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Engagement of Patients With Advanced Cancer (EPAC)

Primary Purpose

End of Life, Advanced Cancer, Lung Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EPAC
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    A: Intervention Arm

    B: Control Group Arm

    Arm Description

    All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.

    All participants randomized to Arm B will receive usual oncologic care.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    October 10, 2016
    Last Updated
    October 4, 2018
    Sponsor
    Stanford University
    Collaborators
    VA Palo Alto Health Care System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02966509
    Brief Title
    Engagement of Patients With Advanced Cancer
    Acronym
    EPAC
    Official Title
    Engagement of Patients With Advanced Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University
    Collaborators
    VA Palo Alto Health Care System

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End of Life, Advanced Cancer, Lung Neoplasm, Gastric Cancer, Colon Cancer, Glioblastoma Multiforme, Head and Neck Neoplasms, Rectum Cancer, Melanoma, Kidney Cancer, Prostate Cancer, Testicular Neoplasms, Liver Cancer, Cancer of Unknown Origin

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    213 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A: Intervention Arm
    Arm Type
    Experimental
    Arm Description
    All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.
    Arm Title
    B: Control Group Arm
    Arm Type
    No Intervention
    Arm Description
    All participants randomized to Arm B will receive usual oncologic care.
    Intervention Type
    Behavioral
    Intervention Name(s)
    EPAC
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    6 months after each patient enrollment
    Secondary Outcome Measure Information:
    Title
    Emergency Department Visit (Chart Review)
    Description
    Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    Time Frame
    6 months after patient enrollment
    Title
    Emergency Department Visit (Chart Review)
    Description
    Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
    Time Frame
    15 months after patient enrollment
    Title
    Hospitalization Visits (Chart Review)
    Description
    Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    Time Frame
    6 months after patient enrollment
    Title
    Hospitalization Visits (Chart Review)
    Description
    Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
    Time Frame
    15 months after patient enrollment
    Title
    Hospice Referral (Chart Review)
    Description
    Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    Time Frame
    6 months after patient enrollment
    Title
    Palliative Care Referral (Chart Review)
    Description
    Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    Time Frame
    6 months after patient enrollment
    Title
    Palliative Care Referral (Chart Review)
    Description
    Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
    Time Frame
    15 months after patient enrollment
    Title
    Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
    Description
    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.
    Time Frame
    Change in Patient Satisfaction with Care from baseline to 6 months.
    Title
    Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30054634
    Citation
    Patel MI, Sundaram V, Desai M, Periyakoil VS, Kahn JS, Bhattacharya J, Asch SM, Milstein A, Bundorf MK. Effect of a Lay Health Worker Intervention on Goals-of-Care Documentation and on Health Care Use, Costs, and Satisfaction Among Patients With Cancer: A Randomized Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1359-1366. doi: 10.1001/jamaoncol.2018.2446.
    Results Reference
    derived

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    Engagement of Patients With Advanced Cancer

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