search
Back to results

Collaborative Efforts to Increase Flu Vaccination (CollabFlu)

Primary Purpose

Influenza, Collaboration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Private/public collaboration to increase flu vaccination
Usual care
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tri County Health dept
  • Aurora Family Medicine
  • Forum Family Medicine
  • Premier Pediatrics
  • Indian Crest Pediatrics
  • Centennial Pediatrics
  • Advanced Pediatrics
  • Greenwood Pediatrics
  • Pediatric Pathways
  • Pediatrics 5280
  • CIIS
  • Hampden Medical Group
  • Family Practice Clinic
  • Ft. Morgan Medical Group
  • Haxtun Family Medicine
  • Valley Medical Center
  • Jefferson County Health dept
  • Kids First
  • Denver West Pediatrics
  • Focus on Kids
  • Lone Tree Family Medicine
  • Crown Point Pediatrics
  • Northeast County Health Dept
  • Mountain Land Pediatrics
  • Pediatrics West
  • Wray Clinic
  • Yuma Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Increasing flu vaccination

Usual care

Arm Description

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

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

Outcomes

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.
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
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
increase in the rate of high-risk children who were fully immunized during the season.

Full Information

First Posted
July 14, 2011
Last Updated
May 29, 2015
Sponsor
University of Colorado, Denver
Collaborators
Centers for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT01403649
Brief Title
Collaborative Efforts to Increase Flu Vaccination
Acronym
CollabFlu
Official Title
Strategies to Vaccinate All Children for Influenza in a Practice Setting
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)
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 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. 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Collaboration

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Increasing flu vaccination
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
Other
Arm Description
Patients in control practices will continue to receive usual care with no change in practice regarding influenza immunization delivery.
Intervention Type
Behavioral
Intervention Name(s)
Private/public collaboration to increase flu vaccination
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
This group will continue administering influenza vaccine to their patients in their practice as they normally do.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Up to 4 months post intervention (December 2012)
Secondary Outcome Measure Information:
Title
high-risk children receipt of influenza vaccination
Description
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
Time Frame
baseline and intervention years 1 and 2
Title
high-risk children fully immunized during influenza season
Description
increase in the rate of high-risk children who were fully immunized during the season.
Time Frame
baseline and intervention years 1 and 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Kempe, MD, MPH
Organizational Affiliation
University of Colorado, Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri County Health dept
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Aurora Family Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Forum Family Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Premier Pediatrics
City
Brighton
State/Province
Colorado
ZIP/Postal Code
80601
Country
United States
Facility Name
Indian Crest Pediatrics
City
Broomfield
State/Province
Colorado
ZIP/Postal Code
80021
Country
United States
Facility Name
Centennial Pediatrics
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Advanced Pediatrics
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80015
Country
United States
Facility Name
Greenwood Pediatrics
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Pediatric Pathways
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Pediatrics 5280
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
CIIS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Hampden Medical Group
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Family Practice Clinic
City
Ft. Morgan
State/Province
Colorado
ZIP/Postal Code
80701
Country
United States
Facility Name
Ft. Morgan Medical Group
City
Ft. Morgan
State/Province
Colorado
ZIP/Postal Code
80701
Country
United States
Facility Name
Haxtun Family Medicine
City
Haxtun
State/Province
Colorado
ZIP/Postal Code
80731
Country
United States
Facility Name
Valley Medical Center
City
Julesburg
State/Province
Colorado
ZIP/Postal Code
80737
Country
United States
Facility Name
Jefferson County Health dept
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Kids First
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80226
Country
United States
Facility Name
Denver West Pediatrics
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Focus on Kids
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80123
Country
United States
Facility Name
Lone Tree Family Medicine
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Crown Point Pediatrics
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Northeast County Health Dept
City
Sterling
State/Province
Colorado
ZIP/Postal Code
80751
Country
United States
Facility Name
Mountain Land Pediatrics
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Facility Name
Pediatrics West
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Wray Clinic
City
Wray
State/Province
Colorado
ZIP/Postal Code
80758
Country
United States
Facility Name
Yuma Clinic
City
Yuma
State/Province
Colorado
ZIP/Postal Code
80759
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Collaborative Efforts to Increase Flu Vaccination

We'll reach out to this number within 24 hrs