Lay Health Worker Expanded Intervention in Community Oncology Practices
Primary Purpose
End of Life, Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Program participants
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for End of Life focused on measuring cancer end of life patient-centered
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed or relapsed cancer diagnosis.
- 75 years or older with an odd medical record #
- Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
- Must have capacity to verbally consent
Exclusion Criteria:
- Inability to consent to the study due to lack of capacity as documented by the referring physician.
Sites / Locations
- The Oncology Institute of Hope and Innovation
- The Oncology Institute of Hope and Innovation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group Arm
Behavioral:Program participants
Arm 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.
The control group arm will receive usual care as provided by their local oncologists.
Outcomes
Primary Outcome Measures
% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
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.
% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)
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.
Secondary Outcome Measures
% of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)
Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Total Health Care Costs (Claims Review)
Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.
% of patients with an Acute Care Facility Death (Chart Review)
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.
% of patients with Emergency Department Visit in the last 30 days of life (Chart Review)
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.
% of patients with Hospitalization Visits in the last 30 days of life (Chart Review)
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.
% of patients with a Hospice Consult in the last 30 days of life (Chart Review)
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.
Total Costs of Care (Claims Review)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04463992
Brief Title
Lay Health Worker Expanded Intervention in Community Oncology Practices
Official Title
Lay Health Worker Expanded Intervention in Community Oncology Practices
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
All patients with newly diagnosed cancer, over the age of 75 will be randomized into the CareMore Pilot 2 Program with 200 randomized to the intervention grou and 200 randomized to the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End of Life, Cancer
Keywords
cancer end of life patient-centered
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group Arm
Arm Type
Experimental
Arm 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 Title
Behavioral:Program participants
Arm Type
Active Comparator
Arm Description
The control group arm will receive usual care as provided by their local oncologists.
Intervention Type
Behavioral
Intervention Name(s)
Program participants
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care as provided by local oncologists
Primary Outcome Measure Information:
Title
% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
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.
Time Frame
12 months after patient enrollment
Title
% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)
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.
Time Frame
12 months after patient enrollment
Secondary Outcome Measure Information:
Title
% of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)
Description
Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Time Frame
12 months after patient enrollment
Title
Total Health Care Costs (Claims Review)
Description
Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.
Time Frame
12 months after patient enrollment
Title
% of patients with an Acute Care Facility Death (Chart Review)
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.
Time Frame
30 days prior to death for patients who died at 12-months follow-up
Title
% of patients with Emergency Department Visit in the last 30 days of life (Chart Review)
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.
Time Frame
30 days prior to death for patients who died at 12-months follow-up
Title
% of patients with Hospitalization Visits in the last 30 days of life (Chart Review)
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.
Time Frame
30 days prior to death for patients who died at 12-months follow-up
Title
% of patients with a Hospice Consult in the last 30 days of life (Chart Review)
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.
Time Frame
30 days prior to death for patients who died at 12-months follow-up
Title
Total Costs of Care (Claims Review)
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.
Time Frame
30 days prior to death for patients who died at 12-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed or relapsed cancer diagnosis.
75 years or older with an odd medical record #
Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
Must have capacity to verbally consent
Exclusion Criteria:
Inability to consent to the study due to lack of capacity as documented by the referring physician.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manali I Patel, MD MPH MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Oncology Institute of Hope and Innovation
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Lay Health Worker Expanded Intervention in Community Oncology Practices
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