Enhancing Community Capacity to Improve Cancer Care Delivery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Enhancing Community Capacity to Improve Cancer Care Delivery: The Effect of a Lay Health Worker Intervention on Patient-reported Symptoms, Healthcare Use, Total Costs of Care, and End-of-life Care Delivery

Conditions
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End of Life, Cancer

Intervention / Treatment
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* Behavioral: Program participants
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group Arm<br>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<br>* 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.<br>Other: Usual Care<br>* Usual care as provided by local oncologists<br>|
| Active Comparator: Control Group Arm<br>The control group arm will receive usual care as provided by their local oncologists. | Other: Usual Care<br>* Usual care as provided by local oncologists<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edmonton Symptom Assessment Scale (ESAS) Symptom Screen | 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. | 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) 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. | 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) 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. | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with Emergency Department Visit 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 % of patients with emergency department visits between study arms. | 12 months after patient enrollment | 
| % of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review) | 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. | 12 months after patient enrollment | 
| % 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 | 
| % 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 | 
| % of patients with Emergency Department Visit in the last 30 days of life (Chart Review) | 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. | 30 days prior to death for patients who died at 12-months follow-up | 
| % of patients with 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 | 
| % 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer end of life patient-centered