Influenza Clinical Trial
— CollabFluOfficial title:
Strategies to Vaccinate All Children for Influenza in a Practice Setting
Verified date | May 2015 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 117175 |
Est. completion date | March 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 18 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Aurora Family Medicine | Aurora | Colorado |
United States | Forum Family Medicine | Aurora | Colorado |
United States | Tri County Health dept | Aurora | Colorado |
United States | Premier Pediatrics | Brighton | Colorado |
United States | Indian Crest Pediatrics | Broomfield | Colorado |
United States | Advanced Pediatrics | Centennial | Colorado |
United States | Centennial Pediatrics | Centennial | Colorado |
United States | Greenwood Pediatrics | Centennial | Colorado |
United States | Pediatric Pathways | Centennial | Colorado |
United States | Pediatrics 5280 | Centennial | Colorado |
United States | CIIS | Denver | Colorado |
United States | Hampden Medical Group | Englewood | Colorado |
United States | Family Practice Clinic | Ft. Morgan | Colorado |
United States | Ft. Morgan Medical Group | Ft. Morgan | Colorado |
United States | Haxtun Family Medicine | Haxtun | Colorado |
United States | Valley Medical Center | Julesburg | Colorado |
United States | Denver West Pediatrics | Lakewood | Colorado |
United States | Jefferson County Health dept | Lakewood | Colorado |
United States | Kids First | Lakewood | Colorado |
United States | Focus on Kids | Littleton | Colorado |
United States | Lone Tree Family Medicine | Lone Tree | Colorado |
United States | Crown Point Pediatrics | Parker | Colorado |
United States | Northeast County Health Dept | Sterling | Colorado |
United States | Mountain Land Pediatrics | Thornton | Colorado |
United States | Pediatrics West | Wheat Ridge | Colorado |
United States | Wray Clinic | Wray | Colorado |
United States | Yuma Clinic | Yuma | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Centers for Disease Control and Prevention |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. | Up to 4 months post intervention (December 2012) | No |
Secondary | high-risk children receipt of influenza vaccination | 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 | baseline and intervention years 1 and 2 | No |
Secondary | high-risk children fully immunized during influenza season | increase in the rate of high-risk children who were fully immunized during the season. | baseline and intervention years 1 and 2 | No |
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