Collaborative Efforts to Increase Flu Vaccination

NCT01403649 | Completed

• 2 other identifiers: 10-05891U01IP000320
• Study Type: interventional
• Target: 117,175
• Locations: 1 country
• Sites: 27

Brief 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)

Conditions

Influenza; Collaboration

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• high-risk children receipt of influenza vaccination

  baseline and intervention years 1 and 2

• high-risk children fully immunized during influenza season

  baseline and intervention years 1 and 2

Study Arms (2)

Increasing flu vaccination

EXPERIMENTAL

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

Usual care

OTHER

Patients in control practices will continue to receive usual care with no change in practice regarding influenza immunization delivery.

Other: Usual care

Interventions

Private/public collaboration to increase flu vaccination BEHAVIORAL

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.

Increasing flu vaccination

Usual care OTHER

This group will continue administering influenza vaccine to their patients in their practice as they normally do.

Usual care

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Infants under the age of 6 mo or adults over the age of 18

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (27)

Tri County Health dept

Aurora, Colorado, 80010, United States

Location

Aurora Family Medicine

Aurora, Colorado, 80012, United States

Location

Forum Family Medicine

Aurora, Colorado, 80014, United States

Location

Premier Pediatrics

Brighton, Colorado, 80601, United States

Location

Indian Crest Pediatrics

Broomfield, Colorado, 80021, United States

Location

Centennial Pediatrics

Centennial, Colorado, 80014, United States

Location

Advanced Pediatrics

Centennial, Colorado, 80015, United States

Location

Greenwood Pediatrics

Centennial, Colorado, 80112, United States

Location

Pediatric Pathways

Centennial, Colorado, 80112, United States

Location

Pediatrics 5280

Centennial, Colorado, 80112, United States

Location

CIIS

Denver, Colorado, 80246, United States

Location

Hampden Medical Group

Englewood, Colorado, 80113, United States

Location

Family Practice Clinic

Fort Morgan, Colorado, 80701, United States

Location

Ft. Morgan Medical Group

Fort Morgan, Colorado, 80701, United States

Location

Haxtun Family Medicine

Haxtun, Colorado, 80731, United States

Location

Valley Medical Center

Julesburg, Colorado, 80737, United States

Location

Jefferson County Health dept

Lakewood, Colorado, 80215, United States

Location

Kids First

Lakewood, Colorado, 80226, United States

Location

Denver West Pediatrics

Lakewood, Colorado, 80401, United States

Location

Focus on Kids

Littleton, Colorado, 80123, United States

Location

Lone Tree Family Medicine

Lone Tree, Colorado, 80124, United States

Location

Crown Point Pediatrics

Parker, Colorado, 80138, United States

Location

Northeast County Health Dept

Sterling, Colorado, 80751, United States

Location

Mountain Land Pediatrics

Thornton, Colorado, 80260, United States

Location

Pediatrics West

Wheat Ridge, Colorado, 80033, United States

Location

Wray Clinic

Wray, Colorado, 80758, United States

Location

Yuma Clinic

Yuma, Colorado, 80759, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Patients' Rooms

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Facility Environment; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Allison Kempe, MD, MPH

  University of Colorado, Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 27, 2011
• Study Start: August 1, 2009
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

US (27)