Clinical trial NCT03501992: Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination
Official title: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"--Multilevel Interventions for Patient, Parent, and Practice to Enhance Provider Recommendations for HPV Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillomavirus Vaccines
Keywords: Papillomavirus vaccines
Vaccination
Patient acceptance of health care
Child
Parents
Primary health care
Health personnel
Primary prevention
Neoplasms
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-04-18
Enrollment: 9242
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A factorial, stepped-wedge cluster randomized trial with process evaluation
Primary purpose: PREVENTION

Brief summary: Each year the human papillomavirus (HPV) causes 30,000 cancers in the United States despite the availability of very effective and safe vaccines. Uptake of the HPV vaccine has been disappointingly low and lags behind other adolescent vaccines. This study seeks to test interventions targeting health care system, provider, and patient factors to improve the population uptake of the HPV vaccine.

Detailed description: The broad, long-term objective is to substantially increase human papillomavirus (HPV) vaccination rates by deploying effective population-health interventions in clinical practices across the United States. As part of this effort, the investigators intend to evaluate two evidence-based interventions with innovative enhancements at six Mayo Clinic primary care practices (PCP) to evaluate their individual and combined impact on rates of HPV vaccination among female and male patients. Aim 1, "Less Pain, Less Fuss, Right Now!", will test the hypothesis that, as compared to no intervention (current practice), a practice-level intervention utilizing reminder-recalls featuring the availability of non-medication and medication anesthetics, the convenience of nurse-only visits, and the use of persuasive language for early, on-time vaccinations will improve HPV vaccine delivery rates. Aim 2, "Make It Count!", will test the hypothesis that, as compared to no intervention, a provider level intervention utilizing a missed-opportunities assessment and feedback intervention applying social pressure (specific peer-performance comparisons) and equipping providers with a strong-recommendation toolkit will improve HPV vaccine delivery rates. Aim 3 will test the hypothesis that simultaneous implementation of interventions targeting individual, interpersonal, and organizational factors will have a synergistic effect on HPV vaccine delivery rates. To accomplish Aims 1-3, the investigators will use a stepped-wedge cluster randomized trial with an integrated process evaluation. The cluster approach prevents cross-contamination between patients or providers as we allocate two separate interventions (Aims 1 and 2) in the six PCPs. The stepped-wedge design, which ensures all practices eventually receive the same set of interventions, permits the single institutional review board overseeing all six PCPs to approve the study without requiring recruitment and consent of individual patients or providers. The stepped-wedge approach also permits the investigators to test the presence of each of the interventions in each PCP, making trial participation more attractive, while also allowing each practice to serve as its own control, reducing the bias due to imbalanced risk factors across practices. The factorial design allows the investigators to use a single trial to test two interventions and assess each individually and in combination. The design also conserves sample size while maintaining power. The investigators will measure the impact separately in females and males, 11-12 years of age for the rates of receipt of HPV vaccine doses due. Rigorously tested, highly effective, population-level interventions are essential if the US is to reach the Healthy People 2020 goal for HPV vaccination. The rigor, design, and high likelihood of success of this study will provide key evidence regarding practice- and provider-level interventions to improve HPV vaccination rates. Mayo Clinic's best practices inform not only its own 70 practices across five states but its Mayo Clinic Care Network, which consists of nearly 40 health-care organizations across 26 states and Puerto Rico.

Eligibility criteria: Inclusion Criteria:

* Empaneled in one of the six participating primary care practices
* 11 to 12 years of age at the first day of each of the 12-month-long steps
* Due during that 12-month-long step for at least one dose of the HPV vaccine

Exclusion Criteria:

* Not empaneled in one of the six participating practices
* Empaneled in one of the six participating practices but less than 11 years of age or more than 12 years of age on the first day of each 12 month long step
* Not due during that 12-month-long step for a dose of HPV vaccine.

Primary outcomes:
measure: Human Papillomavirus or HPV-vaccine-dose Receipt
timeFrame: The dose had to have been received during the 12-month-long study step.
Secondary outcomes:
measure: Initiation
timeFrame: The initiating dose had to have been received during the 12-month-long study step.
measure: Completion
timeFrame: The final dose had to have been received during the 12-month-long study step.
Other outcomes:
measure: HPV-vaccine-dose Receipt in Females
timeFrame: The dose had to have been received during the 12-month-long study step.
measure: HPV-vaccine-dose Receipt in Males
timeFrame: The dose had to have been received during the 12-month-long study step.
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert M Jacobson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Joan M Griffin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finney Rutten LJ, Griffin JM, St Sauver JL, MacLaughlin K, Austin JD, Jenkins G, Herrin J, Jacobson RM. Multilevel Implementation Strategies for Adolescent Human Papillomavirus Vaccine Uptake: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2024 Jan 1;178(1):29-36. doi: 10.1001/jamapediatrics.2023.4932.
citation: Finney Rutten LJ, Radecki Breitkopf C, St Sauver JL, Croghan IT, Jacobson DJ, Wilson PM, Herrin J, Jacobson RM. Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial. Implement Sci. 2018 Jul 13;13(1):96. doi: 10.1186/s13012-018-0778-x.