FluAlert: Influenza Vaccine Alerts for Providers in the E... | NCT01146899

Studies
FluAlert: Influenza Vaccine Alerts for Providers in the Electronic Health Record

NCT01146899

Sponsor

Columbia University

Status

Completed

Last Update Posted

Jun 24, 2014Estimated

Enrollment

6,145Actual

Phase

Not Applicable

Conditions

Influenza

Interventions

Provider Alert

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R18HS018158-01	U.S. AHRQ Grant/Contract		View source

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Mar 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jun 16, 2010

First Submission Date that Met QC Criteria

Jun 16, 2010

First Posted Date

Jun 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2014

Last Update Posted Date

Jun 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Melissa Stockwell, MD, MPH, Asst Prof of Pediatrics and Population and Family Health, Columbia UniversityPrincipal Investigator

Lead Sponsor

Columbia UniversityOTHER

Collaborators

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6,145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Provider Alert	Experimental	Provider receives alert for patient visit	Other: Provider Alert
No Alert	No Intervention	No alert provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Provider Alert	Other	Provider influenza vaccine alert	Provider Alert

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
influenza vaccination		September through March 2011-2012

Secondary Outcomes

Measure	Description	Time Frame
Documentation of reason for vaccine refusal		Sept 2011-March 2012

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Melissa S Stockwell, MD MPH	Columbia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Medical Center/ NewYork Presbyterian Hospital Ambulatory Care Network		New York	New York	10032	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25548331	Derived	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.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

ID	Term
D002110	Caffeine
D057286	Electronic Health Records

ID	Term
D014970	Xanthines
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011688	Purinones