InfluenzaNCT01146899
FluAlert: Influenza Vaccine Alerts for Providers in the Electronic Health Record
A study testing Provider Alert in people with Influenza, run by Columbia University at 1 site in United States.
Trial summary
Childhood influenza coverage rates are far below rates for the other childhood vaccinations. Increasing influenza vaccine coverage rates is important not only for the health of the child, but for that of the child's household and community. Read more about this study
- Who is it for?
- Ages 6 months to 75 years
- Conditions the study is for
- Influenza
- What is being tested?
- Provider Alert
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,145 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2013
- 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 6 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medical (medical doctor/nurse practitioner (MD/NP)) or nursing providers (registered nurse, licensed practical nurse (RN/LPN)) at participating practices
- Parents of a child 6 months - 18 years who is a patient at one of the participating ACN practice
- Parents fluent in English or Spanish
- Children 6 months- 18 years with visit to participating practice during influenza season
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center/ NewYork Presbyterian Hospital Ambulatory Care Network
New York, New York, 10032
About this study
Childhood influenza coverage rates are far below rates for the other childhood vaccinations. Increasing influenza vaccine coverage rates is important not only for the health of the child, but for that of the child's household and community. Yet,influenza vaccine delivery rates at pediatric clinics are low, even when the vaccine is available. The proposed project will take advantage of existing health information technology to tailor, implement and evaluate influenza vaccine alerts in the electronic health record (EHR) for pediatric providers to help improve health care decision making.
- Conditions
- Influenza
- Being tested
- Provider Alert
- Keywords
- influenza, vaccine, clinical decision support
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider AlertOther
Also called alert for provider in electronic health record
Provider influenza vaccine alert
| Study group | Role | What they receive |
|---|---|---|
| Provider Alert | Experimental | Provider receives alert for patient visit Receives: Other: Provider Alert |
| No Alert | No intervention | No alert provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
influenza vaccination
Measured: September through March 2011-2012
Secondary outcomes (1)
Documentation of reason for vaccine refusal
Measured: Sept 2011-March 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Melissa Stockwell, MD, MPH, Columbia University
- Investigators
- Melissa S Stockwell, MD MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146899
- Sponsor's protocol ID
- AAAE4956
- Other IDs
- 1R18HS018158-01
- Status last verified
- Jun 2014
- First submitted
- 16 Jun 2010
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Stockwell MS, Catallozzi M, Camargo S, Ramakrishnan R, Holleran S, Findley SE, Kukafka R, Hofstetter AM, Fernandez N, Vawdrey DK. Registry-linked electronic influenza vaccine provider reminders: a cluster-crossover trial. Pediatrics. 2015 Jan;135(1):e75-82. doi: 10.1542/peds.2014-2616.
PubMed 25548331
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FluAlert: Influenza Vaccine Alerts for Providers in the Electronic Health Record
- ClinicalTrials.gov ID
- NCT01146899
- Acronym / sponsor ID
- AAAE4956
- Conditions
- Influenza
- Keywords
- influenza, vaccine, clinical decision support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,145 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Dec 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Jun 2010 (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.
Childhood influenza coverage rates are far below rates for the other childhood vaccinations. Increasing influenza vaccine coverage rates is important not only for the health of the child, but for that of the child's household and community. Yet,influenza vaccine delivery rates at pediatric clinics are low, even when the vaccine is available. The proposed project will take advantage of existing health information technology to tailor, implement and evaluate influenza vaccine alerts in the electronic health record (EHR) for pediatric providers to help improve health care decision making.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider Alert | Experimental | Other: Provider AlertProvider receives alert for patient visit |
| No Alert | No intervention | –No alert provided |
Who may qualify
- Ages
- 6 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Medical (medical doctor/nurse practitioner (MD/NP)) or nursing providers (registered nurse, licensed practical nurse (RN/LPN)) at participating practices
- Parents of a child 6 months - 18 years who is a patient at one of the participating ACN practice
- Parents fluent in English or Spanish
- Children 6 months- 18 years with visit to participating practice during influenza season
Key exclusion criteria (0 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 |
|---|---|---|
| Provider AlertAlso: alert for provider in electronic health recordProvider influenza vaccine alert | Other | Provider Alert |
Primary outcome
influenza vaccination
Time frame: September through March 2011-2012
1 secondary outcome
Documentation of reason for vaccine refusal
Time frame: Sept 2011-March 2012
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 24 Jun 2014.
- Derived from this study: PubMed 25548331Stockwell MS, Catallozzi M, Camargo S, Ramakrishnan R, Holleran S, Findley SE, Kukafka R, Hofstetter AM, Fernandez N, Vawdrey DK. Registry-linked electronic influenza vaccine provider reminders: a cluster-crossover trial. Pediatrics. 2015 Jan;135(1):e75-82. doi: 10.1542/peds.2014-2616.
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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.
Melissa S Stockwell, MD MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Alert in people with Influenza, run by Columbia University 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 4 inclusion and 0 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 24 Jun 2014. 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?
influenza vaccination (time frame: September through March 2011-2012). 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 NCT01146899, which also lists 1 linked publication.
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 24 Jun 2014.