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OpenTrials
Completed

NCT Number: NCT01577979

Adolescent Vaccination in the Medical Home: Established and Innovative Strategies

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.

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Key information

Conditions

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

  • Based upon findings from Specific Aims 1 and 2, develop a quality improvement program containing two or more interventions to promote adolescent vaccination.
  • Select intervention patients to receive a multi-faceted vaccination quality improvement program and usual care patients which will continue receiving usual care.
  • 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
  • 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.

  • Compare 2nd and 3rd dose HPV vaccination rates among adolescents age 11-17 between intervention and usual care patients.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text Message Reminder/Recall

Behavioral

Adolescents will be randomly selected from the participating private practices and safety net organization clinics. Parents of selected adolescents will receive a text message to alert them that their child is due for a vaccine or well-care visit. The text message will provide response instructions. The responses can be one of three options: 1) the parent will call the clinic to schedule a visit, 2) the parent would like the clinic to call them to schedule a visit, or 3) the parent would like to stop any future text message reminders. Parents who would like the clinic to call them to schedule an appointment will be contacted by their child's provider to set up a visit. Parents may receive up to 3 text message reminders, unless they chose to stop any future messages.

Other names: Text Messaging

Parent Preference

Behavioral

Parents of adolescents being seen within the managed care organization's intervention clinics will be asked about their reminder method preference at their child's 1st HPV immunization. The preference options include phone call, text message, or email. The preference for contact method will be recorded and utilized for the 2nd and 3rd dose reminders. The clinics' usual method of reminder will be used for all other parents.

Primary outcomes

  1. 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

  1. Percent of adolescent patients with 1 or more Tdap vaccine

    Time frame: 6 months

  2. Percent of adolescent patients with 1 or more meningococcal (MCV4) vaccine

    Time frame: 6 months

  3. Percent of adolescent patients with 1 or more HPV vaccine

    Time frame: 6 months

  4. Percent of adolescent patients with 3 or more HPV vaccines

    Time frame: 6 months

  5. Percent of adolescent patients receiving 1 or more influenza vaccine during the preceding influenza season

    Time frame: 6 months

  6. Percent of adolescent patients with either a documented history of varicella disease or 2 or more varicella vaccines

    Time frame: 6 months

  7. Percent of adolescent patients with 2 or more MMR vaccines

    Time frame: 6 months

  8. Percent of adolescent patients with 3 or more hepatitis B vaccines

    Time frame: 6 months

  9. Percent of adolescent patients with 3 or more poliovirus vaccines

    Time frame: 6 months

  10. 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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 16, 2012
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.