Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380114
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-18
Brief Title:
Stand Up 2 HPV Standing Orders to Improve HPV Vaccination
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Stand Up 2 HPV Standing Orders to Improve HPV Vaccination
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Each year in the US 20000 women and 14000 men are affected by HPV-related cancers including cervical and oropharyngeal cancer However in 2020 only 59 of US 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 physicians 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 n40 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
Using a 2-arm cluster randomized trial n40 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None