From Innovation to Solutions: Childhood Influenza Vaccination Planning

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Zimmerman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01664793
First received: August 2, 2012
Last updated: December 10, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The main outcome variable is vaccination rates for each of the sites [ Time Frame: Year 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: 150
Study Start Date: October 2010
Study Completion Date: November 2013
Primary Completion Date: February 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
Study Population

Practice staff and children in 20 diverse pediatric and family medicine clinical sites

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664793

Locations
United States, Pennsylvania
University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Richard Zimmerman, MD, MPH University of Pittsburgh, School of Medicine, Department of Family Medicine and Clinical Epidemiology
Study Director: Chyongchiou Lin, PhD University of Pittsburgh
  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: December 10, 2013
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 April 15, 2014