Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

Hpv Clinical Trial

Official title:

Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380114
• Other study ID #: STUDY00009296
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: November 2027

Study information

• Verified date: May 2024
• Source: University of Rochester
• Contact: Robin Bender
• Phone: (585) 274-1499
• Email: robin_bender[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 11-17 year-olds.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16000
• Est. completion date: November 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hpv

Intervention

Behavioral:
• Communication
Practice personnel (providers and nurses) receive training in communication about HPV vaccination via an online learning module.
• Standing Orders
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Captured Opportunities for HPV Vaccination	The percentage of eligible patients in each practice aged 11-17 who receive >=1 HPV vaccination within the time frame of interest.	12 month intervention compared to 12 month baseline