Coaches Activating Reaching and Engaging Patients (CAREPlan)
Primary Purpose
Cancer, End-of-Life
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lay Navigator Intervention
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Cancer focused on measuring end of life, quality of care, cancer care delivery
Eligibility Criteria
Inclusion Criteria:
- All patients who receive care at Stanford Cancer Institute and have genitourinary cancers and have received greater than 2 prior courses of chemotherapy treatment
Exclusion Criteria:
- Patients without capacity to consent
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group Arm
Control Group Arm
Arm Description
Patients randomized into the intervention will be assigned a lay patient navigator who will provide information regarding early advance care planning, documentation of goals of care, and coordinating home-based care. The intervention arm will also receive usual care as provided by their local oncologists.
The control group will receive usual care as provided by their local oncologists.
Outcomes
Primary Outcome Measures
Goals of Care Documentation
Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Secondary Outcome Measures
Emergency Department Visit using chart abstraction
Emergency Department Use for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Hospitalization Visit using chart abstraction
Hospitalization Visits for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Palliative care using chart abstraction
Palliative care use for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Hospice using chart abstraction
Hospice for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03856463
Brief Title
Coaches Activating Reaching and Engaging Patients
Acronym
CAREPlan
Official Title
CAREPlan: Coaches Activating, Reaching, and Engaging Patients in End-of-Life Care Plan
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
September 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the Team Based Advance Care Planning CAREPLAN program is to understand if a trained lay navigator who engages with patients with advanced stages of cancer can help patients in advance care planning, improve patient activation, satisfaction, quality of life, and the quality of end of life cancer care while also ensuring goal concordant cancer care at the end of life.
Detailed Description
Stanford Cancer Institute plans to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their patients. The CAREPLAN (Coaches Activating, Reaching, and Engaging Patients in Their End of Life Care Plan) intervention is an innovative program aimed to strengthen provider-patient relationships and facilitate whole person care about matters important to patients diagnosed with advanced stages of cancer and important to patients' support network and family. The project is intended to help establish patients' Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for patients with cancer that is intended to improve clinical outcomes and their experiences with their cancer care. The intervention provides patients with lay navigators who assist them and their families in formulating and discussing their goals of care with their health care teams in hopes to engage in shared-decision making for goal concordant care. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation, quality of life, and quality of care and communication and that the program helps to improve goal concordant care receipt at the end of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, End-of-Life
Keywords
end of life, quality of care, cancer care delivery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
As part of usual care, patients with cancer are assigned to services by a lay navigator and this will be the control group.
For patients in the intervention, they will be assigned to the usual care lay navigator but will receive services by a lay navigator who is trained to engage patients in advance care planning.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group Arm
Arm Type
Experimental
Arm Description
Patients randomized into the intervention will be assigned a lay patient navigator who will provide information regarding early advance care planning, documentation of goals of care, and coordinating home-based care. The intervention arm will also receive usual care as provided by their local oncologists.
Arm Title
Control Group Arm
Arm Type
Active Comparator
Arm Description
The control group will receive usual care as provided by their local oncologists.
Intervention Type
Behavioral
Intervention Name(s)
Lay Navigator Intervention
Other Intervention Name(s)
Intervention Group Arm
Intervention Description
Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning and documenting goals of care.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care as provided by local oncologists
Primary Outcome Measure Information:
Title
Goals of Care Documentation
Description
Goals of Care documentation 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
Secondary Outcome Measure Information:
Title
Emergency Department Visit using chart abstraction
Description
Emergency Department Use for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Time Frame
12 months after patient enrollment
Title
Hospitalization Visit using chart abstraction
Description
Hospitalization Visits for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Time Frame
12 months after patient enrollment
Title
Palliative care using chart abstraction
Description
Palliative care use for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Time Frame
12 months after patient enrollment
Title
Hospice using chart abstraction
Description
Hospice for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment
Time Frame
12 months after patient enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who receive care at Stanford Cancer Institute and have genitourinary cancers and have received greater than 2 prior courses of chemotherapy treatment
Exclusion Criteria:
Patients without capacity to consent
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
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Coaches Activating Reaching and Engaging Patients
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