InfluenzaNCT00142077
Electronic Health Records for Health Promotion
A study testing Electronic health record and messaging system in people with Influenza, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Electronic health record and messaging system
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is a part-time or full-time employee at a major corporation.
- The subject is eighteen years of age or older.
- The subject is comfortable reading and writing in English.
- The subject has reliable internet access at home, at school, or at work.
- The subject uses email regularly (i.e. at least once every 2 days)
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02116
About this study
Official title: Health Promotion in the Workplace Using Personally Controlled Health Records
The purpose of this study is to determine whether personally controlled electronic health records can be used for health promotion in a workplace setting.
Read the detailed 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.
- Conditions
- Influenza
- Being tested
- Electronic health record and messaging system
- Keywords
- Influenza, Electronic health record, Behavior modification
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic health record and messaging systemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
- Rate of influenza immunization among subjects
Secondary outcomes (4)
Change in knowledge, attitutes, and beliefs regarding influenza and influenza immunization.
Changes in health behaviors around influenza (e.g. hand washing and cough etiquette).
General health outcomes related to respiratory illnesses (e.g. number of influenza-like illnesses, number of physician visits, number of missed work days).
Rate of influenza immunization among subject household members.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startOct 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 700 participants
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Kenneth D Mandl, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142077
- Sponsor's protocol ID
- 1 R01 CDC 000065-01
- Status last verified
- Jan 2006
- First submitted
- 31 Aug 2005
- Last updated
- 5 Apr 2007
- Results posted
- No
Publications
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. doi: 10.1001/archinte.161.5.749.
PubMed 11231710Keech 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. doi: 10.1093/occmed/48.2.85.
PubMed 9614766Harper 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.
PubMed 16086456Bridges 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. doi: 10.1001/jama.284.13.1655.
PubMed 11015795Mandl 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. doi: 10.1136/bmj.322.7281.283. No abstract available.
PubMed 11157533Riva 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. doi: 10.1016/s1386-5056(00)00136-2.
PubMed 11340004Mandl 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. doi: 10.1197/jamia.M1356. Epub 2003 Nov 21.
PubMed 14633933Heffernan 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. doi: 10.3201/eid1005.030646.
PubMed 15200820Bourgeois FT, Simons WW, Olson K, Brownstein JS, Mandl KD. Evaluation of influenza prevention in the workplace using a personally controlled health record: randomized controlled trial. J Med Internet Res. 2008 Mar 14;10(1):e5. doi: 10.2196/jmir.984.
PubMed 18343794
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion in the Workplace Using Personally Controlled Health Records
- ClinicalTrials.gov ID
- NCT00142077
- Acronym / sponsor ID
- 1 R01 CDC 000065-01
- Conditions
- Influenza
- Keywords
- Influenza, Electronic health record, Behavior modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Oct 2005
- Study completion
- May 2006 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether personally controlled electronic health records can be used for health promotion in a workplace setting.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is a part-time or full-time employee at a major corporation.
- The subject is eighteen years of age or older.
- The subject is comfortable reading and writing in English.
- The subject has reliable internet access at home, at school, or at work.
- The subject uses email regularly (i.e. at least once every 2 days)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic health record and messaging system | Device | – |
Primary outcome
- Rate of influenza immunization among subjects
4 secondary outcomes
Change in knowledge, attitutes, and beliefs regarding influenza and influenza immunization.
Changes in health behaviors around influenza (e.g. hand washing and cough etiquette).
General health outcomes related to respiratory illnesses (e.g. number of influenza-like illnesses, number of physician visits, number of missed work days).
Rate of influenza immunization among subject household members.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2007.
- Background: PubMed 11231710Nichol KL. Cost-benefit analysis of a strategy to vaccinate healthy working adults against influenza. Arch Intern Med. 2001 Mar 12;161(5):749-59. doi: 10.1001/archinte.161.5.749.
- Background: PubMed 9614766Keech 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. doi: 10.1093/occmed/48.2.85.
- Background: PubMed 16086456Harper 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.
- Background: PubMed 11015795Bridges 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. doi: 10.1001/jama.284.13.1655.
- Background: PubMed 11157533Mandl 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. doi: 10.1136/bmj.322.7281.283. No abstract available.
- Background: PubMed 11340004Riva 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. doi: 10.1016/s1386-5056(00)00136-2.
- Background: PubMed 14633933Mandl 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. doi: 10.1197/jamia.M1356. Epub 2003 Nov 21.
- Background: PubMed 15200820Heffernan 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. doi: 10.3201/eid1005.030646.
- Derived from this study: PubMed 18343794Bourgeois FT, Simons WW, Olson K, Brownstein JS, Mandl KD. Evaluation of influenza prevention in the workplace using a personally controlled health record: randomized controlled trial. J Med Internet Res. 2008 Mar 14;10(1):e5. doi: 10.2196/jmir.984.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth D Mandl, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic health record and messaging system in people with Influenza, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Rate of influenza immunization among subjects. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00142077, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2007.