Collaborative Efforts to Increase Flu Vaccination (CollabFlu)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01403649
First received: July 14, 2011
Last updated: January 7, 2013
Last verified: December 2012
  Purpose

Beginning with the 2009-2010 season, influenza vaccine is universally recommended for children age 6 months to 18 years old, placing extra burden on health care providers across the U.S. The focus of this study is to develop new strategies and implement existing evidence-based strategies to enhance influenza immunization in these children. The intervention will involve collaboration from different types of primary care providers, the Colorado Immunization Information System (CIIS), public health departments and visiting nursing services (VNA). It will be designed and implemented by those involved with delivery with a focus on sustainability after the completion of the study. Parental input will be gathered during the planning year through focus groups to assist in developing the intervention. Qualitative assessments and examination of processes during the first year of implementation will guide modifications during the second implementation year in order to assure sustainability. Primary outcome measures in the intervention and control groups: 1) increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 mo.-18 yr. and 2) increase in the rate of children 6 mo.-18 yr. who were fully immunized (received all required influenza injections) during the season. 3) measure outcomes by age group (6 mo.-5 yr., 6-8 yr., 9-12 yr., 13-18 yr.) and types of clinical sites (urban Peds, urban FM, rural FM)


Condition Intervention
Influenza
Collaboration
Behavioral: Private/public collaboration to increase flu vaccination
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Strategies to Vaccinate All Children for Influenza in a Practice Setting

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Evaluate the effectiveness of collaborations between public and private entities to increase influenza vaccination in children 6 mos to 18 yrs in 10 intervention sites in 3 counties throughout the state of CO during the '10-11 & '11-12 flu seasons. [ Time Frame: Up to 4 months post intervention (December 2012) ] [ Designated as safety issue: No ]
    Primary outcome measure is to increase the rate of receipt of ≥1 influenza vaccine during the post-intervention year(s) compared to the pre-intervention year among children 6 mos.-18 yrs in 10 intervention sites. Intervention practices will collaborate with their respective health departments and/or the VNA to help assist with the increase in volume of patients needing to be vaccinated against flu in the 2010-2011 and the 2011-2012 flu seasons. Billing data will be obtained from all 20 sites (intervention+control) and compared to evaluate the effectiveness of this collaboration.


Secondary Outcome Measures:
  • high-risk children receipt of influenza vaccination [ Time Frame: baseline and intervention years 1 and 2 ] [ Designated as safety issue: No ]
    increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among high-risk children

  • high-risk children fully immunized during influenza season [ Time Frame: baseline and intervention years 1 and 2 ] [ Designated as safety issue: No ]
    increase in the rate of high-risk children who were fully immunized during the season.


Estimated Enrollment: 85000
Study Start Date: August 2009
Estimated Study Completion Date: February 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Increasing flu vaccination
Collect from billing records in the 10 intervention practice sites to test for an increase in the rate of receipt of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years during the season. The interventions include: 1. Develop practice-based intervention strategies (like use of reminder-recall of children due for influenza,2. Develop Private/public collaboration to increase flu vaccination between the intervention practices, their county public health department and visiting nursing associations, and 3. Implement both practice-based and private-public collaborative strategies in the intervention practices while monitoring only in the control practices
Behavioral: Private/public collaboration to increase flu vaccination
Intervention practices will develop office-based interventions including methods to identify high-risk patients within their practices and methods of maximizing the immunization of these children within the practice, use of patient reminders, after-hours influenza clinics, walk-in provision of influenza vaccine and increased focus on education regarding the need for immunization. The practices will also collaborate with their county public health departments and visiting nursing associations to develop private-public collaborative interventions that may include large clinics for school-aged children for multiple practices and tracking of influenza supplies and redistribution of influenza vaccine between practices when supplies are delayed or inadequate.
Usual care
Patients in control practices will continue to receive usual care with no change in practice regarding influenza immunization delivery.
Other: Usual care
This group will continue administering influenza vaccine to their patients in their practice as they normally do.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children age 6 mo - 18 yr in up to 20 practices

Exclusion Criteria:

  • Infants under the age of 6 mo or adults over the age of 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403649

Locations
United States, Colorado
Tri County Health dept
Aurora, Colorado, United States, 80010
Aurora Family Medicine
Aurora, Colorado, United States, 80012
Forum Family Medicine
Aurora, Colorado, United States, 80014
Premier Pediatrics
Brighton, Colorado, United States, 80601
Indian Crest Pediatrics
Broomfield, Colorado, United States, 80021
Centennial Pediatrics
Centennial, Colorado, United States, 80014
Advanced Pediatrics
Centennial, Colorado, United States, 80015
Greenwood Pediatrics
Centennial, Colorado, United States, 80112
Pediatrics 5280
Centennial, Colorado, United States, 80112
Pediatric Pathways
Centennial, Colorado, United States, 80112
CIIS
Denver, Colorado, United States, 80246
Hampden Medical Group
Englewood, Colorado, United States, 80113
Family Practice Clinic
Ft. Morgan, Colorado, United States, 80701
Ft. Morgan Medical Group
Ft. Morgan, Colorado, United States, 80701
Haxtun Family Medicine
Haxtun, Colorado, United States, 80731
Valley Medical Center
Julesburg, Colorado, United States, 80737
Kids First
Lakewood, Colorado, United States, 80226
Jefferson County Health dept
Lakewood, Colorado, United States, 80215
Denver West Pediatrics
Lakewood, Colorado, United States, 80401
Focus on Kids
Littleton, Colorado, United States, 80123
Lone Tree Family Medicine
Lone Tree, Colorado, United States, 80124
Crown Point Pediatrics
Parker, Colorado, United States, 80138
Northeast County Health Dept
Sterling, Colorado, United States, 80751
Mountain Land Pediatrics
Thornton, Colorado, United States, 80260
Pediatrics West
Wheat Ridge, Colorado, United States, 80033
Wray Clinic
Wray, Colorado, United States, 80758
Yuma Clinic
Yuma, Colorado, United States, 80759
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Allison Kempe, MD, MPH University of Colorado, Children's Hospital
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01403649     History of Changes
Other Study ID Numbers: 10-0589, 1U01IP000320
Study First Received: July 14, 2011
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

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 August 28, 2014