Enhancing Community Capacity to Improve Cancer Care Delivery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: 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.
Other: Usual Care
Usual care as provided by local oncologists
|
| Active Comparator: Control Group Arm The control group arm will receive usual care as provided by their local oncologists. |
Other: Usual Care
Usual care as provided by local oncologists
|
Outcome Measures
Primary Outcome Measures
- 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). The scale is a 10-point scale measured from 0 to 10 where 0 represents no symptom and 10 represents the worse severity of the symptom. The scale measures 10 symptoms.
- Edmonton Symptom Assessment Scale (ESAS) Symptom Screen [6 months after patient enrollment]
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale) at 6 months. The scale is a 10-point scale measured from 0 to 10 where 0 represents no symptom and 10 represents the worse severity of the symptom. The scale measures 10 symptoms.
- Edmonton Symptom Assessment Scale (ESAS) Symptom Screen [12 months after patient enrollment]
Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale) at 12 months. The scale is a 10-point scale measured from 0 to 10 where 0 represents no symptom and 10 represents the worse severity of the symptom. The scale measures 10 symptoms.
- 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.
- Personal Health Questionnaire-9 (PHQ-9) Depression Screen [6 months after patient enrollment]
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.
- Personal Health Questionnaire-9 (PHQ-9) Depression Screen [12 months after patient enrollment]
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.
Secondary Outcome Measures
- % of patients with Emergency Department Visit 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 % of patients with emergency department visits between study arms.
- % of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review) [12 months after patient enrollment]
Hospitalization 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 hospitalizations between the two study arms.
- % 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.
- % 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.
- % of patients with 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 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.
- % of patients with 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.
- % 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Newly diagnosed with cancer
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Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oncology Institute for Hope and Innovation | Los Angeles | California | United States |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Manali I Patel, MD MPH MS, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 455