Lay Health Worker Led Symptom Assessment Intervention

Cancer Clinical Trial

Official title:

Joint Oncology Collaboration for Proactive Symptom Assessments by a Lay Health Worker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737058
• Other study ID #: SU12
• Status: Completed
• Start date: November 1, 2015
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rising costs and poor patient experiences from under-treated symptoms have led to the demand for approaches that improve patients' experiences and lower expenditures. This observational project assigned a lay health worker to concuct proactive symptom assessments intended to achieve these goals among patients with advanced cancer.

Description:

All newly diagnosed Medicare Advantage enrollees with Stage 3 or 4 solid tumors or hematologic malignancies who planned to receive all oncology care at the Oncology Institute of Hope and Innovation from 11/1/2015 through 9/30/2016 were enrolled in the program. The program consisted of 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) with the frequency of symptom assessment varying based on patient risk. We evaluated feasibility, defined as monthly LHW documentation of symptom assessments, and change in patient-reported satisfaction and overall and emotional and mental health with validated assessments at enrollment and 5-months post-enrollment among patients in the intervention. We compared healthcare use and costs to a historical cohort of similar Medicare Advantage enrollees diagnosed between 11/1/2014-10/31/2015 (control). We assessed differences in demographic and clinical factors between the two groups using chi-square and t-tests and used generalized linear models to evaluate differences in healthcare use and costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of stage 3 and 4 cancer

2. Clinical diagnosis of hematologic malignancy

3. Must receive care at the Oncology Institute of Hope and Innovation

4. Must be an enrollee of CareMore Medicare Advantage Exclusion Criteria: None

Related Conditions & MeSH terms

• Cancer

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 Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients with symptom assessment documentation	% of patients with at least monthly symptom assessments documented in the electronic health record for at least 12 months for until death	12 months after patient enrollment
Secondary	Emergency Department Visit (Claims Review)	Emergency Department Use 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	Hospitalization Visits (Claims Review)	Hospitalization Use 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	Intensive Care Unit Visits (Claims Review)	Intensive Care Unit Visits 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	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	Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey	Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 5 months. We will measure the change in satisfaction from baseline to 5 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 12 months.	Change in Patient Satisfaction with Care from baseline to 12 months.