HPV IIS Reminder/Recall- New York State
Condition: Reminder Systems
Study type: Interventional

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.
    

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. 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#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.

      Hypothesis 2a: IIS-C R/R will result in higher HPV vaccination rates than usual care.

      Hypothesis 2b: IIS-C R/R will result in higher HPV vaccination rates than usual care in key
      subgroups (males and females, younger and older teens, urban//rural teens).

      Hypothesis 2c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care.

      Aim #3: Disseminate IIS-C R/R across NY and CO and pilot in four IISs: (a) Develop an IIS-C
      HPV R/R toolkit, (b) Use a technical advisory group, (c) Initiate IIS-C R/R in four other
      IISs [Yr. 4].

      By the end of the study investigators will have a feasible, sustainable, cost-effective model
      for HPV vaccine reminders that can be used nationally to prevent cervical cancer and other
      HPV-related cancers.
    

Intervention name(s): Vaccine Reminder Recall
Intervention type(s): Other
Intervention description(s): The investigators will be sending recall notices via phone call to 11-17 year olds who are eligible but lacking HPV vaccine doses recorded in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to one of four arms to receive 0,1,2,or 3 reminders for overdue HPV vaccine doses.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: HPV vaccine; Immunization registry; Reminder recall