Cancer, End of Life
Conditions
Keywords
cancer end of life patient-centered
Brief summary
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.
Detailed description
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.
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.
OTHERUsual Care
Usual care as provided by local oncologists
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed with cancer * Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician. * Must be 18 years or older. * Must have capacity to verbally consent
Exclusion criteria
-Inability to consent to the study due to lack of capacity as documented by the referring physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edmonton Symptom Assessment Scale (ESAS) Symptom Screen | Baseline (at time of patient enrollment) | 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). |
| Personal Health Questionnaire-9 (PHQ-9) Depression Screen | Baseline (at time of patient enrollment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Hospice Consult Within 12-months After Patient Enrollment (Chart Review) | 12 months after patient enrollment | Hospice consult for each patient will be abstracted by electronic medical record chart 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. |
| Number of Patients With an Acute Care Facility Death (Chart Review) | 30 days prior to death for patients who died at 12-months follow-up | 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. |
| Incidence of Emergency Department Visits Within 12-months After Patient Enrollment (Chart Review) | 12 months after patient enrollment | 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. |
| Number of Hospitalization Visits in the Last 30 Days of Life (Chart Review) | 30 days prior to death for patients who died at 12-months follow-up | 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. |
| Number of Patients With a Hospice Consult in the Last 30 Days of Life (Chart Review) | 30 days prior to death for patients who died at 12-months follow-up | 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. |
| Total Costs of Care (Claims Review) | 30 days prior to death for patients who died at 12-months follow-up | 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. |
| Number of Emergency Department Visit in the Last 30 Days of Life (Chart Review) | 30 days prior to death for patients who died at 12-months follow-up | 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. |
| Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review) | 12 months after patient enrollment | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 425 |
| 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 | 407 |
| Total | 832 |
Baseline characteristics
| Characteristic | Intervention Group Arm | Total | Control Group Arm |
|---|---|---|---|
| Age, Customized Clinic A | 79.6 years STANDARD_DEVIATION 10.2 | 79.2 years STANDARD_DEVIATION 10.2 | 78.6 years STANDARD_DEVIATION 10.3 |
| Age, Customized Clinic B | 79.5 years STANDARD_DEVIATION 9.8 | 79.4 years STANDARD_DEVIATION 9.3 | 79.3 years STANDARD_DEVIATION 9.1 |
| Age, Customized Clinic C | 78.1 years STANDARD_DEVIATION 10.2 | 79.2 years STANDARD_DEVIATION 10.8 | 80.0 years STANDARD_DEVIATION 10.6 |
| Age, Customized Clinic D | 77.1 years STANDARD_DEVIATION 10.2 | 78 years STANDARD_DEVIATION 10.9 | 80.0 years STANDARD_DEVIATION 11.2 |
| Age, Customized Clinic E | 78.9 years STANDARD_DEVIATION 10.4 | 79 years STANDARD_DEVIATION 10.3 | 80.7 years STANDARD_DEVIATION 10.2 |
| Age, Customized Clinic F | 80.0 years STANDARD_DEVIATION 10.2 | 79.8 years STANDARD_DEVIATION 10.2 | 79.4 years STANDARD_DEVIATION 10.3 |
| Age, Customized Clinic G | 77.5 years STANDARD_DEVIATION 10.4 | 77.6 years STANDARD_DEVIATION 10.2 | 77.7 years STANDARD_DEVIATION 10.2 |
| Age, Customized Clinic H | 76.4 years STANDARD_DEVIATION 10.1 | 76.8 years STANDARD_DEVIATION 10.1 | 77.9 years STANDARD_DEVIATION 10.2 |
| Age, Customized Clinic I | 77.2 years STANDARD_DEVIATION 10.2 | 78 years STANDARD_DEVIATION 10.2 | 78.9 years STANDARD_DEVIATION 10.1 |
| Cancer diagnosis Clinic A Breast | 19 Participants | 43 Participants | 24 Participants |
| Cancer diagnosis Clinic A Gastrointestinal | 19 Participants | 38 Participants | 19 Participants |
| Cancer diagnosis Clinic A Genitourinary | 17 Participants | 25 Participants | 8 Participants |
| Cancer diagnosis Clinic A Head and neck | 4 Participants | 7 Participants | 3 Participants |
| Cancer diagnosis Clinic A Malignant hematologic | 4 Participants | 10 Participants | 6 Participants |
| Cancer diagnosis Clinic A Other (skin, brain, bone, soft tissue, or head and neck) | 9 Participants | 18 Participants | 9 Participants |
| Cancer diagnosis Clinic A Thoracic | 8 Participants | 14 Participants | 6 Participants |
| Cancer diagnosis Clinic B Breast | 10 Participants | 19 Participants | 9 Participants |
| Cancer diagnosis Clinic B Gastrointestinal | 10 Participants | 22 Participants | 12 Participants |
| Cancer diagnosis Clinic B Genitourinary | 4 Participants | 8 Participants | 4 Participants |
| Cancer diagnosis Clinic B Head and neck | 3 Participants | 5 Participants | 2 Participants |
| Cancer diagnosis Clinic B Malignant hematologic | 7 Participants | 13 Participants | 6 Participants |
| Cancer diagnosis Clinic B Other (skin, brain, bone, soft tissue, or head and neck) | 6 Participants | 13 Participants | 7 Participants |
| Cancer diagnosis Clinic B Thoracic | 7 Participants | 12 Participants | 5 Participants |
| Cancer diagnosis Clinic C Breast | 15 Participants | 29 Participants | 14 Participants |
| Cancer diagnosis Clinic C Gastrointestinal | 7 Participants | 16 Participants | 9 Participants |
| Cancer diagnosis Clinic C Genitourinary | 5 Participants | 9 Participants | 4 Participants |
| Cancer diagnosis Clinic C Head and neck | 1 Participants | 1 Participants | 0 Participants |
| Cancer diagnosis Clinic C Malignant hematologic | 4 Participants | 11 Participants | 7 Participants |
| Cancer diagnosis Clinic C Other (skin, brain, bone, soft tissue, or head and neck) | 8 Participants | 12 Participants | 4 Participants |
| Cancer diagnosis Clinic C Thoracic | 4 Participants | 8 Participants | 4 Participants |
| Cancer diagnosis Clinic D Breast | 13 Participants | 22 Participants | 9 Participants |
| Cancer diagnosis Clinic D Gastrointestinal | 10 Participants | 21 Participants | 11 Participants |
| Cancer diagnosis Clinic D Genitourinary | 3 Participants | 11 Participants | 8 Participants |
| Cancer diagnosis Clinic D Head and neck | 0 Participants | 1 Participants | 1 Participants |
| Cancer diagnosis Clinic D Malignant hematologic | 1 Participants | 5 Participants | 4 Participants |
| Cancer diagnosis Clinic D Other (skin, brain, bone, soft tissue, or head and neck) | 7 Participants | 9 Participants | 2 Participants |
| Cancer diagnosis Clinic D Thoracic | 5 Participants | 9 Participants | 4 Participants |
| Cancer diagnosis Clinic E Breast | 6 Participants | 20 Participants | 14 Participants |
| Cancer diagnosis Clinic E Gastrointestinal | 15 Participants | 25 Participants | 10 Participants |
| Cancer diagnosis Clinic E Genitourinary | 9 Participants | 13 Participants | 4 Participants |
| Cancer diagnosis Clinic E Head and neck | 1 Participants | 3 Participants | 2 Participants |
| Cancer diagnosis Clinic E Malignant hematologic | 5 Participants | 11 Participants | 6 Participants |
| Cancer diagnosis Clinic E Other (skin, brain, bone, soft tissue, or head and neck) | 8 Participants | 11 Participants | 3 Participants |
| Cancer diagnosis Clinic E Thoracic | 1 Participants | 6 Participants | 5 Participants |
| Cancer diagnosis Clinic F Breast | 10 Participants | 22 Participants | 12 Participants |
| Cancer diagnosis Clinic F Gastrointestinal | 10 Participants | 23 Participants | 13 Participants |
| Cancer diagnosis Clinic F Genitourinary | 4 Participants | 9 Participants | 5 Participants |
| Cancer diagnosis Clinic F Head and neck | 2 Participants | 3 Participants | 1 Participants |
| Cancer diagnosis Clinic F Malignant hematologic | 4 Participants | 7 Participants | 3 Participants |
| Cancer diagnosis Clinic F Other (skin, brain, bone, soft tissue, or head and neck) | 5 Participants | 8 Participants | 3 Participants |
| Cancer diagnosis Clinic F Thoracic | 7 Participants | 10 Participants | 3 Participants |
| Cancer diagnosis Clinic G Breast | 8 Participants | 16 Participants | 8 Participants |
| Cancer diagnosis Clinic G Gastrointestinal | 16 Participants | 29 Participants | 13 Participants |
| Cancer diagnosis Clinic G Genitourinary | 6 Participants | 13 Participants | 7 Participants |
| Cancer diagnosis Clinic G Head and neck | 0 Participants | 0 Participants | 0 Participants |
| Cancer diagnosis Clinic G Malignant hematologic | 4 Participants | 9 Participants | 5 Participants |
| Cancer diagnosis Clinic G Other (skin, brain, bone, soft tissue, or head and neck) | 3 Participants | 5 Participants | 2 Participants |
| Cancer diagnosis Clinic G Thoracic | 3 Participants | 6 Participants | 3 Participants |
| Cancer diagnosis Clinic H Breast | 8 Participants | 23 Participants | 15 Participants |
| Cancer diagnosis Clinic H Gastrointestinal | 20 Participants | 36 Participants | 16 Participants |
| Cancer diagnosis Clinic H Genitourinary | 3 Participants | 4 Participants | 1 Participants |
| Cancer diagnosis Clinic H Head and neck | 3 Participants | 3 Participants | 0 Participants |
| Cancer diagnosis Clinic H Malignant hematologic | 8 Participants | 12 Participants | 4 Participants |
| Cancer diagnosis Clinic H Other (skin, brain, bone, soft tissue, or head and neck) | 2 Participants | 6 Participants | 4 Participants |
| Cancer diagnosis Clinic H Thoracic | 3 Participants | 6 Participants | 3 Participants |
| Cancer diagnosis Clinic I Breast | 5 Participants | 17 Participants | 12 Participants |
| Cancer diagnosis Clinic I Gastrointestinal | 10 Participants | 23 Participants | 13 Participants |
| Cancer diagnosis Clinic I Genitourinary | 6 Participants | 7 Participants | 1 Participants |
| Cancer diagnosis Clinic I Head and neck | 3 Participants | 4 Participants | 1 Participants |
| Cancer diagnosis Clinic I Malignant hematologic | 5 Participants | 9 Participants | 4 Participants |
| Cancer diagnosis Clinic I Other (skin, brain, bone, soft tissue, or head and neck) | 7 Participants | 11 Participants | 4 Participants |
| Cancer diagnosis Clinic I Thoracic | 5 Participants | 11 Participants | 6 Participants |
| Cancer Stage Clinic A I | 14 Participants | 27 Participants | 13 Participants |
| Cancer Stage Clinic A II | 16 Participants | 32 Participants | 16 Participants |
| Cancer Stage Clinic A III | 18 Participants | 30 Participants | 12 Participants |
| Cancer Stage Clinic A IV | 32 Participants | 66 Participants | 34 Participants |
| Cancer Stage Clinic B I | 11 Participants | 25 Participants | 14 Participants |
| Cancer Stage Clinic B II | 9 Participants | 14 Participants | 5 Participants |
| Cancer Stage Clinic B III | 9 Participants | 13 Participants | 4 Participants |
| Cancer Stage Clinic B IV | 18 Participants | 40 Participants | 22 Participants |
| Cancer Stage Clinic C I | 13 Participants | 26 Participants | 13 Participants |
| Cancer Stage Clinic C II | 11 Participants | 17 Participants | 6 Participants |
| Cancer Stage Clinic C III | 6 Participants | 13 Participants | 7 Participants |
| Cancer Stage Clinic C IV | 14 Participants | 30 Participants | 16 Participants |
| Cancer Stage Clinic D I | 7 Participants | 12 Participants | 5 Participants |
| Cancer Stage Clinic D II | 6 Participants | 14 Participants | 8 Participants |
| Cancer Stage Clinic D III | 11 Participants | 22 Participants | 11 Participants |
| Cancer Stage Clinic D IV | 15 Participants | 30 Participants | 15 Participants |
| Cancer Stage Clinic E I | 9 Participants | 18 Participants | 9 Participants |
| Cancer Stage Clinic E II | 8 Participants | 16 Participants | 8 Participants |
| Cancer Stage Clinic E III | 10 Participants | 18 Participants | 8 Participants |
| Cancer Stage Clinic E IV | 22 Participants | 41 Participants | 19 Participants |
| Cancer Stage Clinic F I | 11 Participants | 23 Participants | 12 Participants |
| Cancer Stage Clinic F II | 7 Participants | 14 Participants | 7 Participants |
| Cancer Stage Clinic F III | 5 Participants | 11 Participants | 6 Participants |
| Cancer Stage Clinic F IV | 19 Participants | 34 Participants | 15 Participants |
| Cancer Stage Clinic G I | 10 Participants | 15 Participants | 5 Participants |
| Cancer Stage Clinic G II | 5 Participants | 10 Participants | 5 Participants |
| Cancer Stage Clinic G III | 9 Participants | 16 Participants | 7 Participants |
| Cancer Stage Clinic G IV | 16 Participants | 37 Participants | 21 Participants |
| Cancer Stage Clinic H I | 12 Participants | 23 Participants | 11 Participants |
| Cancer Stage Clinic H II | 10 Participants | 19 Participants | 9 Participants |
| Cancer Stage Clinic H III | 7 Participants | 13 Participants | 6 Participants |
| Cancer Stage Clinic H IV | 18 Participants | 35 Participants | 17 Participants |
| Cancer Stage Clinic I I | 5 Participants | 14 Participants | 9 Participants |
| Cancer Stage Clinic I II | 11 Participants | 16 Participants | 5 Participants |
| Cancer Stage Clinic I III | 6 Participants | 14 Participants | 8 Participants |
| Cancer Stage Clinic I IV | 19 Participants | 38 Participants | 19 Participants |
| Race/Ethnicity, Customized Clinic A Asian Pacific Islander | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Clinic A Hispanic | 37 Participants | 65 Participants | 28 Participants |
| Race/Ethnicity, Customized Clinic A Native Hawaiian, Alaskan Native, or American Indian | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic A Non-Hispanic Black | 3 Participants | 9 Participants | 6 Participants |
| Race/Ethnicity, Customized Clinic A Non-Hispanic White | 38 Participants | 74 Participants | 36 Participants |
| Race/Ethnicity, Customized Clinic B Asian Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Clinic B Hispanic | 18 Participants | 39 Participants | 21 Participants |
| Race/Ethnicity, Customized Clinic B Native Hawaiian, Alaskan Native, or American Indian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic B Non-Hispanic Black | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Clinic B Non-Hispanic White | 25 Participants | 43 Participants | 18 Participants |
| Race/Ethnicity, Customized Clinic C Asian Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic C Hispanic | 17 Participants | 34 Participants | 17 Participants |
| Race/Ethnicity, Customized Clinic C Native Hawaiian, Alaskan Native, or American Indian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Clinic C Non-Hispanic Black | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Clinic C Non-Hispanic White | 25 Participants | 47 Participants | 22 Participants |
| Race/Ethnicity, Customized Clinic D Asian Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic D Hispanic | 20 Participants | 35 Participants | 15 Participants |
| Race/Ethnicity, Customized Clinic D Native Hawaiian, Alaskan Native, or American Indian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Clinic D Non-Hispanic Black | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Clinic D Non-Hispanic White | 16 Participants | 36 Participants | 20 Participants |
| Race/Ethnicity, Customized Clinic E Asian Pacific Islander | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Clinic E Hispanic | 19 Participants | 43 Participants | 24 Participants |
| Race/Ethnicity, Customized Clinic E Native Hawaiian, Alaskan Native, or American Indian | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized Clinic E Non-Hispanic Black | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic E Non-Hispanic White | 18 Participants | 33 Participants | 15 Participants |
| Race/Ethnicity, Customized Clinic F Asian Pacific Islander | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Clinic F Hispanic | 21 Participants | 32 Participants | 11 Participants |
| Race/Ethnicity, Customized Clinic F Native Hawaiian, Alaskan Native, or American Indian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic F Non-Hispanic Black | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Clinic F Non-Hispanic White | 20 Participants | 43 Participants | 23 Participants |
| Race/Ethnicity, Customized Clinic G Asian Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic G Hispanic | 19 Participants | 31 Participants | 12 Participants |
| Race/Ethnicity, Customized Clinic G Native Hawaiian, Alaskan Native, or American Indian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic G Non-Hispanic Black | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Clinic G Non-Hispanic White | 21 Participants | 43 Participants | 22 Participants |
| Race/Ethnicity, Customized Clinic H Asian Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic H Hispanic | 21 Participants | 38 Participants | 17 Participants |
| Race/Ethnicity, Customized Clinic H Native Hawaiian, Alaskan Native, or American Indian | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic H Non-Hispanic Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Clinic H Non-Hispanic White | 22 Participants | 43 Participants | 21 Participants |
| Race/Ethnicity, Customized Clinic I Asian Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Clinic I Hispanic | 14 Participants | 30 Participants | 16 Participants |
| Race/Ethnicity, Customized Clinic I Native Hawaiian, Alaskan Native, or American Indian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Clinic I Non-Hispanic Black | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Clinic I Non-Hispanic White | 23 Participants | 45 Participants | 22 Participants |
| Risk Adjustment Factor Clinic A | 2.96 Risk Adjustment Factor Score STANDARD_DEVIATION 1.86 | 2.88 Risk Adjustment Factor Score STANDARD_DEVIATION 1.86 | 2.69 Risk Adjustment Factor Score STANDARD_DEVIATION 1.86 |
| Risk Adjustment Factor Clinic B | 2.54 Risk Adjustment Factor Score STANDARD_DEVIATION 1.37 | 2.76 Risk Adjustment Factor Score STANDARD_DEVIATION 1.88 | 2.89 Risk Adjustment Factor Score STANDARD_DEVIATION 2.08 |
| Risk Adjustment Factor Clinic C | 2.23 Risk Adjustment Factor Score STANDARD_DEVIATION 1.65 | 2.43 Risk Adjustment Factor Score STANDARD_DEVIATION 1.66 | 2.67 Risk Adjustment Factor Score STANDARD_DEVIATION 1.7 |
| Risk Adjustment Factor Clinic D | 2.42 Risk Adjustment Factor Score STANDARD_DEVIATION 1.69 | 2.52 Risk Adjustment Factor Score STANDARD_DEVIATION 1.71 | 2.69 Risk Adjustment Factor Score STANDARD_DEVIATION 1.74 |
| Risk Adjustment Factor Clinic E | 2.59 Risk Adjustment Factor Score STANDARD_DEVIATION 1.75 | 2.56 Risk Adjustment Factor Score STANDARD_DEVIATION 1.88 | 2.55 Risk Adjustment Factor Score STANDARD_DEVIATION 1.99 |
| Risk Adjustment Factor Clinic F | 2.22 Risk Adjustment Factor Score STANDARD_DEVIATION 1.82 | 2.44 Risk Adjustment Factor Score STANDARD_DEVIATION 1.72 | 2.76 Risk Adjustment Factor Score STANDARD_DEVIATION 1.66 |
| Risk Adjustment Factor Clinic G | 2.84 Risk Adjustment Factor Score STANDARD_DEVIATION 2.07 | 2.67 Risk Adjustment Factor Score STANDARD_DEVIATION 1.89 | 2.56 Risk Adjustment Factor Score STANDARD_DEVIATION 1.73 |
| Risk Adjustment Factor Clinic H | 2.73 Risk Adjustment Factor Score STANDARD_DEVIATION 2.12 | 2.52 Risk Adjustment Factor Score STANDARD_DEVIATION 1.82 | 2.46 Risk Adjustment Factor Score STANDARD_DEVIATION 1.22 |
| Risk Adjustment Factor Clinic I | 2.93 Risk Adjustment Factor Score STANDARD_DEVIATION 1.79 | 2.87 Risk Adjustment Factor Score STANDARD_DEVIATION 2.11 | 2.83 Risk Adjustment Factor Score STANDARD_DEVIATION 2.23 |
| Sex: Female, Male Clinic A Female | 38 Participants | 63 Participants | 25 Participants |
| Sex: Female, Male Clinic A Male | 42 Participants | 92 Participants | 50 Participants |
| Sex: Female, Male Clinic B Female | 23 Participants | 40 Participants | 17 Participants |
| Sex: Female, Male Clinic B Male | 24 Participants | 52 Participants | 28 Participants |
| Sex: Female, Male Clinic C Female | 20 Participants | 32 Participants | 12 Participants |
| Sex: Female, Male Clinic C Male | 24 Participants | 54 Participants | 30 Participants |
| Sex: Female, Male Clinic D Female | 12 Participants | 30 Participants | 18 Participants |
| Sex: Female, Male Clinic D Male | 27 Participants | 48 Participants | 21 Participants |
| Sex: Female, Male Clinic E Female | 20 Participants | 36 Participants | 16 Participants |
| Sex: Female, Male Clinic E Male | 25 Participants | 53 Participants | 28 Participants |
| Sex: Female, Male Clinic F Female | 20 Participants | 39 Participants | 19 Participants |
| Sex: Female, Male Clinic F Male | 22 Participants | 43 Participants | 21 Participants |
| Sex: Female, Male Clinic G Female | 15 Participants | 36 Participants | 21 Participants |
| Sex: Female, Male Clinic G Male | 25 Participants | 42 Participants | 17 Participants |
| Sex: Female, Male Clinic H Female | 23 Participants | 36 Participants | 13 Participants |
| Sex: Female, Male Clinic H Male | 24 Participants | 54 Participants | 30 Participants |
| Sex: Female, Male Clinic I Female | 20 Participants | 33 Participants | 13 Participants |
| Sex: Female, Male Clinic I Male | 21 Participants | 49 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 180 / 425 | 189 / 407 |
| other Total, other adverse events | 0 / 425 | 0 / 407 |
| serious Total, serious adverse events | 0 / 425 | 0 / 407 |
Outcome results
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).
Time frame: Baseline (at time of patient enrollment)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group Arm | Edmonton Symptom Assessment Scale (ESAS) Symptom Screen | 7 total score on a scale |
| Control Group Arm | Edmonton Symptom Assessment Scale (ESAS) Symptom Screen | 7 total score on a scale |
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).
Time frame: 6 months after patient enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group Arm | Edmonton Symptom Assessment Scale (ESAS) Symptom Screen | 8.2 score on a scale |
| Control Group Arm | Edmonton Symptom Assessment Scale (ESAS) Symptom Screen | 9.8 score on a scale |
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).
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group Arm | Edmonton Symptom Assessment Scale (ESAS) Symptom Screen | 7 score on a scale |
| Control Group Arm | Edmonton Symptom Assessment Scale (ESAS) Symptom Screen | 9.8 score on a scale |
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.
Time frame: Baseline (at time of patient enrollment)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group Arm | Personal Health Questionnaire-9 (PHQ-9) Depression Screen | 2.9 units on a scale |
| Control Group Arm | Personal Health Questionnaire-9 (PHQ-9) Depression Screen | 2.7 units on a scale |
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.
Time frame: 6 months after patient enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group Arm | Personal Health Questionnaire-9 (PHQ-9) Depression Screen | 2.5 score on a scale |
| Control Group Arm | Personal Health Questionnaire-9 (PHQ-9) Depression Screen | 2.9 score on a scale |
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.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group Arm | Personal Health Questionnaire-9 (PHQ-9) Depression Screen | 1.9 score on a scale |
| Control Group Arm | Personal Health Questionnaire-9 (PHQ-9) Depression Screen | 3.9 score on a scale |
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.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group Arm | Incidence of Emergency Department Visits Within 12-months After Patient Enrollment (Chart Review) | 0.43 visits per 1000 members/yr. |
| Control Group Arm | Incidence of Emergency Department Visits Within 12-months After Patient Enrollment (Chart Review) | 0.57 visits per 1000 members/yr. |
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.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group Arm | Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review) | 0.54 visits per 1000 members/yr. |
| Control Group Arm | Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review) | 0.72 visits per 1000 members/yr. |
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.
Time frame: 30 days prior to death for patients who died at 12-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group Arm | Number of Emergency Department Visit in the Last 30 Days of Life (Chart Review) | 0.10 acute care visits | Standard Deviation 0.3 |
| Control Group Arm | Number of Emergency Department Visit in the Last 30 Days of Life (Chart Review) | 0.30 acute care visits | Standard Deviation 0.46 |
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.
Time frame: 30 days prior to death for patients who died at 12-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group Arm | Number of Hospitalization Visits in the Last 30 Days of Life (Chart Review) | 0.27 hospitalizations | Standard Deviation 0.44 |
| Control Group Arm | Number of Hospitalization Visits in the Last 30 Days of Life (Chart Review) | 0.43 hospitalizations | Standard Deviation 0.82 |
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.
Time frame: 30 days prior to death for patients who died at 12-months follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group Arm | Number of Patients With a Hospice Consult in the Last 30 Days of Life (Chart Review) | 125 Participants |
| Control Group Arm | Number of Patients With a Hospice Consult in the Last 30 Days of Life (Chart Review) | 79 Participants |
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.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group Arm | Number of Patients With a Hospice Consult Within 12-months After Patient Enrollment (Chart Review) | 207 Participants |
| Control Group Arm | Number of Patients With a Hospice Consult Within 12-months After Patient Enrollment (Chart Review) | 101 Participants |
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.
Time frame: 30 days prior to death for patients who died at 12-months follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group Arm | Number of Patients With an Acute Care Facility Death (Chart Review) | 18 Participants |
| Control Group Arm | Number of Patients With an Acute Care Facility Death (Chart Review) | 30 Participants |
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.
Time frame: 30 days prior to death for patients who died at 12-months follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group Arm | Total Costs of Care (Claims Review) | 3,602 $USD |
| Control Group Arm | Total Costs of Care (Claims Review) | 12,726 $USD |
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) |
|---|---|---|
| Intervention Group Arm | Total Health Care Costs (Claims Review) | 17,869 $USD |
| Control Group Arm | Total Health Care Costs (Claims Review) | 18,473 $USD |