admissions | 1.02 number of visits | Standard Deviation 1.44 |
| Control Group | Hospitalization Visits (Claims Review) | No. of readmissions | 0.10 number of visits | Standard Deviation 0.41 |
| Intervention Group | Hospitalization Visits (Claims Review) | No. of Admissions | 0.72 number of visits | Standard Deviation 0.96 |
| Intervention Group | Hospitalization Visits (Claims Review) | No. of readmissions | 0.18 number of visits | Standard Deviation 0.47 |
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.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Incidence of Emergency Department Visits | 0.92 visits per 1000 members/yr. |
| Intervention Group | Incidence of Emergency Department Visits | 0.61 visits per 1000 members/yr. |
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.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Intensive Care Unit Visits (Claims Review) | 0.66 number of visits | Standard Deviation 1.23 |
| Intervention Group | Intensive Care Unit Visits (Claims Review) | 0.60 number of visits | Standard Deviation 1 |
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.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Total Health Care Costs (Claims Review) | 31,946 $USD |
| Intervention Group | Total Health Care Costs (Claims Review) | 21,266 $USD |