Lay Health Worker Expanded Intervention in Community Oncology Practices

Not Applicable

Completed

• Conditions: Cancer; End of Life
• Interventions: Behavioral: Program participants; Other: Usual Care

• Registration Number: NCT04463992
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2020-07-04
• Study First Submitted QC: 2020-07-04
• Study First Posted: 2020-07-09
• Study Start: 2020-10-05
• Status Verified: 2024-10
• Primary Completion: 2024-10-17
• Study Completion: 2024-10-17
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

• Newly diagnosed or relapsed cancer diagnosis.
• 75 years or older
• 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

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Exclusion Criteria

• Inability to consent to the study due to lack of capacity as documented by the referring physician.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group Arm	Usual Care	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.
Intervention Group Arm	Program participants	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.
Behavioral:Program participants	Usual Care	The control group arm will receive usual care as provided by their local oncologists.

Primary Outcome Measures

Name	Time	Method
% of patients with Emergency Department Visit within 12-months after patient enrollment (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 the % of patients with emergency department visits between study arms.
% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)	12 months after patient enrollment	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

Name	Time	Method
% of patients with an Acute Care Facility Death (Chart Review)	30 days prior to death for patients who died at 12-months follow-up	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.
Total Costs of Care (Claims Review)	30 days prior to death for patients who died at 12-months follow-up	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.
Total Health Care Costs (Claims Review)	12 months after patient enrollment	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 Hospitalization Visits in the last 30 days of life (Chart Review)	30 days prior to death for patients who died at 12-months follow-up	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 within 12-months after patient enrollment (Chart Review)	12 months after patient enrollment	Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
% of patients with Emergency Department Visit in the last 30 days of life (Chart Review)	30 days prior to death for patients who died at 12-months follow-up	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 a Hospice Consult in the last 30 days of life (Chart Review)	30 days prior to death for patients who died at 12-months follow-up	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.

Trial Locations

Locations (1)

The Oncology Institute of Hope and Innovation; 🇺🇸 Henderson, Nevada, United States