Protocol 1. PROJECT TITLE Maximizing HPV
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Protocol 1. PROJECT TITLE Maximizing HPV vaccination: Real-time Reminders, Guidance, and Recommendations Part 4: Feasibility Trial 2. INVESTIGATOR(S) Principal Investigator: Stephanie A. S. Staras, PhD, MSPH Co-Investigator: Elizabeth Shenkman, PhD Co-Investigator: Lindsay Thompson, MD, MS Co-Investigator: Michael J. Muszynski, MD, FAAP Co-Investigator: William Hogan, MD, MS Co-Investigator: Matt Gurka, PhD 3. ABSTRACT: Human papillomavirus (HPV) vaccines have potential to prevent an average of 26,900 cancer cases each year in the United States, but vaccine coverage rates remain low. We have developed an electronic application, Protect Me 4, to help parents and providers assess and have more productive conversations about needed vaccines. Our long-term goal is to increase HPV vaccination rates among boys and girls within the diverse settings of real-world primary care in the United States. The objective of this protocol is to evaluate the feasibility of Protect Me 4. The central hypothesis is the app will be feasible and show potential for efficacy within real-world clinics. The specific aims of this study are to: (1) evaluate the feasibility of implementing Protect Me 4, and (2) estimate preliminary efficacy of Protect Me 4 to increase HPV vaccine initiation (receipt of first dose). We will perform a group-randomized trial of seven clinics from the OneFlorida Cancer Control Network. The proposed research is significant because the feasibility test will allow us to identify areas for further improvement and demonstrate implementation of Protect Me 4. Upon completion of this protocol, we will be well prepared to submit a competitive proposal (e.g., NIH R01) for a full-scale randomized efficacy trial of Protect Me 4. 4. BACKGROUND: The available human papillomavirus vaccines have potential to prevent up to 17,600 cancer cases among women and 9,300 cancer cases among men each year in the United States. 1 As of 2016, only 65% of girls and 56% of boys aged 13-17 years had received at least one does (i.e., initiated) of the HPV vaccine series. 2 In 2014, the President's Cancer Panel recommended increasing HPV vaccination rates as the number one national priority for cancer prevention.3 Low HPV vaccination rates in the United States are primarily due to missed clinical opportunities (a clinic visit where the patient is eligible for vaccines, but remains unvaccinated). 3-6 Rates of other recommended vaccines for adolescents [tetanus/diphtheria/acellular pertussis (Tdap) vaccine and the meningococcal conjugate (MenACWY) vaccine] are between 22 to 28 percentage point higher than rates for HPV vaccine.2 Indicating that adolescents are going to doctor’s and receiving vaccines, just not the HPV vaccine. Because provider recommendations are the strongest predictor of HPV vaccination (odds ratios range from 3 to 18),6-8 interventions are needed to address provider barriers to recommending the HPV vaccine. Protect Me 4 has been developed using theory- and evidence-based strategies to prime parents for vaccine conversations with providers, remind providers about due vaccines, and inform providers about parent hesitations in real-time. For parents, the Protect Me 4 app will query the Florida state immunization registry and Medicaid and Children’s Health Insurance Program (CHIP) claims databases to retrieve a list of adolescent vaccines that are due for their child. Vaccines included are the four recommended for 11-12 year olds: Tdap, MenACWY, HPV, and seasonal influenza. Protect Me 4 assesses parents’ interest in receiving each due vaccine. For parents who are hesitant to any of the vaccines, the Protect Me 4 app provides tailored responses to common concerns by addressing Health Belief Model concepts.9 For each participating patient, providers will use Protect Me 4 to review due vaccines, any reported parent hesitancy, and tips to address parent-specific vaccine concern. Providers will be able to review this information in real time before meeting with parents. The application has been approved by privacy and IT security (see miscellaneous attachments). 5. SPECIFIC AIMS The study will be conducted at 7 OneFlorida clinics (UF Health- New Berlin, iKids Pediatrics, Halifax Health-Keech Pediatrics, Volusia Pediatrics, UF Health-Blanding, Clermont Pediatrics, and Orlando Health- Baldwin Park). The specific aims of this study are: Aim 1: Evaluate the feasibility of implementing Protect Me 4 in a community clinics. We will randomly assign clinics to use of Protect Me 4. Implementation will be maximized by six theory- and evidence- based quality improvement techniques (i.e., practice facilitation, external and internal provider peer opinion leaders, provider audit and feedback with benchmarking, clinic-wide staff involvement, and provider incentives). To evaluate the feasibility, we will measure reach, adoption, implementation, maintenance, and acceptability. Aim 2: Test vaccination rate data collection strategies and estimate preliminary efficacy of Protect Me 4 to increase HPV vaccine initiation (receipt of first dose). We will collect and compare immunization records between adolescents attending participating clinics during three months prior to the intervention, three months of the supported intervention, and three months of the unsupported intervention. 6. RESEARCH PLAN 6.1 Study Design We will perform a group-randomized trial of six pair-matched clinics (Table 1). The intervention is delivered at the clinic level within three randomly assigned clinics. Control clinics will receive the enhanced Protect Me 4 app following the maintenance period. Three of the intervention clinics were intentionally involved in the development of Protect Me 4 to maximize applicability and effectiveness. To prepare for a larger, efficacy trial where clinics will participate in the intervention without being involved in the development, we selected an additional clinic to participate in the intervention. This fourth intervention clinic, a demonstration clinic, will not be included in the main efficacy analysis, but be evaluated to estimate the typical clinic experience. During the implementation period (months 4-6), intervention clinics will receive the Protect Me 4 app and quality improvement strategies (practice facilitation and external and internal provider peer opinion leaders and provider incentives). During the maintenance period (months 7-9), intervention clinics will receive Protect Me 4 without external support (practice facilitation and external provider peer opinion leaders). For evaluation, vaccination records will be grouped in three-month periods from Medicaid and CHIP claims and Florida Immunization Registry data. 6.2 Study Population Participants will be providers, parents, and 11-to-12-year olds who attend our study clinics during the nine-month study period. We recruited seven clinics in three North and Central Florida metropolitan areas to participate in Protect Me 4. Stratifying by area (Jacksonville, Orlando, Daytona Beach), we randomly assigned one clinic to immediate and one to delayed intervention. The seventh clinic is located in Orlando and is assigned to the intervention. All seven clinics provide vaccinations in house, have providers who participate in Vaccines for Children, and see approximately 300 to 700 adolescents ages 11-to-12-years- old each year. 6.3 Study Recruitment and Enrollment Participants will be recruited from the four intervention clinics. Providers will complete paper consents. Parents will use the iPad to review the consent and provide an electronic consent. Adolescent will also assent on the iPad. 6.3.1. Providers. All providers at the intervention clinics are known associates of the study staff based on their participation in the prior phases of this study. If any new providers begin at the clinics, the clinic peer leaders will introduce them to study staff. Study staff will explain the consent forms and written informed consent will be obtained from providers prior to study inclusion either through in-person one-on-one meetings or with a group meeting. Providers will have an opportunity to ask questions of study staff in semi-private rooms. The consent for providers will include participation in the Provider Participant Survey, the Provider Feedback Survey, the app, and linkage of these data with each other and participation in app-related Maintenance of Certification activities, the percent of their 11- to 12-year-old patients participating in the app, and their HPV vaccination rates. 6.3.2 Parents. Clinic staff will invite all parents of 11- to 12-year-old adolescents visiting the clinic during the recruitment period who are scheduled to see a participating provider to participate. Clinic staff will verify the patient and parent identities following their standard clinic practices for checking in patients for appointments; this will ensure that the participant is the parent or LAR of the adolescent. Once the clinic staff verifies the parent’s identity, the clinic staff enters the first three letters of the child’s last name and date of birth into the app. The system creates a linked PIN. The clinic staff gives the parent the PIN, an informational flyer, and the iPad. To enter the app, the parent enters the child’s first and last name, gender, date of birth, associated PIN, and selects their doctor’s name from the clinic list. For children verified as 11- to 12-years-old, the app presents an electronic consent. After reading the consent, the parent will agree to participate by typing in their name and click on the “Yes, I agree to participate” option (see Parent app survey 1-2-18). Adolescents will assent by clicking on the “Yes, I agree to participate.” Children outside the age range are told they are ineligible and contact information is not retained. If the parent does not consent or the adolescent does not assent, the contact information is discarded. Study staff are not present during the consent process but may be reached by the phone number indicated on the study flyer. Parents will have the option to complete a paper consent. The app will instruct parents to call the study staff number listed on the same screen as the electronic consent.