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Clinical Trials/NCT01577979
NCT01577979
Completed
N/A

Adolescent Vaccination in the Medical Home: Established and Innovative Strategies

University of Colorado, Denver1 site in 1 country34,581 target enrollmentAugust 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Immunization Rate
Sponsor
University of Colorado, Denver
Enrollment
34581
Locations
1
Primary Endpoint
Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

In this project, the investigators will develop, implement, and evaluate an adolescent vaccination quality improvement program, with the program designed to encourage adolescents to visit their usual primary care provider to receive vaccinations and other recommended preventive health services. This study will be conducted in different types of primary care settings, such as public, private, and managed care clinics serving adolescent patients of diverse backgrounds, and will provide important information to help guide future public health efforts to achieve high rates of immunization in adolescents.

Detailed Description

Specific Aim 1: Within different types of primary care practices (pediatric practices in public, private, and managed care settings) serving adolescent patients of diverse socioeconomic and racial/ethnic backgrounds, to assess provider and staff attitudes regarding the desirability, feasibility, and potential sustainability of evidence-based and innovative strategies to promote adolescent vaccination in primary care practices. Specific Aim 2: Among parents of adolescents (and/or adolescent patients) seen at primary care practices, to assess knowledge of existing national and state programs to promote vaccination, and to assess attitudes regarding, perceived barriers to, and acceptability of various practice-based strategies to promote adolescent vaccination. Specific Aim 3: To implement and evaluate the effectiveness of a multi-faceted quality improvement program to promote adolescent vaccination within the medical home. 1. Based upon findings from Specific Aims 1 and 2, develop a quality improvement program containing two or more interventions to promote adolescent vaccination. 2. Select intervention patients to receive a multi-faceted vaccination quality improvement program and usual care patients which will continue receiving usual care. 3. Compare the following primary outcome measure between intervention and usual care patients, overall and stratified by the type of practice setting: 1)percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits 4. Compare the following secondary outcome measures between intervention and usual care patients, overall and stratified by practice setting: 1) percent of adolescent patients with ≥ 1 Tdap vaccine; 2) percent of adolescent patients with ≥ 1 meningococcal (MCV4) vaccine; 3) percent of adolescent patients with ≥ 1 HPV vaccine; 4) percent of adolescent patients with ≥ 3 HPV vaccines; 5) percent of adolescent patients receiving ≥ 1 influenza vaccine during the preceding influenza season; 6) percent of adolescent patients with either a documented history of varicella disease or ≥ 2 varicella vaccines; 7) percent of adolescent patients with ≥ 2 MMR vaccines; 8) percent of adolescent patients with ≥ 3 hepatitis B vaccines; 9) percent of adolescent patients with ≥ 3 poliovirus vaccines; and 10) percent of adolescent patients with ≥ 1 missed vaccination opportunity, defined as having a patient visit to a primary care practice, being eligible for vaccination, and not receiving needed vaccines. Specific Aim 3 (Kaiser Only): Design, implement and evaluate an HPV reminder/recall intervention based on obtaining the parents' and adolescents' preferences for reminder method and recipient at the time of the first dose of HPV. 1. Compare 2nd and 3rd dose HPV vaccination rates among adolescents age 11-17 between intervention and usual care patients. 2. Assess process measures related to feasibility and fidelity of implementation Specific Aim 4: Evaluate the effect of a multi-faceted vaccination quality improvement program on the receipt of non-vaccination clinical preventive services recommended for adolescents. a) Compare the following outcome measures between intervention and usual care patients, overall and stratified by the type of practice setting: 1) receipt of ≥ 1 health maintenance visits within a 12 month interval; 2) receipt of blood pressure screening; and 3) growth assessment, as documented by the measurement of weight and height and calculation of body mass index at a clinic visit. Specific Aim 5: Assess the cost to participating practices of implementing a multi-faceted vaccination quality improvement program designed to promote adolescent vaccination. Specific Aim 6: After conducting a multi-faceted quality improvement program to promote adolescent vaccination, to assess provider and staff attitudes about the program, in particular the perceived benefits of the program and factors which may facilitate or hamper the sustainability of the program within study practices.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 11-17 years old
  • Active patient (visit in last 2 years) of clinics in study
  • Need one or more vaccines or well-care visit

Exclusion Criteria

  • Up to date on vaccines and well-care

Outcomes

Primary Outcomes

Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits

Time Frame: 6 months

Percent of adolescents who received ANY needed vaccine or well-care visit

Secondary Outcomes

  • Percent of adolescent patients with 1 or more Tdap vaccine(6 months)
  • Percent of adolescent patients with 1 or more meningococcal (MCV4) vaccine(6 months)
  • Percent of adolescent patients with 1 or more HPV vaccine(6 months)
  • Percent of adolescent patients with 3 or more HPV vaccines(6 months)
  • Percent of adolescent patients receiving 1 or more influenza vaccine during the preceding influenza season(6 months)
  • Percent of adolescent patients with either a documented history of varicella disease or 2 or more varicella vaccines(6 months)
  • Percent of adolescent patients with 2 or more MMR vaccines(6 months)
  • Percent of adolescent patients with 3 or more hepatitis B vaccines(6 months)
  • Percent of adolescent patients with 3 or more poliovirus vaccines(6 months)
  • Percent of adolescent patients with 1 or more missed vaccination opportunity, defined as having a patient visit to a primary care practice, being eligible for vaccination, and not receiving needed vaccines(6 months)

Study Sites (1)

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