Lay Health Worker Expanded Intervention in Community Oncology Practices

Cancer Clinical Trial

Official title:

Lay Health Worker Expanded Intervention in Community Oncology Practices

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04463992
• Other study ID #: 57643
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Death
• End of Life

Intervention

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.

Other:
• Usual Care
Usual care as provided by local oncologists

Locations

Country	Name	City	State
United States	The Oncology Institute of Hope and Innovation	Henderson	Nevada
United States	The Oncology Institute of Hope and Innovation	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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
Primary	% 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	% 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
Secondary	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
Secondary	% 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
Secondary	% 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
Secondary	% 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
Secondary	% 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
Secondary	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