State Immunization Information Systems to Improve HPV Vaccination Rates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 77,716
- Locations
- 1
- Primary Endpoint
- Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)
Study Overview
Brief Summary
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates among adolescents ages 11-17 (with a more focused look at the new two dose series for 11-14 year olds).
Detailed Description
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve HPV vaccination rates among adolescents ages 11-17, and additionally look at the 11-14 year old subset for whom a new 2 dose series has recently been recommended. The investigators will extend previous research on effectiveness of centralized R/R to a new population--adolescents due for HPV vaccine-- and test the use of centralized R/R as a cancer-prevention strategy. Investigators will assess the effect of centralized R/R in two states--one with and one without mandated reporting of vaccinations to IISs, and disseminate IIS R/R to other states. Investigators will implement, evaluate (using the RE-AIM framework 31-36), and disseminate a collaborative, IIS-based centralized HPV vaccine R/R model in which partnerships of public health systems and primary care practices in two states (NY, CO) collaborate to remind parents about HPV vaccination.
Specific Aims and hypotheses:
Aim #1: Adapt IIS messages and delivery systems (e.g., algorithms) previously developed for centralized R/R for other vaccines to fit HPV vaccine IIS R/R.
Aim #2: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) autodialer (phone) R/R in increasing vaccine rates [initial dose (HPV#1) and a complete series (HPV#2 or #3)] among teens.
Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized IIS-based (IIS-C) autodialer (phone) R/R in increasing initiation and completion rates for the HPV vaccine series in adolescents ages 11-17 years. The investigators will use a within-practice design, randomizing patients within randomly selected primary care practices to IIS-C R/R (1, 2, or 3 reminders per dose) compared to usual care (0 reminders from this study). The investigators will apply the RE-AIM framework to evaluate the reach, effectiveness/cost effectiveness, adoption, and implementation of IIS-C R/R.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 11 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •11 through 17 years of age (trial 1)
- •11 through 14 years of age (trial 2)
- •defaulted to our selected clinics within CIIS
- •is either due for an HPV dose at baseline according to Advisory Committee on Immunization Practices (ACIP) guidelines, or
- •has initiated but not yet completed the HPV series at baseline
Exclusion Criteria
- •Has completed the HPV vaccine series according to Advisory Committee on Immunization Practices (ACIP) guidelines
- •Any child whose parents have requested removal from the immunization registry
Arms & Interventions
Control 11-17
No additional intervention done aside from usual care for 11-17 year olds
1 R/R per Dose 11-17
Sending up to one recall notice per dose of HPV vaccine needed for 11-17 year olds
Intervention: Vaccine Reminder/Recall (Other)
2 R/R per Dose 11-17
Sending up to two recall notices per dose of HPV vaccine needed for 11-17 year olds
Intervention: Vaccine Reminder/Recall (Other)
3 R/R per Dose 11-17
Sending up to three recall notices per dose of HPV vaccine needed for 11-17 year olds
Intervention: Vaccine Reminder/Recall (Other)
Control 11-14
No additional intervention done aside from usual care for 11-14 year olds
Phone R/R 11-14
Sending up to two recall notices per dose of HPV vaccine needed via autodialer for 11-14 year olds
Intervention: Vaccine Reminder/Recall (Other)
Mail R/R 11-14
Sending up to two recall notices per dose of HPV vaccine needed via mailed postcards for 11-14 year olds
Intervention: Vaccine Reminder/Recall (Other)
Outcomes
Primary Outcomes
Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)
Time Frame: 5 months
Did those eligible to complete the HPV vaccine series within the time frame of the study do so? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry)
Time Frame: 5 months
Did the adolescent initiate the HPV vaccine series? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
Secondary Outcomes
- Differences between modalities - initiation(5 months)
- Differences between modalities - completion(5 months)
- Differences between arms - initiation(5 months)
- Differences between arms - completion(20 months)