Lay Health Worker Led Symptom Assessment Intervention

NCT03737058 | Completed Results

• 1 other identifier: SU12
• Study Type: observational
• Target: 288
• Locations: 0 countries
• Sites: N/A

Brief 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 conduct proactive symptom assessments intended to achieve these goals among patients with advanced cancer.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Edmonton Symptom Assessment Scale Score (ESAS)

  ESAS measures participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).

  12 months after patient enrollment

Secondary Outcomes (5)

• Incidence of Emergency Department Visits

  12 months after patient enrollment

• Hospitalization Visits (Claims Review)

  12 months after patient enrollment

• Intensive Care Unit Visits (Claims Review)

  12 months after patient enrollment

• Total Health Care Costs (Claims Review)

  12 months after patient enrollment

• Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey

  Change in Patient Satisfaction with Care from baseline to 5 months.

Interventions

Program participants BEHAVIORAL

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who have a diagnosis of stage 3 and 4 cancers and who are receiving care at the Oncology Institute of Hope and Innovation and have CareMore Medicare Advantage as their healthcare payer plan.

You may qualify if:

• Clinical diagnosis of stage 3 and 4 cancer
• Clinical diagnosis of hematologic malignancy
• Must receive care at the Oncology Institute of Hope and Innovation
• Must be an enrollee of CareMore Medicare Advantage

You may not qualify if:

• None

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Neoplasms

Limitations and Caveats

The study was limited to one community oncology practice and to a Medicare Advantage population.

Results Point of Contact

• Title: Manali I Patel, MD MPH MS
• Organization: Stanford University School of Medicine

manalip@stanford.edu

650-723-4000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 9, 2018
• Study Start: November 1, 2015
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02