Provider Recommendation and HPV Vaccination

Part of paid clinical trials in Pasadena, California.

Sponsor
Kaiser Permanente
Study ID
NCT05365048
Status
Recruiting
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Conditions

  • Human Papillomavirus

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Local Tailoring implementation strategy — OTHER
    The "local-tailored" approach will be guided by a structured process involving the following: (1) convening a local HPV vaccine project team, (2) conducting a local diagnostic process to identify top barriers, (3) selecting from a menu of intervention options that will be offered in this study, categorized by core function (i.e., the forms and functions menu) that address top local barriers, and (4) deploying the selected interventions. The barrier assessment and intervention customization are key processes for the local-tailored strategy, which allow clinics to devote resources to respond to unique local barriers in addition to common barriers.
  • Prescribed Strategy — OTHER
    The prescribed strategy is the standard implementation approach used by most health systems. Our prescribed approach will be guided by the evidence-based, award-winning 4 Pillars™ Practice Transformation Program for improving vaccination rates in the outpatient setting. The 4 Pillars™ address 4 main "functions", i.e., convenience, communication, office systems, and motivation to guide the selection of interventions. For adolescent HPV vaccination, the 4 Pillars has demonstrated moderate effectiveness.

Study Details

In the United State, there are millions of US teens who are not vaccinated against the human papillomavirus (HPV) putting them at risk of getting HPV-related cancers. Although there are clinical guidelines recommending the HPV vaccine and interventions encouraging parents to vaccinate their children to prevent HPV-related cancers, the vaccination rate for teens remains low according to a 2018 national survey. Survey data shows that HPV vaccine complete series coverage for teens aged 13-15 years was 50%, far below the 80% target of Healthy People 2020. Receiving a strong provider recommendation is the most powerful strategy for improving HPV vaccine rates. Yet, little is known about how to include provider recommendations and other important factors into an intervention to improve the HPV vaccination rates. Studies show there are provider, patient and system-level barriers in the initiation and completion of HPV vaccine series among 9-12 years old children. Barriers to the HPV vaccine also differ across demographic subgroups, communities, and clinics. Interventions that address only one component are not responsive to site barriers and as effective as one that addresses multiple components and site-specific barriers. This study uses a 3-arm cluster randomized controlled trial (RCT) to compare three implementation strategies to improve provider recommendations on the HPV vaccine. Two of the implementation strategies (local-tailored and prescribed strategy) utilize a multilevel approach. The three implementation strategies of interest are (1) a "local-tailored" implementation strategy, co-designed with local care teams to address local barriers and contexts (2) A "prescribed" strategy, most commonly used by health systems, that involves pre-specified interventions addressing pre-selected vaccination barriers and (3) usual standard of care where there are no research-led activities. We will use surveys, interviews, and electronic health records to evaluate the three implementation strategies and their impact on improving HPV vaccination rates. The study surveys and interviews will include pediatric providers, nurses, administrators, staff members, and parents of HPV vaccine-eligible children (9-12 years old). Successful implementation will be defined as improvement in HPV vaccination rates (primary outcome), strengthening provider recommendation (secondary outcome), and the cost-effectiveness of the implementation strategy.

Key Dates

Start date
Mar 21, 2022
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
301,201 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Local Tailoring
    The intervention arm will include 20 clinics randomly assigned to the intervention arm. All physicians, nurses, department administrator and other staff members from the pediatric departments randomized to this arm will be included in the study, as well as parents of HPV vaccine eligible children (9-12 years old) who had one or more visits with their pediatric provider during the data collection period.
  • Experimental: Prescribed Strategy
    The intervention arm will include 20 clinics randomly assigned to the intervention arm.. All physicians, nurses, department administrator,s and other staff members from the pediatric departments randomized to this arm will be included in the study, as well as parents of HPV vaccine eligible children (9-12 years old) who had one or more visits with their pediatric provider during the data collection period.
  • No Intervention: Usual Care
    The intervention arm will include 20 clinics randomly assigned to the usual care arm. All physicians, nurses, department administrators,s and other staff members from the pediatric departments randomized to this arm will be included in the study, as well as parents of HPV vaccine eligible children (9-12 years old) who had one or more visits with their pediatric provider during the data collection period.

Primary Outcome Measure

Proportion of children 9-12 years old who received the first dose of the HPV vaccine -EMR [ Time Frame: Year 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Southern CaliforniaPasadenaCalifornia91101
Nancy Takahashi Cannizzaro, PhD
[email protected]
626-564-7663
Chunyi Hsu, MPH
[email protected]
626-564-3508

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