Engagement of Patients With Advanced Cancer (EPAC)
Primary Purpose
End of Life, Advanced Cancer, Lung Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EPAC
Sponsored by
About this trial
This is an interventional health services research trial for End of Life
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed stage III or IV cancer
- Recurrent disease (any stage)
- Ability to consent to study
Exclusion Criteria:
- Patients who are unable to consent to study procedures
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A: Intervention Arm
B: Control Group Arm
Arm Description
All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.
All participants randomized to Arm B will receive usual oncologic care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02966509
First Posted
October 10, 2016
Last Updated
October 4, 2018
Sponsor
Stanford University
Collaborators
VA Palo Alto Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT02966509
Brief Title
Engagement of Patients With Advanced Cancer
Acronym
EPAC
Official Title
Engagement of Patients With Advanced Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
VA Palo Alto Health Care System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End of Life, Advanced Cancer, Lung Neoplasm, Gastric Cancer, Colon Cancer, Glioblastoma Multiforme, Head and Neck Neoplasms, Rectum Cancer, Melanoma, Kidney Cancer, Prostate Cancer, Testicular Neoplasms, Liver Cancer, Cancer of Unknown Origin
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: Intervention Arm
Arm Type
Experimental
Arm Description
All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.
Arm Title
B: Control Group Arm
Arm Type
No Intervention
Arm Description
All participants randomized to Arm B will receive usual oncologic care.
Intervention Type
Behavioral
Intervention Name(s)
EPAC
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months after each patient enrollment
Secondary Outcome Measure Information:
Title
Emergency Department Visit (Chart Review)
Description
Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
Time Frame
6 months after patient enrollment
Title
Emergency Department Visit (Chart Review)
Description
Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
Time Frame
15 months after patient enrollment
Title
Hospitalization Visits (Chart Review)
Description
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
Time Frame
6 months after patient enrollment
Title
Hospitalization Visits (Chart Review)
Description
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
Time Frame
15 months after patient enrollment
Title
Hospice Referral (Chart Review)
Description
Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
Time Frame
6 months after patient enrollment
Title
Palliative Care Referral (Chart Review)
Description
Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
Time Frame
6 months after patient enrollment
Title
Palliative Care Referral (Chart Review)
Description
Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
Time Frame
15 months after patient enrollment
Title
Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
Description
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.
Time Frame
Change in Patient Satisfaction with Care from baseline to 6 months.
Title
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed stage III or IV cancer
Recurrent disease (any stage)
Ability to consent to study
Exclusion Criteria:
Patients who are unable to consent to study procedures
12. IPD Sharing Statement
Citations:
PubMed Identifier
30054634
Citation
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.
Results Reference
derived
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Engagement of Patients With Advanced Cancer
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