Clinical trial NCT04463992: Lay Health Worker Expanded Intervention in Community Oncology Practices
Official title: Lay Health Worker Expanded Intervention in Community Oncology Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End of Life
Cancer
Keywords: cancer end of life patient-centered
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 416
Sex: ALL
Minimum age (years): 75
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: % of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
timeFrame: 12 months after patient enrollment
measure: % of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)
timeFrame: 12 months after patient enrollment
Secondary outcomes:
measure: % of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Total Health Care Costs (Claims Review)
timeFrame: 12 months after patient enrollment
measure: % of patients with an Acute Care Facility Death (Chart Review)
timeFrame: 30 days prior to death for patients who died at 12-months follow-up
measure: % of patients with Emergency Department Visit in the last 30 days of life (Chart Review)
timeFrame: 30 days prior to death for patients who died at 12-months follow-up
measure: % of patients with Hospitalization Visits in the last 30 days of life (Chart Review)
timeFrame: 30 days prior to death for patients who died at 12-months follow-up
measure: % of patients with a Hospice Consult in the last 30 days of life (Chart Review)
timeFrame: 30 days prior to death for patients who died at 12-months follow-up
measure: Total Costs of Care (Claims Review)
timeFrame: Time of enrollment to 12 months followup or death, whichever is first
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The Oncology Institute of Hope and Innovation
state: Arizona
city: Henderson
country: United States
facility: The Oncology Institute of Hope and Innovation
state: Nevada
Study officials:
affiliation: Stanford University
name: Manali I Patel, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References: