Lay Health Worker Expanded Intervention in Community Oncology Practices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 416
- Locations
- 3
- Primary Endpoint
- % of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 75 Years to 100 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)
Time Frame: 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)
Time Frame: 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 Outcomes
- Total Health Care Costs (Claims Review)(12 months after patient enrollment)
- % of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)(12 months after patient enrollment)
- % of patients with an Acute Care Facility Death (Chart Review)(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)(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)(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)(30 days prior to death for patients who died at 12-months follow-up)
- Total Costs of Care (Claims Review)(Time of enrollment to 12 months followup or death, whichever is first)
Investigators
Manali Indravadan Patel
Assistant Professor
Stanford University