Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 17
Healthy Volunteers: t
View:

• active patient in AHP practice

Locations
United States
New York
University of Rochester Medical Center (URMC)
RECRUITING
Rochester
Contact Information
Primary
Robin Bender
robin_bender@urmc.rochester.edu
(585) 274-1499
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2027-11
Participants
Target number of participants: 16000
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Leads: University of Rochester

This content was sourced from clinicaltrials.gov