Coaches Activating Reaching and Engaging Patients

Overview

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.

Full Title of Study: “CAREPlan: Coaches Activating, Reaching, and Engaging Patients in End-of-Life Care Plan”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 3, 2023

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Control Group Arm
    • The control group will receive usual care as provided by their local oncologists.

Clinical Trial Outcome Measures

Primary Measures

  • Goals of Care Documentation
    • Time Frame: 12 months after patient enrollment
    • 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 Measures

  • Emergency Department Visit using chart abstraction
    • Time Frame: 12 months after patient enrollment
    • 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
    • Time Frame: 12 months after patient enrollment
    • 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
    • Time Frame: 12 months after patient enrollment
    • 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
    • Time Frame: 12 months after patient enrollment
    • Hospice for each patient will be assessed by electronic health record abstraction from time of enrollment to 12 months after patient enrollment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Manali Indravadan Patel, Assistant Professor – Stanford University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.