Lay Health Worker Expanded Intervention in Community Oncology Practices

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; End of Life
• Intervention / Treatment: Other: Usual Care; Behavioral: Program participants

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • The Oncology Institute of Hope and Innovation
  • Nevada
    • Henderson, Nevada, United States, 89052
      • The Oncology Institute of Hope and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group Arm; 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.	Other: Usual Care; Usual care as provided by local oncologists; Behavioral: Program participants; 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.
Active Comparator: Behavioral:Program participants; The control group arm will receive usual care as provided by their local oncologists.	Other: Usual Care; Usual care as provided by local oncologists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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.	12 months after patient enrollment
% 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.	12 months after patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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.	12 months after patient 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.	12 months after patient 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.	30 days prior to death for patients who died at 12-months follow-up
% 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.	30 days prior to death for patients who died at 12-months follow-up
% 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.	30 days prior to death for patients who died at 12-months follow-up
% 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.	30 days prior to death for patients who died at 12-months follow-up
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.	30 days prior to death for patients who died at 12-months follow-up

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Manali I Patel, MD MPH MS, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 4, 2020
• First Submitted That Met QC Criteria: July 4, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cancer end of life patient-centered
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: 57643

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No