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| Name | Class |
|---|---|
| VA Palo Alto Health Care System | FED |
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The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained lay health coaches to engage patients and their families in goals of care and shared decision-making after a diagnosis of advanced cancer. Although lay health workers have never been tested in this role, we hypothesize that lay health workers can feasibly improve goals of care documentation and help to reduce unwanted healthcare utilization at the end of life for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent disease.
VAPAHCS proposes to implement and evaluate several critical elements to be in alignment with the VHA's Strategic Goal and priority areas for FY2013. The Engagement of Patients with Advanced Cancer project is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Veterans with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals with advanced cancer who have advanced cancer (stages III, IV or recurrent disease). The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved patient experiences, outcomes, and that the program helps to reduce utilization of health care resources at the end of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Intervention Arm | Experimental | All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. |
|
| B: Control Group Arm | No Intervention | All participants randomized to Arm B will receive usual oncologic care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPAC | Behavioral | Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study. | Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study. | 6 months after each patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department Visit (Chart Review) | Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. | 6 months after patient enrollment |
| Emergency Department Visit (Chart Review) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38814627 | Derived | Patel MI, Agrawal M, Blayney DW, Bundorf MK, Milstein A. Long-Term Engagement of Patients With Advanced Cancer: Results From the EPAC Randomized Clinical Trial. JAMA Oncol. 2024 Jul 1;10(7):905-911. doi: 10.1001/jamaoncol.2024.1221. | |
| 30054634 | Derived | Patel MI, Sundaram V, Desai M, Periyakoil VS, Kahn JS, Bhattacharya J, Asch SM, Milstein A, Bundorf MK. Effect of a Lay Health Worker Intervention on Goals-of-Care Documentation and on Health Care Use, Costs, and Satisfaction Among Patients With Cancer: A Randomized Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1359-1366. doi: 10.1001/jamaoncol.2018.2446. |
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August 2013 recruitment for overall study through new patient visit screening, phone calls to patients prior to first oncology appointment, and referral by physicians when diagnosed with recurrent cancers. Recruitment completed in February 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Intervention Arm | All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study. |
| FG001 | B: Control Group Arm | All participants randomized to Arm B will receive usual oncologic care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Satisfaction Survey |
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| 6 Month Satisfaction Decision Survey |
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| 6 Month Satisfaction Survey |
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| 6-Month Utilization and Cost |
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| 15-Month Utilization and Cost |
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| End of Life Utilization and Cost 6 Month |
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| End of Life Utilization and Cost 15month |
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| ID | Title | Description |
|---|---|---|
| BG000 | A: Intervention Arm | All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study. | Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study. | Posted | Count of Participants | Participants | 6 months after each patient enrollment |
|
Time frame for adverse event reporting was at 3, 6, 12, and 15 months
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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 | A: Intervention Arm | All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manali Patel | Stanford University and VA Palo Alto Health Care System | 650-723-4000 | manalip@stanford.edu |
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| ID | Term |
|---|---|
| D003643 | Death |
| D008175 | Lung Neoplasms |
| D013274 | Stomach Neoplasms |
| D003110 | Colonic Neoplasms |
| D005909 | Glioblastoma |
| D006258 | Head and Neck Neoplasms |
| D012004 | Rectal Neoplasms |
| D008545 | Melanoma |
| D007680 | Kidney Neoplasms |
| D011471 | Prostatic Neoplasms |
| D013736 | Testicular Neoplasms |
| D008113 | Liver Neoplasms |
| D009382 | Neoplasms, Unknown Primary |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| C057513 | erythromycin propionate-N-acetylcysteinate |
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Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment. |
| 15 months after patient enrollment |
| Hospitalization Visits (Chart Review) | Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. | 6 months after patient enrollment |
| Hospitalization Visits (Chart Review) | Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment. | 15 months after patient enrollment |
| Hospice Referral (Chart Review) | Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. | 6 months after patient enrollment |
| Palliative Care Referral (Chart Review) | Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. | 6 months after patient enrollment |
| Palliative Care Referral (Chart Review) | Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment. | 15 months after patient enrollment |
| 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 6 months. We will measure the change in satisfaction from baseline to 6 months. 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 6 months. | Change in Patient Satisfaction with Care from baseline to 6 months. |
| Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey | Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment. | 6 months |
| Lost to Follow-up |
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| Refused to Answer |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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|
| BG001 |
| B: Control Group Arm |
All participants randomized to Arm B will receive usual oncologic care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Country | Number | participants |
|
| Cancer Diagnosis | Count of Participants | Participants |
|
| Cancer Stage at Diagnosis | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Total Baseline Health Care Costs | Median | Inter-Quartile Range | US Dollars |
|
| OG001 |
| B: Control Group Arm |
All participants randomized to Arm B will receive usual oncologic care. |
|
|
| Secondary | Emergency Department Visit (Chart Review) | Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. | Posted | Mean | Standard Deviation | visits | 6 months after patient enrollment |
|
|
|
| Secondary | Emergency Department Visit (Chart Review) | Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment. | Posted | Mean | Standard Deviation | Visits | 15 months after patient enrollment |
|
|
|
| Secondary | Hospitalization Visits (Chart Review) | Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. | Posted | Mean | Standard Deviation | Visits | 6 months after patient enrollment |
|
|
|
| Secondary | Hospitalization Visits (Chart Review) | Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment. | Posted | Mean | Standard Deviation | Visits | 15 months after patient enrollment |
|
|
|
| Secondary | Hospice Referral (Chart Review) | Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. | Posted | Count of Participants | Participants | 6 months after patient enrollment |
|
|
|
| Secondary | Palliative Care Referral (Chart Review) | Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. | Posted | Count of Participants | Participants | 6 months after patient enrollment |
|
|
|
| Secondary | Palliative Care Referral (Chart Review) | Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment. | Posted | Count of Participants | Participants | 15 months after patient enrollment |
|
|
|
| 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 6 months. We will measure the change in satisfaction from baseline to 6 months. 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 6 months. | Posted | Mean | Standard Deviation | units on a scale | Change in Patient Satisfaction with Care from baseline to 6 months. |
|
|
|
| Secondary | Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey | Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| EG001 | B: Control Group Arm | All participants randomized to Arm B will receive usual oncologic care. | 0 | 108 | 0 | 108 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D012002 | Rectal Diseases |
| D018358 | Neuroendocrine Tumors |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D008107 | Liver Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |