ClinicalTrials.Veeva

Menu

Adolescent Vaccination in the Medical Home: Established and Innovative Strategies

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Immunization Rate

Treatments

Behavioral: Text Message Reminder/Recall
Behavioral: Parent Preference

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01577979
10-1209
U01IP000310 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

34,581 patients

Sex

All

Ages

11 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

34,581 participants in 2 patient groups

Reminder/Recall Strategy
Experimental group
Description:
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.
Treatment:
Behavioral: Parent Preference
Behavioral: Text Message Reminder/Recall
Usual Care
No Intervention group
Description:
The patients in the usual care group will receive the clinic's usual care in terms of immunization and well-care reminder/recall.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems