Engagement of Patients With Advanced Cancer

Prostate Cancer Clinical Trial

— EPAC  

Official title:

Engagement of Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966509
• Other study ID #: EPAC1
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained lay health coaches to engage patients and their families in goals of care and shared decision-making after a diagnosis of advanced cancer. Although lay health workers have never been tested in this role, we hypothesize that lay health workers can feasibly improve goals of care documentation and help to reduce unwanted healthcare utilization at the end of life for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent disease.

Description:

VAPAHCS proposes to implement and evaluate several critical elements to be in alignment with the VHA's Strategic Goal and priority areas for FY2013. The Engagement of Patients with Advanced Cancer project is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Veterans with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals with advanced cancer who have advanced cancer (stages III, IV or recurrent disease). The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved patient experiences, outcomes, and that the program helps to reduce utilization of health care resources at the end of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed stage III or IV cancer

• Recurrent disease (any stage)

• Ability to consent to study

Exclusion Criteria:

• Patients who are unable to consent to study procedures

Related Conditions & MeSH terms

• Advanced Cancer
• Cancer of Unknown Origin
• Carcinoma
• Carcinoma, Renal Cell
• Colon Cancer
• End of Life
• Gastric Cancer
• Glioblastoma
• Glioblastoma Multiforme
• Head and Neck Neoplasms
• Kidney Cancer
• Kidney Neoplasms
• Liver Cancer
• Liver Neoplasms
• Lung Neoplasm
• Lung Neoplasms
• Melanoma
• Neoplasms
• Neoplasms, Unknown Primary
• Prostate Cancer
• Rectal Neoplasms
• Rectum Cancer
• Stomach Neoplasms
• Testicular Neoplasms

Intervention

Behavioral:
• EPAC
Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	VA Palo Alto Health Care System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.	Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.	6 months after each patient enrollment
Secondary	Emergency Department Visit (Chart Review)	Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.	6 months after patient enrollment
Secondary	Emergency Department Visit (Chart Review)	Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.	15 months after patient enrollment
Secondary	Hospitalization Visits (Chart Review)	Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.	6 months after patient enrollment
Secondary	Hospitalization Visits (Chart Review)	Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.	15 months after patient enrollment
Secondary	Hospice Referral (Chart Review)	Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.	6 months after patient enrollment
Secondary	Palliative Care Referral (Chart Review)	Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.	6 months after patient enrollment
Secondary	Palliative Care Referral (Chart Review)	Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.	15 months after patient enrollment
Secondary	Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey	Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.	Change in Patient Satisfaction with Care from baseline to 6 months.
Secondary	Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey	Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.	6 months