Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

University of Rochester

Status: Enrolling

Conditions: Hpv

Treatments: Behavioral: Standing Orders; Behavioral: Communication

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06380114

R01CA270276 (U.S. NIH Grant/Contract)

STUDY00009296

Details and patient eligibility

About

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.

Enrollment: 16,000 estimated patients

Sex: All

Ages: 9 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• active patient in AHP practice

Exclusion criteria

• patient belonging to a practice with >80% UTD baseline HPV vaccination rate for ages 13-17
• patient belonging to a practice with <20 11-12 year-olds eligible for an HPV dose

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16,000 participants in 2 patient groups

Communication Training

Active Comparator group

Description:

Practice personnel (providers and nurses) receive training in communication about HPV vaccination.

Treatment:

Behavioral: Communication

Communication Training + Standing Orders Training/Implementation

Experimental group

Description:

Practice personnel (providers and nurses) receive training in communication about HPV vaccination and training in the implementation of standing orders for HPV vaccination.

Treatment:

Behavioral: Communication

Behavioral: Standing Orders