跳至主要内容
临床试验/NCT03737058
NCT03737058已完成不适用

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

Stanford University0 个研究点目标入组 288 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
288
主要终点
Edmonton Symptom Assessment Scale Score (ESAS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Edmonton Symptom Assessment Scale Score (ESAS)

时间窗: 12 months after patient enrollment

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).

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manali Indravadan Patel

Assistant Professor

Stanford University

相似试验

Lay Health Worker Led Symptom Assessment Intervention | 临床试验