From Innovation to Solutions: Childhood Influenza Vaccination Planning
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Purpose
The purpose of this study is to increase childhood influenza vaccination rates using the FDA licensed vaccine according to national guidelines in a cluster randomized study in which offices are randomized to intervention or control with the control set becoming the intervention sites in Year 2.
| Condition | Intervention |
|---|---|
|
Influenza Vaccination Rates |
Other: 4 Pillars Toolkit for increasing childhood influenza vaccination rates |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | From Innovation to Solutions: Autodialers, Use of Early Autumn Physicals and Vaccination Assessment as a Vital Sign to Increase Childhood Influenza Vaccination in Diverse Settings |
- The main outcome variable is vaccination rates for each of the sites [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
- Secondary outcomes to be measured [ Time Frame: approximately up to three years ] [ Designated as safety issue: No ]Missed opportunities for vaccination
- Secondary outcomes to be measured [ Time Frame: approximately up to three years ] [ Designated as safety issue: No ]Vaccination rates by demographic characteristics
- Secondary outcomes to be measured [ Time Frame: approximately up to three years ] [ Designated as safety issue: No ]Acceptability and perceived usefulness of the online training program. This will be measured through an online survey to be completed by those who complete the online training program. This voluntary online training program will be sent to every office engaged in the intervention and will be distributed via the office manager to all clinical and non-clinical staff.
- Secondary outcomes to be measured [ Time Frame: approximately up to three years ] [ Designated as safety issue: No ]Clinic specific fidelity to the 4 pillars toolkit. Fidelity of implementation will be assessed by using a modified Delphi technique. The investigators will be asked to distribute 100 points across the identified measures which will be averaged to create a fidelity point system. This fidelity point system will then by used to weight those survey questions (that each intervention clinic's head doctor and nurse/practice manager will complete at the end of the season)that assess measures of the intervention.
- Secondary outcomes to be measured [ Time Frame: approximately up to three years ] [ Designated as safety issue: No ]Types of interventions used
- Secondary outcomes to be measured [ Time Frame: approximately up to three years ] [ Designated as safety issue: No ]Perceptions of intervention usefulness. This will be measured by an online survey of the head physician and nurse/office manager and through end of the season site debrief sessions lead by the Co-Investigator and conducted with all clinic staff.
| Estimated Enrollment: | 20300 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Intervention Group Year 1
10 diverse pediatric and family medicine based clinic sites - Intervention sites will use a package of newly developed techniques and evidence-based techniques called the 4 Pillars toolkit along with early season vaccination..
|
Other: 4 Pillars Toolkit for increasing childhood influenza vaccination rates
Pillar 1 Convenient Vaccination Services: Extend Vaccination Season: Use August & September physicals; extend the season beyond January Express Vaccination Services: Influenza vaccination clinics, Open access vaccine scheduling, or Dedicated vaccination station Pillar 2: Patient notification about the importance of vaccination and availability of convenient services Notify when convenient services are available by email, autodialer , "On-hold" messages, social media Pillar 3 Enhanced Office Systems Assessment of influenza vaccination by staff routinely: EMR prompts, review Immunization tab, or check as part of vital signs Empower staff to vaccinate by standing orders programs, per protocol without the need for an individual physician order. Order a sufficient supply Pillar 4: Motivation: Office immunization champion tracks progress towards a goal Set a goal that is a 20% to 25% increase, Monitor and share progress weekly (doses given) Encourage competition |
|
Control Group Year 1 & Intention Group Year 2
10 diverse pediatric and family based clinics - Control sites will not receive assistance with increasing influenza vaccination in Year 1, they will follow guidelines for usual care. In Year 2, they will receive the 4 Pillars Toolkit and early season vaccination
|
|
|
Control Group Year 2
Control group of family medicine and pediatric practices for Year 2
|
Detailed Description:
The investigators will conduct a stratified, randomized cluster trial of 20 diverse practices to compare vaccination rates in intervention and control sites. Intervention sites will use a package of newly developed and evidence-based techniques that will be tailored to their practice structure and culture, called 4 Pillars Toolkit, in addition to early season vaccination. Usual care practices will not receive such assistance.
In the second year, the 10 control practices from the first year will become intervention sites using 4 Pillars toolkit of packaged evidence-based techniques that were used in the intervention sites the previous year, in addition to early season vaccination. A new set of controls will be obtained for Year 2, for comparative purposes.
Eligibility| Ages Eligible for Study: | 6 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Practice staff and children in 20 diverse pediatric and family medicine clinical sites
Inclusion Criteria:
- For health care workers: health care worker at the selected sites - includes all members of the staff at participating practices.
For children: attendance at the selected health care center within the last year and age >/=6 months thru 18 years.
Exclusion Criteria:
- For health care workers: none.
For children: Severe egg allergy or allergy to influenza vaccine
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Richard Zimmerman, MD, MPH | University of Pittsburgh, School of Medicine, Department of Family Medicine and Clinical Epidemiology |
More Information
Additional Information:
No publications provided
| Responsible Party: | Richard Zimmerman, Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01664793 History of Changes |
| Other Study ID Numbers: | 1 U01 IP000321-01 |
| Study First Received: | August 2, 2012 |
| Last Updated: | August 9, 2012 |
| Health Authority: | United States: University of Pittsburgh Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
influenza vaccination strategies children/adolescents |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013