Electronic Health Records for Health Promotion

Influenza Clinical Trial

Official title:

Health Promotion in the Workplace Using Personally Controlled Health Records

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142077
• Other study ID #: 1 R01 CDC 000065-01
• Status: Completed
• Phase: N/A
• First received: August 31, 2005
• Last updated: April 4, 2007
• Start date: October 2005
• Est. completion date: May 2006

Study information

• Verified date: January 2006
• 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 study is to determine whether personally controlled electronic health records can be used for health promotion in a workplace setting.

Description:

In response to the call for research of the new Health Protection Research Initiative at the Centers for Disease Control and Prevention (CDC), we propose to adapt newly mature informatics technology to shift the paradigm for health alerting and health promotion in the workplace. The goal is to firmly ground these activities on real time information collected from and delivered to employees, in an interactive, secure, electronic environment. We will study influenza prevention and control, an archetype of public health practice requiring surveillance, communication, and timely influence of health-related behaviors. Complex information gleaned from surveillance will be processed, translated and provided to employees. The goal is to provide employees with timely, individualized health promotion messages to improve their knowledge, attitudes and beliefs regarding influenza and to increase the rate of seasonal influenza immunization for them and their household members. The approach will be evaluated in a group randomized design at several worksites of a major corporation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subject is a part-time or full-time employee at a major corporation.

2. The subject is eighteen years of age or older.

3. The subject is comfortable reading and writing in English.

4. The subject has reliable internet access at home, at school, or at work.

5. The subject uses email regularly (i.e. at least once every 2 days)

6. The subject does not have a known allergy to chicken eggs or a history of a severe reaction to an influenza vaccination in the past.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Device:
• Electronic health record and messaging system

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, 

References & Publications (8)

Bridges CB, Thompson WW, Meltzer MI, Reeve GR, Talamonti WJ, Cox NJ, Lilac HA, Hall H, Klimov A, Fukuda K. Effectiveness and cost-benefit of influenza vaccination of healthy working adults: A randomized controlled trial. JAMA. 2000 Oct 4;284(13):1655-63. — View Citation

Harper SA, Fukuda K, Uyeki TM, Cox NJ, Bridges CB; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2005 Jul 29;54(RR-8):1-40. Erratum in: MMWR Morb Mortal Wkly Rep. 2005 Aug 5;54(30):750.. — View Citation

Heffernan R, Mostashari F, Das D, Karpati A, Kulldorff M, Weiss D. Syndromic surveillance in public health practice, New York City. Emerg Infect Dis. 2004 May;10(5):858-64. Erratum in: Emerg Infect Dis. 2006 Sep;12(9):1472. — View Citation

Keech M, Scott AJ, Ryan PJ. The impact of influenza and influenza-like illness on productivity and healthcare resource utilization in a working population. Occup Med (Lond). 1998 Feb;48(2):85-90. — View Citation

Mandl KD, Overhage JM, Wagner MM, Lober WB, Sebastiani P, Mostashari F, Pavlin JA, Gesteland PH, Treadwell T, Koski E, Hutwagner L, Buckeridge DL, Aller RD, Grannis S. Implementing syndromic surveillance: a practical guide informed by the early experience. J Am Med Inform Assoc. 2004 Mar-Apr;11(2):141-50. Epub 2003 Nov 21. — View Citation

Mandl KD, Szolovits P, Kohane IS. Public standards and patients' control: how to keep electronic medical records accessible but private. BMJ. 2001 Feb 3;322(7281):283-7. — View Citation

Nichol KL. Cost-benefit analysis of a strategy to vaccinate healthy working adults against influenza. Arch Intern Med. 2001 Mar 12;161(5):749-59. — View Citation

Riva A, Mandl KD, Oh DH, Nigrin DJ, Butte A, Szolovits P, Kohane IS. The personal internetworked notary and guardian. Int J Med Inform. 2001 Jun;62(1):27-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Rate of influenza immunization among subjects
Secondary	Change in knowledge, attitutes, and beliefs regarding influenza and influenza immunization.
Secondary	Changes in health behaviors around influenza (e.g. hand washing and cough etiquette).
Secondary	General health outcomes related to respiratory illnesses (e.g. number of influenza-like illnesses, number of physician visits, number of missed work days).
Secondary	Rate of influenza immunization among subject household members.