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临床试验/NCT04323137
NCT04323137已完成不适用

Encouraging Flu Vaccination Among High-Risk Patients Identified by a Machine-Learning Model of Flu Complication Risk

Geisinger Clinic2 个研究点 分布在 1 个国家目标入组 117,649 人开始时间: 2020年9月21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
117,649
试验地点
2
主要终点
Flu Vaccination Rate

研究概览

简要总结

The purpose of the current study is to test different interventions to determine the most effective way to promote flu vaccine uptake in a high-risk population identified by an "artificial intelligence" (AI) or machine learning (ML) algorithm. The specific aims are:

  1. Evaluate the effect on flu vaccination rates of informing health-system patients who are identified by an ML analysis of EHR data to be at high risk for flu complications that they are at high risk with either (a) no additional explanation, (b) an explanation that this determination comes from an analysis of their medical records, and (c) the additional explanation that an AI or ML algorithm made this determination.
  2. Evaluate the effects of the same three interventions on diagnoses of flu in the same patients.

详细描述

Background

On average, 8% of the US population gets sick from flu each flu season (Tokars et al. 2018). Since 2010, the annual disease burden of influenza has included 9-45 million illnesses, 140,000-810,000 hospitalizations, and 12,000-61,000 deaths (CDC 2020). The CDC recommends the flu vaccination to everyone aged 6+ months, with rare exception; almost anyone can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death (CDC 2019a). Flu vaccination will be especially important for high-risk patients during the COVID-19 pandemic so that flu cases are reduced and resources conserved.

While most recover from influenza without treatment, the elderly, those with comorbidities, and other high-risk individuals can experience complications such as pneumonia, other respiratory illness, and death. Geisinger, a large health system in Pennsylvania and New Jersey, has partnered with Medial EarlySign (Medial; www.earlysign.com) to develop a machine learning (ML) algorithm to identify patients at risk for serious (moderate to severe) flu-associated complications on the basis of their existing electronic health record (EHR) data. Geisinger will deploy this system during the 2020-21 flu season and contact the identified patients with special messages (in addition to standard efforts made by the health system every flu season) to encourage vaccination. Flu vaccination will be especially important for high-risk patients during the COVID-19 pandemic so that flu cases are reduced and resources conserved.

Published results suggest Medial's ML systems identify high-risk patients in other contexts (Goshen et al., 2018; Zack et al., 2019). However, there is little evidence about (a) whether informing patients they are at high risk makes them more likely to receive vaccination; (b) how patients react to being told their risk status is the result of an analysis of their health records; and (c) whether informing patients their risk status has been determined by an "algorithm," by "machine learning," and/or by "artificial intelligence" will increase or decrease their likelihood of getting vaccinated. This study will address these gaps in the literature, which are especially important in light of the anticipated future growth of AI/ML system use throughout healthcare.

Medial's algorithm is an example of how interoperable health information exchange (HIE)-the ability for health information technology to share patient data-can improve the efficiency and effectiveness of healthcare. However, patients may not appreciate these benefits or the fact that healthcare has become substantially more integrated and collaborative. A systematic review of patient privacy concerns about HIE found that 15-74% of patients expressed privacy concerns, depending on the study, and concluded that patient perspectives remain poorly understood. A flu outreach message that explicitly references a review of patient medical records might backfire as patients react badly to a sense they have lost control of their health records.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

盲法说明

Participants (i.e., patients) will not be informed specifically of their assignment to different arms throughout the study. Providers who prescribe vaccination and diagnose conditions will not be randomized to study arms or informed of patient assignment.

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current Geisinger patient at the time of study
  • Falls in the top 10% of patients at highest risk, as identified by the flu-complication risk scores of Medial's machine learning algorithm (which operates on coded EHR data)
  • May limit inclusion to patients that are under Geisinger primary care, depending on algorithm performance of patients who have non-Geisinger PCPs

排除标准

  • Has contraindications for flu vaccination
  • Has opted out of receiving communications from Geisinger via all of the modalities being tested

结局指标

主要结局

Flu Vaccination Rate

时间窗: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration

Patient received a flu vaccination

Flu Vaccination Rate by Risk Level

时间窗: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration

Patient received a flu vaccination Note: For patients who received risk communications, those in the top 3% were always told they were in the top 3% of risk. Those in the top 4-10% of risk were randomized to be told that they were in the top 10% of risk or high risk. Control patients in the top 3% and top 4-10% of risk were allocated to the top 3% and randomized to either top 10% or high risk groups, respectively, at the same time as those in the patient contact groups, even though these control patients were not contacted.

High Confidence Flu Diagnosis Rate

时间窗: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration

Patient received a flu diagnosis via a positive PCR/antigen/molecular test

次要结局

  • "Likely Flu" Diagnosis Among Those at Sub-threshold Risk(Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration)
  • Flu Complications Among Those at Sub-threshold Risk(Through 3 months after the end of the flu season (August 31st 2021), approximately 12 months assessment duration)
  • High Confidence Flu Diagnosis Among Fellow Household Members(Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration)
  • Flu Complications Rate(Through 3 months after the end of the flu season (August 31st 2021), approximately 12 months assessment duration)
  • Change in ER Visits From Pre- to Post-intervention(Within 12 months pre-intervention (Time 1) and within 12 months post-intervention (Time 2))
  • Change in Hospitalizations From Pre- to Post-intervention(Within 12 months pre-intervention (Time 1) and within 12 months post-intervention (Time 2))
  • Flu Complications Among Fellow Household Members(Through 3 months after the end of the flu season (August 31st 2021), approximately 12 months assessment duration)
  • Flu Vaccination Among Those at Sub-threshold Risk(Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration)
  • "Likely Flu" Diagnosis Rate(Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration)
  • Flu Vaccination Among Fellow Household Members(Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration)
  • "Likely Flu" Diagnosis Among Fellow Household Members(Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration)
  • High Confidence Flu Diagnosis Among Those at Sub-threshold Risk(Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration)

研究者

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

Christopher F Chabris, PhD

Faculty Co-Director, Behavioral Insights Team

Geisinger Clinic

研究点 (2)

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