4 Pillars Toolkit for Adolescent Vaccination
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|ClinicalTrials.gov Identifier: NCT02165722|
Recruitment Status : Completed
First Posted : June 17, 2014
Results First Posted : July 30, 2018
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adolescent HPV Vaccine Adolescent Influenza Vaccine||Behavioral: 4 Pillars Toolkit||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Enhanced 4 Pillars Toolkit for Increasing Adolescent Immunization: A Randomized Controlled Cluster Trial in Pediatrics and Family Medicine|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Intervention: Toolkit
4 Pillars Toolkit
Behavioral: 4 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).
No Intervention: No Intervention: Standard practice
11 Clinical Practices [control sites]
- Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165722
|United States, Pennsylvania|
|University of Pittsburgh, School of Medicine, Department of Family Medicine|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Richard K Zimmerman, MD, MPH, MA||University of Pittsburgh|