Trial Outcomes & Findings for 4 Pillars Toolkit for Adolescent Vaccination (NCT NCT02165722)
NCT ID: NCT02165722
Last Updated: 2018-08-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline period to post-intervention
Results posted on
2018-08-28
Participant Flow
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.
Unit of analysis: clinics
Participant milestones
| Measure |
Intervention Sites
9 Clinical practices (intervention sites) used the 4 Pillars Toolkit to increase vaccination rates from baseline to end of year 1. Two practices dropped out of the intervention (11-2=9).
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).
The 4 Pillars Toolkit is built around 4 pillars which include evidence-based strategies to increase vaccination rates:
Pillar 1: Convenient Vaccination Services
Pillar 2: Patient Notification
Pillar 3: Enhanced Office Systems
Pillar 4: Motivation
|
Control Sites
11 Clinical Practices \[control sites\] were not actively intervened upon.
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).
|
|---|---|---|
|
Overall Study
STARTED
|
1971 9
|
2202 11
|
|
Overall Study
COMPLETED
|
1971 9
|
2202 11
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
4 Pillars Toolkit for Adolescent Vaccination
Baseline characteristics by cohort
| Measure |
Intervention Sites
n=4 Participants
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).
|
Control Sites
n=5 Participants
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).
|
Total
n=10861 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
percent of participants aged 11-13 years
|
39.9 percent of participants aged 11-13 years
n=5 Participants
|
37.2 percent of participants aged 11-13 years
n=7 Participants
|
38.4 percent of participants aged 11-13 years
n=5 Participants
|
|
Sex/Gender, Customized
percent of female participants
|
49.6 percent of female participants
n=5 Participants
|
51.1 percent of female participants
n=7 Participants
|
50.3 percent of female participants
n=5 Participants
|
|
Race/Ethnicity, Customized
percent of Non-white participants
|
12.0 percent of Non-white participants
n=5 Participants
|
23.4 percent of Non-white participants
n=7 Participants
|
18.2 percent of Non-white participants
n=5 Participants
|
|
Commercial health insurance, %
|
62.2 percent of participants privt insurance
n=5 Participants
|
67.8 percent of participants privt insurance
n=7 Participants
|
64.7 percent of participants privt insurance
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline period to post-interventionPopulation: 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.
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.
Outcome measures
| Measure |
Intervention Group: HPV Series Initiation 11-13 Years of Age
n=1 Participants
Practices: Represents 9 clinical practices
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).
Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.
|
Control Group: HPV Series Initiation 11-13 Years of Age
n=2 Participants
Practices: Represents 11 clinical practices
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).
Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.
|
Intervention Group: HPV Series Initiation 14-17 Years of Age
n=2 Participants
Practices: Represents 9 clinical practices
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).
Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.
|
Control Group: HPV Series Initiation 14-17 Years of Age
n=3 Participants
Practices: Represents 11 clinical practices
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).
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 Initiation Vaccination Rates for Adolescents 11-17 Years of Age
|
13.7 percent change in vaccination rates
|
10.1 percent change in vaccination rates
|
7.8 percent change in vaccination rates
|
5.7 percent change in vaccination rates
|
PRIMARY outcome
Timeframe: Baseline period to post-interventionChange 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.
Outcome measures
| Measure |
Intervention Group: HPV Series Initiation 11-13 Years of Age
n=1 Participants
Practices: Represents 9 clinical practices
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).
Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.
|
Control Group: HPV Series Initiation 11-13 Years of Age
n=2 Participants
Practices: Represents 11 clinical practices
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).
Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.
|
Intervention Group: HPV Series Initiation 14-17 Years of Age
n=2 Participants
Practices: Represents 9 clinical practices
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).
Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.
|
Control Group: HPV Series Initiation 14-17 Years of Age
n=3 Participants
Practices: Represents 11 clinical practices
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).
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
|
14.8 percent change in vaccination rates
|
15.8 percent change in vaccination rates
|
11.6 percent change in vaccination rates
|
10.8 percent change in vaccination rates
|
Adverse Events
Intervention Sites
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Sites
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard K. Zimmerman, MD, MPH, MA
University of Pittsburgh
Phone: 412-383-2354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place