Clinical trial NCT01577979: Adolescent Vaccination in the Medical Home: Established and Innovative Strategies
Official title: Adolescent Vaccination in the Medical Home: Established and Innovative Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization Rate
Keywords: Vaccination
Medical Home
Adolescents
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2012-04-16
Enrollment: 34581
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits
timeFrame: 6 months
Secondary outcomes:
measure: Percent of adolescent patients with 1 or more Tdap vaccine
timeFrame: 6 months
measure: Percent of adolescent patients with 1 or more meningococcal (MCV4) vaccine
timeFrame: 6 months
measure: Percent of adolescent patients with 1 or more HPV vaccine
timeFrame: 6 months
measure: Percent of adolescent patients with 3 or more HPV vaccines
timeFrame: 6 months
measure: Percent of adolescent patients receiving 1 or more influenza vaccine during the preceding influenza season
timeFrame: 6 months
measure: Percent of adolescent patients with either a documented history of varicella disease or 2 or more varicella vaccines
timeFrame: 6 months
measure: Percent of adolescent patients with 2 or more MMR vaccines
timeFrame: 6 months
measure: Percent of adolescent patients with 3 or more hepatitis B vaccines
timeFrame: 6 months
measure: Percent of adolescent patients with 3 or more poliovirus vaccines
timeFrame: 6 months
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado Denver, The Children's Hospital of Colorado
name: Allison Kempe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kempe A, O'Leary ST, Shoup JA, Stokley S, Lockhart S, Furniss A, Dickinson LM, Barnard J, Daley MF. Parental Choice of Recall Method for HPV Vaccination: A Pragmatic Trial. Pediatrics. 2016 Mar;137(3):e20152857. doi: 10.1542/peds.2015-2857. Epub 2016 Feb 26.
citation: O'Leary ST, Lee M, Lockhart S, Eisert S, Furniss A, Barnard J, Eblovi DE, Shmueli D, Stokley S, Dickinson LM, Kempe A. Effectiveness and Cost of Bidirectional Text Messaging for Adolescent Vaccines and Well Care. Pediatrics. 2015 Nov;136(5):e1220-7. doi: 10.1542/peds.2015-1089. Epub 2015 Oct 5.