Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06380114
Status
Recruiting
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Conditions

  • Hpv

Eligibility Criteria

Sex
ALL
Age
9 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Communication — BEHAVIORAL
    Practice personnel (providers and nurses) receive training in communication about HPV vaccination via an online learning module.
  • Standing Orders — BEHAVIORAL
    Practice personnel (providers and nurses) receive training in the implementation of standing orders for HPV vaccination via an online learning module and meetings with the study team.

Study Details

Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time. Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 9-17 year-olds.

Key Dates

Start date
Nov 4, 2024
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
16,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Communication Training
    Practice personnel (providers and nurses) receive training in communication about HPV vaccination.
  • Experimental: Communication Training + Standing Orders Training/Implementation
    Practice personnel (providers and nurses) receive training in communication about HPV vaccination and training in the implementation of standing orders for HPV vaccination.

Primary Outcome Measure

Patient-Level Captured Opportunities for HPV Vaccination [ Time Frame: 12-month intervention period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical Center (URMC)RochesterNew York14642
Robin Bender, LMSW

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University of Rochester Medical Center (URMC)· Rochester, NY

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