Adolescent Vaccination in the Medical Home: Established and Innovative Strategies

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01577979
First received: April 12, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Immunization Rates
Behavioral: Text Message Reminder/Recall
Behavioral: Parent Preference

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Adolescent Vaccination in the Medical Home: Established and Innovative Strategies

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percent of adolescents who received ANY needed vaccine or well-care visit


Secondary Outcome Measures:
  • Percent of adolescent patients with 1 or more Tdap vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percent of adolescent patients with 1 or more meningococcal (MCV4) vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percent of adolescent patients with 1 or more HPV vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percent of adolescent patients with 3 or more HPV vaccines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percent of adolescent patients receiving 1 or more influenza vaccine during the preceding influenza season [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percent of adolescent patients with either a documented history of varicella disease or 2 or more varicella vaccines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percent of adolescent patients with 2 or more MMR vaccines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percent of adolescent patients with 3 or more hepatitis B vaccines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percent of adolescent patients with 3 or more poliovirus vaccines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50000
Study Start Date: August 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reminder/Recall Strategy
The experimental group will consist of patients randomly selected from participating clinics. Patients from private practices and the safety net provider may be exposed to a reminder/recall strategy involving text messaging. Text messages will be used to notify parents that their child is due for an immunization or well-care visit. Parents will be able to reply with one of three response options. Patients presenting to the randomly selected experimental managed care clinics for the first HPV vaccination dose will be offered the ability to provide the clinic with their preferred contact method. The preferred method of contact will be used for the second and third HPV dose reminder/recalls.
Behavioral: Text Message Reminder/Recall
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 Name: Text Messaging
Behavioral: Parent Preference
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.
Other Name: Parent Preference
No Intervention: Usual Care
The patients in the usual care group will receive the clinic's usual care in terms of immunization and well-care reminder/recall.

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 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.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577979

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Allison Kempe, MD, MPH University of Colorado Denver, The Children's Hospital of Colorado
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01577979     History of Changes
Other Study ID Numbers: 10-1209, U01IP000310
Study First Received: April 12, 2012
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Vaccination
Medical Home
Adolescents

ClinicalTrials.gov processed this record on April 21, 2014