Encouraging Flu Vaccination Among High-Risk Patients Identified by a Machine-Learning Model of Flu Complication Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117,649
- 试验地点
- 1
- 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:
- 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.
- 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
- 否
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
研究组 & 干预措施
High risk based on medical records
This group receives messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records.
干预措施: Risk reduction (Behavioral)
High risk based on medical records
This group receives messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records.
干预措施: Medical records-based recommendation (Behavioral)
Control
This group receives no additional pro-vaccination intervention beyond the health system's normal efforts. Although some patients are currently targeted for flu vaccination encouragement due to a non-ML assessment that they are at high risk for complications, these patients are not told that they are at high risk or that they have been targeted.
High risk only
This group receives messages telling them they have been identified to be at high risk for flu complications without specifying how or why the health system believes this to be the case.
干预措施: Risk reduction (Behavioral)
High risk based on algorithm
This group receives messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records by an AI/ML system.
干预措施: Risk reduction (Behavioral)
High risk based on algorithm
This group receives messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records by an AI/ML system.
干预措施: Medical records-based recommendation (Behavioral)
High risk based on algorithm
This group receives messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records by an AI/ML system.
干预措施: Algorithm-based recommendation (Behavioral)
Sub-threshold patients
Patients in this group is in the top 11-20% of risk for flu and complications, slightly lower risk than those included in the intervention, who are in the top 10% of risk for flu and complications. This group of patients does not receive an intervention, but are monitored for flu shots as a comparison to target patients.
Household members
This group of patients share an address with target high-risk patients (in arms 1-4). This group does not receive an intervention but is monitored for spillover effects of the intervention.
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
Christopher F Chabris, PhD
Faculty Co-Director, Behavioral Insights Team
Geisinger Clinic
