Adolescent HPV Vaccine, Adolescent Influenza Vaccine
Conditions
Keywords
Influenza, HPV, Tdap, MCV, vaccination, adolescents
Brief summary
The purpose of this study is to test whether or not the 4 Pillars Immunization Toolkit increases adolescent vaccination rates, particularly influenza and human papillomavirus (HPV) but also tetanus, diphtheria and pertussis (Tdap), and meningococcal conjugate (MCV) vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to national guidelines. The investigators will conduct a randomized cluster trial of this toolkit in diverse primary care practices with electronic medical records (EMRs).
Detailed description
This intervention is a stratified randomized cluster trial in about 22 diverse primary care practices. These practices will be randomly assigned to be intervention or control sites to test this 4 Pillars Immunization Toolkit intervention package of evidence-based techniques tailored to their practice structure and culture; the specialties are split between pediatric and family medicine practices. .
Interventions
BEHAVIORAL4 Pillars Toolkit
Behavioral: Pillar 1: Convenient Vaccination Services (e.g. use every visit \[chronic and acute\] as an opportunity to vaccinate; use express vaccination clinics and dedicated vaccination stations; use influenza vaccination as an opportunity to vaccinate for other vaccines). Behavioral: Pillar 2: Patient Notification (e.g. use electronic reminders and social media for vaccination reminders; use physician recommendations). Behavioral: Pillar 3: Enhanced Office Systems (e.g. implement Standing Order Programs; use EMR prompts; add vaccination status as a vital sign when rooming). Behavioral: Pillar 4: Motivation (e.g. establish an office Immunization Champion to track goal progress, aided by research team feedback).
Sponsors
Pfizer
Merck Sharp & Dohme LLC
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* For clinical sites: inclusion criterion includes 1. an appropriate adolescent population: e.g., adolescents aged 11 to 17 years 2. currently using an EMR 3. having and keeping immunization data within a EMR or registry.
Exclusion criteria
* For clinical sites: the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age | Baseline period to post-intervention | Change in cumulative vaccination rates from baseline to end of year 1 for HPV series initiation (e.g., receipt of first dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015. |
| Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age | Baseline period to post-intervention | Change in cumulative vaccination rates from baseline to end of year 1 for HPV series completion (e.g., receipt of third dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015. |
Countries
United States
Participant flow
Recruitment details
Cluster randomized trial where units reflect clinical practices enrolled. Numbers of participants who started and ended study reflect the longitudinal analytic data set of patients who had a visit during both the baseline and intervention periods.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Sites Clinical practices: 9 Clinical practices (intervention sites) used the 4 Pillars Toolkit to increase vaccination rates from baseline to end of year 1.
Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). | 4 |
| Control Sites Clinical practices: 11 Clinical Practices \[control sites\] were not actively intervened upon but continued their standard clinical practices regarding provision of vaccinations.
Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). | 5 |
| Total | 9 |
Baseline characteristics
| Characteristic | Intervention Sites | Control Sites | Total |
|---|---|---|---|
| Age, Customized percent of participants aged 11-13 years | 39.9 percent of participants aged 11-13 years | 37.2 percent of participants aged 11-13 years | 38.4 percent of participants aged 11-13 years |
| Commercial health insurance, % | 62.2 percent of participants privt insurance | 67.8 percent of participants privt insurance | 64.7 percent of participants privt insurance |
| Race/Ethnicity, Customized percent of Non-white participants | 12.0 percent of Non-white participants | 23.4 percent of Non-white participants | 18.2 percent of Non-white participants |
| Sex/Gender, Customized percent of female participants | 49.6 percent of female participants | 51.1 percent of female participants | 50.3 percent of female participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4,942 | 0 / 5,919 |
| serious Total, serious adverse events | 0 / 4,942 | 0 / 5,919 |
Outcome results
Primary
Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age
Change in cumulative vaccination rates from baseline to end of year 1 for HPV series completion (e.g., receipt of third dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.
Time frame: Baseline period to post-intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group: HPV Series Initiation 11-13 Years of Age | Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age | 14.8 percent change in vaccination rates |
| Control Group: HPV Series Initiation 11-13 Years of Age | Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age | 15.8 percent change in vaccination rates |
| Intervention Group: HPV Series Initiation 14-17 Years of Age | Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age | 11.6 percent change in vaccination rates |
| Control Group: HPV Series Initiation 14-17 Years of Age | Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age | 10.8 percent change in vaccination rates |
p-value: 0.001Chi-squared
p-value: >0.05Chi-squared
p-value: >0.05Chi-squared
p-value: >0.05Chi-squared
Primary
Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age
Change in cumulative vaccination rates from baseline to end of year 1 for HPV series initiation (e.g., receipt of first dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.
Time frame: Baseline period to post-intervention
Population: HPV series initiation stratified by age of 11-13 years and 14-17 years of age. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group: HPV Series Initiation 11-13 Years of Age | Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age | 13.7 percent change in vaccination rates |
| Control Group: HPV Series Initiation 11-13 Years of Age | Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age | 10.1 percent change in vaccination rates |
| Intervention Group: HPV Series Initiation 14-17 Years of Age | Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age | 7.8 percent change in vaccination rates |
| Control Group: HPV Series Initiation 14-17 Years of Age | Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age | 5.7 percent change in vaccination rates |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
Comparison: Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.p-value: <0.001Chi-squared
p-value: <0.001Chi-squared