Engagement of Patients With Advanced Cancer (EPAC)

October 4, 2018 updated by: Manali Indravadan Patel, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: Intervention Arm
All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.
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.
No Intervention: B: Control Group Arm
All participants randomized to Arm B will receive usual oncologic care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 months after each patient enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency Department Visit (Chart Review)
Time Frame: 6 months after patient enrollment
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
Emergency Department Visit (Chart Review)
Time Frame: 15 months after patient enrollment
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
Hospitalization Visits (Chart Review)
Time Frame: 6 months after patient enrollment
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
Hospitalization Visits (Chart Review)
Time Frame: 15 months after patient enrollment
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
Hospice Referral (Chart Review)
Time Frame: 6 months after patient enrollment
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
Palliative Care Referral (Chart Review)
Time Frame: 6 months after patient enrollment
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
Palliative Care Referral (Chart Review)
Time Frame: 15 months after patient enrollment
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
Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
Time Frame: Change in Patient Satisfaction with Care from baseline to 6 months.
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.
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

VA Palo Alto Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPAC1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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