Influenza Clinical Trial
Official title:
Test of the PING/INDIVO Personal Health Record System at MIT
The purpose of this project is to evaluate the effects on influenza related knowledge, attitudes and behaviors of exposure to tailored/targeted health messages and contextualized information about influenza like illness delivered to subjects through a personally controlled health record system. The main study hypothesis is that exposure to more intensive levels of personalized and contextualized information about risk will result in increased knowledge about influenza, greater attributions of immunization safety and efficacy, improved health protecting behaviors including higher levels of appropriate immunization.
The goal of our work is to test an information infrastructure that creates a three-way link
among individuals, health care providers and public health authorities, testing the efficacy
of this system for improving the prevention and control of influenza. Our model comprises a
full feedback system in which an electronic personally controlled health record (PCHR)
provides a primary data source for population-based surveillance and a vehicle for delivery
of health promotion messages, in this case about influenza immunization and control. This
system will feed into and draw on data from a statewide real-time influenza surveillance
system, and be integrated with hospital/provider data systems, forming the three-way link.
The influenza pandemic is a "great global infectious disease threat" {Osterholm, 2005} for
which we are ill prepared. With limited vaccine supply for the past two years and probably
next year as well, it is critical to: understand who should be vaccinated to ameliorate
population-wide transmission; have effective channels for delivering health directives to
high risk groups; monitor efficacy. We will deploy and test our three-way link model and
PCHR record system in a multisite study and evaluate using a randomized controlled design
the effects on immunization rates of tailored messages about influenza immunization
delivered to patients through the electronic health record. Our focus is children ages 6
months to ten years of age and their household members (two of four settings), all age
groups including children and working adults (two settings), and university students/staff
(one setting). The specific aims follow.
Aim 1.To leverage an electronic personally controlled health record as a public health tool,
establishing three way communication systems among individuals, health systems, and public
health agencies. We will establish a formal mechanism for patients to integrate and share
healthcare-based and personally entered information. Individuals can share information from
their medical record, and in response to surveys delivered through the system. There will be
two way communications between the record and the State Immunization Registry. Particular
attention will be paid to information security, compliance with the Health Insurance
Portability and Accountability Act (HIPAA) privacy rule, and personal control. Primary
measurements include the structural integrity of the information system, use and usability
of the system, and user acceptance. The main hypothesis to be tested is that people are
generally willing to share their personally controlled data to promote personal and public
health.
Aim 2. To adapt a traditional syndromic surveillance system, initially designed as an early
detector of outbreaks, to nimbly identify patients to be targeted for behavior change
through personally controlled electronic records. We will develop health messages as cues to
action, directed at improving individual compliance with influenza prevention, calibrating
our detection models to identify high risk groups, based on demographic and clinical data
contained in personal health records. Messages will be targeted at appropriate risk groups
and contain information tailored to the individual's characteristics. The primary focus will
be to encourage influenza immunization when indicated and conversely, to encourage delay in
immunization under conditions of low risk and scarcity. We will change the content, tempo,
and targets of the messages based on real time influenza surveillance. The main hypothesis
to be tested is that a real-time surveillance system can be used to calibrate health
messaging. A second hypothesis is that sentinel individuals can provide data to surveillance
systems that adds value to what is already collected.
Aim 3. To measure the impact on immunization rates of tailored health messages, linked to
surveillance, and delivered through a personal health record. We will evaluate the impact of
directed communications delivered to randomly selected study participants through a personal
health record on influenza vaccination rates comparing them to rates among control
participants. Secondary outcomes will include message impacts on rates of self-reported
illness, knowledge, attitudes and beliefs about influenza and immunization efficacy, use of
recommended health protective behaviors. We will investigate the impacts on technology use
and immunization rates of a range of individual social demographic characteristics,
household characteristics, and computing-related factors that may influence the
acceptability of the proposed technology and/or target health behaviors. The main hypothesis
to be tested is that individuals exposed to tailored health messages delivered through a
PCHR will have higher influenza immunization rates than their unexposed peers. Secondary
hypotheses are that compliance will be moderated by computing experience,
acceptability/accessibility, individual demographics (e.g., age, sex, race/ethnicity, social
class) social and scheduling supports (e.g., work/time schedule flexibility) , family health
factors, and logistical factors (transportation, ease of access to immunization sites,
convenience, clear scheduling/notification and minimal waiting time for services).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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