<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04463992</url>
  </required_header>
  <id_info>
    <org_study_id>57643</org_study_id>
    <nct_id>NCT04463992</nct_id>
  </id_info>
  <brief_title>Lay Health Worker Expanded Intervention in Community Oncology Practices</brief_title>
  <official_title>Lay Health Worker Expanded Intervention in Community Oncology Practices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Undertreated patient symptoms and resulting acute care use require approaches that improve&#xD;
      symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was&#xD;
      developed for patients with cancer. In pilot work, the intervention was associated with&#xD;
      improvements in patient symptom burden and reductions in healthcare use and costs of care at&#xD;
      the end of life. This intervention will be expanded across several clinics to evaluate the&#xD;
      impact of the LHW intervention on with cancer and the LHW will be trained to refer patients&#xD;
      to palliative care. This randomized intervention will evaluate the effect on healthcare use,&#xD;
      total costs, palliative care and hospice referral.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients with newly diagnosed cancer, over the age of 75 with a medical record number&#xD;
      ending in an odd number up to 200 patients will be included in the CareMore Pilot 2 Program.&#xD;
      Any patients who decline to participate will be excluded from the 200 patients in the&#xD;
      CareMore Pilot 2 Program. The first 200 patients who do not qualify will be the control&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)</measure>
    <time_frame>12 months after patient enrollment</time_frame>
    <description>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 the % of patients with emergency department visits between study arms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)</measure>
    <time_frame>12 months after patient enrollment</time_frame>
    <description>Hospitalization 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 hospitalizations between the two study arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)</measure>
    <time_frame>12 months after patient enrollment</time_frame>
    <description>Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Health Care Costs (Claims Review)</measure>
    <time_frame>12 months after patient enrollment</time_frame>
    <description>Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of patients with an Acute Care Facility Death (Chart Review)</measure>
    <time_frame>30 days prior to death for patients who died at 12-months follow-up</time_frame>
    <description>Acute Care Facility Deaths for each patient will be abstracted by electronic medical record chart review and claims review for each patient who has died at 12-months followup. We will evaluate comparisons of Acute Care Facility Deaths between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of patients with Emergency Department Visit in the last 30 days of life (Chart Review)</measure>
    <time_frame>30 days prior to death for patients who died at 12-months follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of patients with Hospitalization Visits in the last 30 days of life (Chart Review)</measure>
    <time_frame>30 days prior to death for patients who died at 12-months follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of patients with a Hospice Consult in the last 30 days of life (Chart Review)</measure>
    <time_frame>30 days prior to death for patients who died at 12-months follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Costs of Care (Claims Review)</measure>
    <time_frame>30 days prior to death for patients who died at 12-months follow-up</time_frame>
    <description>Total costs of care for each patient will be obtained through claims data for each patient for each patient who has died. We will evaluate comparisons of Total costs of care between study arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>End of Life</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention Group Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Behavioral:Program participants</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group arm will receive usual care as provided by their local oncologists.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Program participants</intervention_name>
    <description>The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.</description>
    <arm_group_label>Intervention Group Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Usual care as provided by local oncologists</description>
    <arm_group_label>Behavioral:Program participants</arm_group_label>
    <arm_group_label>Intervention Group Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed or relapsed cancer diagnosis.&#xD;
&#xD;
          -  75 years or older with an odd medical record #&#xD;
&#xD;
          -  Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by&#xD;
             imaging or biopsy and confirmed by physician.&#xD;
&#xD;
          -  Must have capacity to verbally consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to consent to the study due to lack of capacity as documented by the&#xD;
             referring physician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manali I Patel, MD MPH MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 8, 2022</last_update_submitted>
  <last_update_submitted_qc>July 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Manali Indravadan Patel</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>cancer end of life patient-centered</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04463992
org study id: 57643
nct id: NCT04463992
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Undertreated patient symptoms and resulting acute care use require approaches that improve
      symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was
      developed for patients with cancer. In pilot work, the intervention was associated with
      improvements in patient symptom burden and reductions in healthcare use and costs of care at
      the end of life. This intervention will be expanded across several clinics to evaluate the
      impact of the LHW intervention on with cancer and the LHW will be trained to refer patients
      to palliative care. This randomized intervention will evaluate the effect on healthcare use,
      total costs, palliative care and hospice referral.
All patients with newly diagnosed cancer, over the age of 75 with a medical record number
      ending in an odd number up to 200 patients will be included in the CareMore Pilot 2 Program.
      Any patients who decline to participate will be excluded from the 200 patients in the
      CareMore Pilot 2 Program. The first 200 patients who do not qualify will be the control
      group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: % of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
time frame: 12 months after patient enrollment
description: 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 the % of patients with emergency department visits between study arms.
measure: % of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)
time frame: 12 months after patient enrollment
description: Hospitalization 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 hospitalizations between the two study arms.
measure: % of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)
time frame: 12 months after patient enrollment
description: Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
measure: Total Health Care Costs (Claims Review)
time frame: 12 months after patient enrollment
description: Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.
measure: % of patients with an Acute Care Facility Death (Chart Review)
time frame: 30 days prior to death for patients who died at 12-months follow-up
description: Acute Care Facility Deaths for each patient will be abstracted by electronic medical record chart review and claims review for each patient who has died at 12-months followup. We will evaluate comparisons of Acute Care Facility Deaths between study arms.
measure: % of patients with Emergency Department Visit in the last 30 days of life (Chart Review)
time frame: 30 days prior to death for patients who died at 12-months follow-up
description: 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.
measure: % of patients with Hospitalization Visits in the last 30 days of life (Chart Review)
time frame: 30 days prior to death for patients who died at 12-months follow-up
description: 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.
measure: % of patients with a Hospice Consult in the last 30 days of life (Chart Review)
time frame: 30 days prior to death for patients who died at 12-months follow-up
description: 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.
measure: Total Costs of Care (Claims Review)
time frame: 30 days prior to death for patients who died at 12-months follow-up
description: Total costs of care for each patient will be obtained through claims data for each patient for each patient who has died. We will evaluate comparisons of Total costs of care between study arms.
arm group label: Intervention Group Arm
arm group type: Experimental
description: Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months.
arm group label: Behavioral:Program participants
arm group type: Active Comparator
description: The control group arm will receive usual care as provided by their local oncologists.
intervention type: Behavioral
intervention name: Program participants
description: The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.
arm group label: Intervention Group Arm
intervention type: Other
intervention name: Usual Care
description: Usual care as provided by local oncologists
arm group label: Behavioral:Program participants
arm group label: Intervention Group Arm
criteria: 
gender: All
minimum age: 75 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Manali I Patel, MD MPH MS
role: Principal Investigator
affiliation: Stanford University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Manali Indravadan Patel
investigator title: Assistant Professor
mesh term: Death
sharing ipd: No