Fiks AG, Grundmeier RW, Mayne S, Song L, Feemster K, Karavite D, Hughes CC, Massey J, Keren R, Bell LM, Wasserman R, Localio AR. (2013). Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. Pediatrics, 131 , 1114-1124.
Designed to increase HPV vaccination among girls, this decision-support intervention has two parts: (1) a clinician-focused component, which includes alerts through the electronic health record system that a patient is due for a vaccine, a video presentation on adolescent vaccine safety and strategies to overcome barriers, and quarterly reports on immunization rates, and (2) a family-based component, which involves automated vaccine reminder telephone calls.
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In the United States, approximately 79 million people are currently infected with human papillomaviruses (HPVs), a group of more than 200 related viruses. HPV is the most common sexually transmitted infection in the United States, with the majority of sexually active men and women getting a form of HPV in their lifetime. Although some sexually transmitted HPVs do not cause cancer but can cause skin warts on or around the genitals or anus, others can cause cancer. HPVs are responsible for the majority of cervical, anal, oropharyngeal, and vaginal cancers, as well as half of vulvar cancers and about a third of penile cancers.
Vaccines are available to help prevent the spread of the types of HPV known to cause cancer. The Centers for Disease Control and Prevention recommends that children aged 11 or 12 years receive two doses of the HPV vaccine, given at least 6 months apart. Three doses are recommended for those who receive their first two doses less than 5 months apart. Across the United States, only 6 out of 10 girls aged 13-17 years have received at least one dose of the HPV vaccine series. Interventions are needed to increase HPV vaccination among adolescent girls and thus reduce the incidence of HPV infection and the risks of cervical and other cancers caused by HPV.
Give Teens Vaccines is a decision support intervention designed to increase HPV vaccination rates among girls aged 11 to 17 years through the use of education and automated tools. The intervention has both clinician-focused and family-focused components delivered within pediatric practices:
-- The clinician-focused component consists of three elements to encourage clinicians to recommend HPV vaccination to their patients. First, alerts for routine adolescent vaccinations are programmed into the electronic health record (EHR) system so clinicians see them during all patient encounters. Second, clinicians receive a 1-hour video presentation that provides information on adolescent vaccine safety and efficacy and strategies to overcome barriers to vaccination. The presentation is intended to help clinicians feel more comfortable discussing adolescent vaccines, particularly for HPV, with families. (The presentation is currently provided on video but was given in person or online as a PowerPoint presentation in the study that was reviewed). Clinicians also receive aggregated and EHR-based, site-specific data about HPV vaccination rates. Third, clinicians receive quarterly performance feedback reports during implementation that show rates of captured immunization opportunities at the individual clinician, practice, and network level based on EHR data.
-- The family-focused component consists of three different types of automated telephone calls based on an EHR-generated roster: For patients who have a scheduled well-visit appointment and are due for an HPV vaccine, parents receive a reminder call 2 business days before the appointment; for patients who have not had a well visit within the past 10 months, do not have one scheduled, and are due for an HPV vaccine, parents receive up to two reminder calls to schedule an appointment; and for patients due for dose 2 or 3 of the vaccine, parents receive a reminder call to schedule an appointment with a second reminder call 1 month later, if needed. The automated messages state that the vaccine is due, emphasize that the vaccine is recommended by the adolescent's clinician, and refer families to a website that links to educational materials on adolescent vaccinations.
Community Preventive Services Task Force Finding
-- Approximately 10 hours to program clinician alerts into an existing EHR system
-- 1 hour for clinicians to watch a presentation on the intervention, HPV, and the vaccination
-- 1 hour for a research assistant to generate each quarterly performance feedback report from EHR data
-- Approximately 40 hours for a programmer to set up automated telephone calls to patients
Give Teens Vaccines targets girls aged 11 to 17 years.
This intervention can be implemented in pediatric practices in urban, rural, and suburban communities.
Required resources to implement the program include the following:
-- Give Teens Vaccines Study Implementation Guide
-- Automated Reminder Call Scripts
-- EHR Alert Screenshot
-- Feedback Reports
-- HPV Education Video
For costs associated with this program, please contact the developer, Alexander Fiks. (See products page on the RTIPs website for developer contact information.)
About the Study
A cluster-randomized controlled trial with a nested design compared the benefits of a clinician- and/or family-focused intervention on HPV vaccination. The study, conducted within the Children's Hospital of Philadelphia (CHOP) Pediatric Research Consortium (PeRC) in 2010, used four intervention groups: a group receiving clinician- and family-focused intervention combined, one receiving clinician-focused intervention only, one receiving family-focused intervention only, and a control group. Randomization occurred at the site level and patient level. First, 22 sites were stratified into urban resident teaching versus other practices, sorted by rate of HPV dose 1 vaccination, and allocated to the clinician-focused intervention (11) or no clinician-focused intervention (11). Patient-level randomization was nested within this design; within the clinician-focused intervention and no clinician-focused intervention groups, participants were assigned to the family-focused intervention or no family-focused intervention. Following this design, researchers assigned 5,606 participants to the combined intervention, 5,593 to the clinician-only intervention, 5,714 to the family-only intervention, and 5,720 to the control.
Participants were girls aged 11 to 17 years who were due for dose 1, 2, or 3 of the HPV vaccine during the 12-month study period and had a preventive visit within 15 months of randomization. The participants were white, non-Hispanic (55%), African American, non-Hispanic (31%), Asian, non-Hispanic (2%), and other (12%). About two-thirds of participants were aged 11‒13 (69%), with the remainder being aged 14‒17. Most participants (79%) had not received any doses of the HPV vaccine at the time of randomization.
The main outcome―HPV vaccination rates―was assessed through review of electronic health records during the 12-month study period. Vaccination rates for each of the four intervention arms were calculated and compared at dose 1, dose 2, and dose 3. The percentage vaccinated was the number of patients who were vaccinated relative to the patients who were due to be vaccinated (e.g., the calculation for dose 2 only included patients who had already received dose 1 and were due for dose 2).
- During the 12-month study period, significantly higher vaccination rates were found in the combined intervention group compared with the control group at dose 1 (p=.001) and dose 3 (p<.001), in the clinician-only group compared with the control group at dose 1 (p=.003), in the family-only group compared with the control group at dose 3 (p<.001), in the combined intervention group compared with the clinician-only group at dose 2 (p<.001) and dose 3 (p<.001), and in the combined intervention group compared with the family-only group at dose 1 (p=.001).