Coaches Activating Reaching and Engaging Patients

Cancer Clinical Trial

— CAREPlan  

Official title:

CAREPlan: Coaches Activating, Reaching, and Engaging Patients in End-of-Life Care Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856463
• Other study ID #: Stanford12
• Status: Completed
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: September 25, 2023

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 25, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Death
• End-of-Life

Intervention

Behavioral:
• Lay Navigator Intervention
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.

Other:
• Usual Care
Usual care as provided by local oncologists

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months after patient enrollment
Secondary	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	12 months after patient enrollment
Secondary	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	12 months after patient enrollment
Secondary	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	12 months after patient enrollment
Secondary	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	12 months after patient enrollment