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Completed

NCT Number: NCT02966509

Engagement of Patients With Advanced Cancer

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.

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Key information

Conditions

End of Life Advanced Cancer Astrocytoma Cancer of Unknown Origin Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Death Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Glioblastoma Glioblastoma Multiforme Glioma Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasm Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Unknown Primary Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Rectum Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Testicular Diseases Testicular Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPAC

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • VA Palo Alto Health Care System

Registry information

Acronym: EPAC

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2016
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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