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Collaborative Efforts to Increase Flu Vaccination

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza; Collaboration

Intervention: Private/public collaboration to increase flu vaccination (Behavioral); Usual care (Other)

Phase: N/A

Status: Completed

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Allison Kempe, MD, MPH, Principal Investigator, Affiliation: University of Colorado, Children's Hospital

Summary

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)

Clinical Details

Official title: Strategies to Vaccinate All Children for Influenza in a Practice Setting

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: 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.

Secondary outcome:

high-risk children receipt of influenza vaccination

high-risk children fully immunized during influenza season

Detailed description: Specific Aim 1: Within each of three types of clinical sites (urban pediatric, urban family medicine, and rural family medicine) recruit a group of similar practices (Year 1) 1a. Randomize practices within each type of clinical site to either the intervention or the control group 1b. Establish private-public collaborations for influenza vaccination delivery between county public health departments, visiting nursing associations and each of the intervention practices within the three clinical site types Specific Aim 2: Conduct focus groups among parents of children seen at intervention practices, to assess attitudes and perceived barriers to possible practice-based and collaborative strategies to promote influenza vaccination (Year 1) Specific Aim 3: Develop (Year 1) and implement (Years 2 and 3) a plan for comprehensive and collaborative delivery of influenza vaccine at intervention practices 3a. Develop practice-based intervention strategies focusing primarily on immunization of high-risk patients 3b. Develop private-public collaborative interventions between the intervention practices, their county public health department and visiting nursing associations focusing primarily on immunization of school-aged children 3c. Implement (Years 2 and 3) both practice-based and private-public collaborative strategies in the intervention practices while monitoring only in the control practices Specific Aim 4: Conduct a group-randomized trial to evaluate and compare the effectiveness of the comprehensive delivery model in improving influenza vaccination coverage for children 6 months to 18 years in three different types of clinical sites (urban pediatric, urban family medicine, and rural family medicine). 4a. Evaluate effectiveness of the comprehensive delivery model at each of the three types of clinical sites 1. Compare the following 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 months to 18 years and 2) increase in the rate of children 6 months to 18 years who were fully immunized (received all required influenza injections) during the season. 2. Compare the following secondary outcome measures: 1) 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 and 2) increase in the rate of high-risk children who were fully immunized during the season. 3. Evaluate sustainability of the comprehensive delivery model on the above outcome measures 4b. Compare the effectiveness of the comprehensive delivery model in three different types of clinical sites (urban pediatric private practice, urban family medicine private practice, and rural family medicine private practice) Specific Aim 5: Evaluate the process of implementation of the comprehensive delivery model for influenza delivery in each of the three types of sites. 5a. Assess process measures relevant to implementation of practice-based interventions and compare by type of clinical site 5b. Assess process measures relevant to implementation of private-public collaborative interventions and compare by type of clinical site 5c. Using key informant interviews, assess perceptions regarding facilitators and barriers to private-public collaborative delivery, alternative methods and means of improving the process among practice providers, administrators and among participating public health and visiting nurse personnel Specific Aim 6: In two urban pediatric intervention practices and one rural family medicine practice, conduct surveys examining parental attitudes about methods of influenza delivery and their experience with their practice's participation in a comprehensive and collaborative private-public model for influenza delivery Major Hypotheses: SA4. Hypothesis 1. Effectiveness on receipt of ≥1 influenza vaccine: The increase in the likelihood of receiving ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years will be greater for children in intervention practices than in control practices.

SA4. Hypothesis 2 Effectiveness - fully immunized: The increase in the likelihood of

receiving all necessary influenza vaccines during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years will be greater for children in intervention practices than in control practices. SA4. Hypothesis 3. Effectiveness by age strata: The increase in the likelihood of receiving ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children in each of the following age strata will be greater in intervention than in control practices: 1) 6 months through 5 years; 2) 6 through 8 years; 3) 9 through 12 years; 4) 13 through 18 years. SA4. Hypothesis 4. Effectiveness in high-risk children: The increase in the likelihood of receiving of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among high-risk children 6 months to 18 years will be greater for high-risk children in intervention practices than in control practices. SA4. Hypothesis 5. Sustainability: The increase in the likelihood of receiving ≥1 influenza vaccine during the second post-intervention year compared to the pre-intervention year among children 6 months to 18 years will be greater for children in intervention practices than in control practices. (Sustainability will also be evaluated for other outcomes above.) SA4. Hypothesis 6. Differential effectiveness by clinical site type: The increase in the likelihood of receiving of ≥1 influenza vaccine during the post-intervention year compared to the pre-intervention year among children 6 months to 18 years for intervention vs. controls will differ by clinical site type

Eligibility

Minimum age: 6 Months. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

Aurora Family Medicine, Aurora, Colorado 80012, United States

Forum Family Medicine, Aurora, Colorado 80014, United States

Tri County Health dept, Aurora, Colorado 80010, United States

Premier Pediatrics, Brighton, Colorado 80601, United States

Indian Crest Pediatrics, Broomfield, Colorado 80021, United States

Advanced Pediatrics, Centennial, Colorado 80015, United States

Centennial Pediatrics, Centennial, Colorado 80014, United States

Greenwood Pediatrics, Centennial, Colorado 80112, United States

Pediatric Pathways, Centennial, Colorado 80112, United States

Pediatrics 5280, Centennial, Colorado 80112, United States

CIIS, Denver, Colorado 80246, United States

Hampden Medical Group, Englewood, Colorado 80113, United States

Family Practice Clinic, Ft. Morgan, Colorado 80701, United States

Ft. Morgan Medical Group, Ft. Morgan, Colorado 80701, United States

Haxtun Family Medicine, Haxtun, Colorado 80731, United States

Valley Medical Center, Julesburg, Colorado 80737, United States

Denver West Pediatrics, Lakewood, Colorado 80401, United States

Jefferson County Health dept, Lakewood, Colorado 80215, United States

Kids First, Lakewood, Colorado 80226, United States

Focus on Kids, Littleton, Colorado 80123, United States

Lone Tree Family Medicine, Lone Tree, Colorado 80124, United States

Crown Point Pediatrics, Parker, Colorado 80138, United States

Northeast County Health Dept, Sterling, Colorado 80751, United States

Mountain Land Pediatrics, Thornton, Colorado 80260, United States

Pediatrics West, Wheat Ridge, Colorado 80033, United States

Wray Clinic, Wray, Colorado 80758, United States

Yuma Clinic, Yuma, Colorado 80759, United States

Additional Information

Starting date: August 2009
Last updated: May 29, 2015

Page last updated: August 20, 2015

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