Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

Sponsor
Stanford University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03154190
Collaborator
(none)
128
1
2
60.7
2.1

Study Details

Study Description

Brief Summary

This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Other: Laboratory Biomarker Analysis
  • Procedure: Supportive Care
  • Other: Survey Administration
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To reduce acute care utilization by 2-5% for advanced cancer patients by training and deploying health care coaches who help patients and families discuss care goals, virtual modalities, engage in shared-decision-making, and participate in educational activities.
SECONDARY OBJECTIVES:
  1. To improve patients' experience of their care. II. Improve patient understanding of advanced care planning. III. To improve the receipt of goal concordant care. IV. To reduce total healthcare costs.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive usual care.

ARM B: Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms.

After completion of study, patients are followed up for 6 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
St. Judes-Stanford Comprehensive Support Initiative
Actual Study Start Date :
Aug 8, 2017
Actual Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A (usual care)

Patients receive usual care.

Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Survey Administration
    Ancillary studies

    Experimental: Arm B (health care coach support)

    Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms.

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Procedure: Supportive Care
    Undergo health care coach support
    Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
  • Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Emergency Department Visit (Chart Review) [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. We will evaluate comparisons of emergency department visits between study arms.

    2. Hospitalization Visits (Chart Review) [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. We will evaluate comparisons of hospitalizations between the two study arms.

    Secondary Outcome Measures

    1. Change in patient satisfaction with care and decision making among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G and Patient Satisfaction with Decision Scale [Change in patient satisfaction with care and decision making from 3 months to 6, 9, and 12 months]

      Each patient will receive a satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 3 months, 6 months, 9 months, and 12 months.

    2. Change in patient satisfaction with care among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G. [Change in patient satisfaction with care from 3 months to 6, 9, and 12 months]

      Each patient will receive a satisfaction with care survey (The Consumer Assessment of Healthcare Providers and Systems-G) at 3 months, 6 months, 9 months, and 12 months.

    3. Emergency Department Visit (Chart Review) [12 months after patient enrollment]

      Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of emergency department visits between study arms.

    4. Emergency Department Visit (Chart Review) [30 days prior to death]

      Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of emergency department visits between study arms.

    5. Hospitalization Visits (Chart Review) [12 months after patient enrollment]

      Hospital use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospitalization use between study arms.

    6. Hospitalization Visits (Chart Review) [30 days prior to death]

      Hospital use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospitalization use between study arms.

    7. Hospice Consult (Chart Review) [6 months after patient enrollment]

      Hospice use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospice use between study arms.

    8. Hospice Consult (Chart Review) [12 months after patient enrollment]

      Hospice use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospice use between study arms.

    9. Hospice Consult (Chart Review) [30 days prior to death]

      Hospice use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospice use between study arms.

    10. Palliative Care Consult (Chart Review) [6 months after patient enrollment]

      Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms.

    11. Palliative Care Consult (Chart Review) [12 months after patient enrollment]

      Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms.

    12. Palliative Care Consult (Chart Review) [30 days prior to death]

      Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of palliative care use between study arms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Newly diagnosed patients for the following conditions

    • Colon cancer stage III and IV

    • Rectal cancer stage II, III, IV

    • Glioblastoma multiforme (brain) -- no stage

    • Non-small cell lung cancer stage IIIA, IIIB, IV

    • Small cell lung cancer, limited stage and extensive stage

    • Castration-resistant prostate cancer

    • Head and neck cancer stage III and IV

    • Gastric cancer stage III and IV

    • Esophageal cancer stage III and IV

    • Pancreatic cancer stage II, III, IV

    • Renal cell carcinoma, stage IV

    • Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy

    • Sarcoma, stage IV

    • Bladder carcinoma, stage IV

    • Acute myeloid leukemia

    • Melanoma, stage III and IV

    • Ovarian cancer, stage III and IV

    • High grade myelodysplastic syndrome (MDS)

    • Any patient with recurrent or progressive cancer

    • Patients must have the ability to understand and willingness to sign a written informed consent document

    • Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care

    Exclusion Criteria:
    • Patients must have capacity to consent

    • Pregnant patients are excluded

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia K Crosson Cancer Center Fullerton California United States 29835

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Manali Patel, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manali Indravadan Patel, Assistant Professor of Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03154190
    Other Study ID Numbers:
    • VAR0134
    First Posted:
    May 16, 2017
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Jan 1, 2022

    Study Results

    No Results Posted as of Feb 3, 2022