Testing a Personally Controlled Health Record to Ameliorate Influenza at MIT

Influenza Clinical Trial

— Indivo at MIT  

Official title:

Test of the PING/INDIVO Personal Health Record System at MIT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531700
• Other study ID #: 06-07-0347
• Status: Completed
• Phase: N/A
• First received: September 18, 2007
• Last updated: April 30, 2009
• Start date: October 2007
• Est. completion date: January 2009

Study information

• Verified date: April 2009
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: January 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ages 18 and over

• English speaker

• Affiliated with study site

Exclusion Criteria:

• Younger than 18

• No access to computers or the internet

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Other:
• Health messaging
Combinations of personalized health messages (tailored/targeted) and contextualized health messages (reports about localized epidemiologic risk) will be delivered to subjects
• Health messages
community level health messages unrelated to the study originating exposures

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	appropriate immunization behavior		six months	Yes
Secondary	reduced presenteeism for school and work		six months	Yes
Secondary	appropriate immunization behaviors for close household/family members		six months	Yes
Secondary	knowledge about influenza and beliefs about influenza risk and transmission		six months	No