Coaches Activating Reaching and Engaging Patients

NCT03856463 | Completed

• 1 other identifier: Stanford12
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; End-of-Life

Keywords

end of life; quality of care; cancer care delivery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Emergency Department Visit using chart abstraction

  12 months after patient enrollment

• Hospitalization Visit using chart abstraction

  12 months after patient enrollment

• Palliative care using chart abstraction

  12 months after patient enrollment

• Hospice using chart abstraction

  12 months after patient enrollment

Study Arms (2)

Intervention Group Arm

EXPERIMENTAL

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; Other: Usual Care

Control Group Arm

ACTIVE COMPARATOR

The control group will receive usual care as provided by their local oncologists.

Other: Usual Care

Interventions

Lay Navigator Intervention BEHAVIORAL

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.

Also known as: Intervention Group Arm

Intervention Group Arm

Usual Care OTHER

Usual care as provided by local oncologists

Control Group Arm; Intervention Group Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who receive care at Stanford Cancer Institute and have genitourinary cancers and have received greater than 2 prior courses of chemotherapy treatment

You may not qualify if:

• Patients without capacity to consent

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Rodriguez GM, Parikh DA, Kapphahn K, Gupta DM, Fan AC, Shah S, Srinivas S, Teuteberg W, Seevaratnam B, Asuncion K, Chien J, Moore K, Ruiz SM, Patel MI. Coaches Activating, Reaching, and Engaging Patients to Engage in Advance Care Planning: A Randomized Clinical Trial. JAMA Oncol. 2024 Jul 1;10(7):949-953. doi: 10.1001/jamaoncol.2024.1242.

  PMID: 38780960 DERIVED

MeSH Terms

Conditions

Neoplasms; Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 27, 2019
• Study Start: April 3, 2019
• Primary Completion: April 3, 2023
• Study Completion: September 25, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

US (1)