Coaches Activating Reaching and Engaging Patients (CAREPlan)

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; End-of-Life
• Intervention / Treatment: Behavioral: Lay Navigator Intervention; Other: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group Arm; 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.	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 Names: Intervention Group Arm; Other: Usual Care; Usual care as provided by local oncologists
Active Comparator: Control Group Arm; The control group will receive usual care as provided by their local oncologists.	Other: Usual Care; Usual care as provided by local oncologists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Actual): April 3, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: quality of care; end of life; cancer care delivery
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: Stanford12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No