Impact of Standing Orders Optimization
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About
This trial will look at the impact of optimizing human papillomavirus (HPV) vaccine standing orders. The research team will work with primary care clinics. Some clinics will receive communication training. Other clinics will receive the same training and tools for increasing the use of their standing orders.
Full description
The researchers will conduct a cluster randomized clinical trial. The trial will look at the impact of optimizing HPV vaccine standing orders. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive a communication training. Other clinics will receive a communication training and tools for optimizing the use of their standing orders. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 months. The researchers will also use survey data to compare HPV vaccine communication and implementation of standing orders among clinical staff. The study will engage clinical staff. Researchers will not have direct contact with children or their families.
Enrollment
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Volunteers
Inclusion and exclusion criteria
This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children and survey data from clinical staff to evaluate intervention effectiveness. We will not enroll children or interact with them directly.
Inclusion Criteria
Clinics are eligible if they:
- provide HPV vaccine to children ages 9-12
- have standing orders for HPV vaccination approved but not routinely used or be willing to adopt them prior to the start of the trial
- have rates of HPV vaccination (≥1 dose) below 72%, boys and girls combined
Children's medical records will be eligible to be included in the dataset if children:
- are between the ages of 9-12 years at baseline
- are attributed to a participating clinic at 12- or 24-month follow-up
Clinical staff's survey data will be eligible to be included in the dataset if clinical staff complete the follow-up survey.
Exclusion Criteria
Clinics are excluded if they:
- do not provide HPV vaccine to children ages 9-12
- do not have standing orders for HPV vaccination or are not willing to adopt them prior to the start of the trial
- have rates of HPV vaccination (≥1 dose) above 72%, boys and girls combined
- have hosted an AAT workshop in the previous 3 years or are part of current HPV vaccine communication trainings
- have quality improvement efforts to change HPV vaccine standing orders during the trial
Children's medical records will not be eligible to be included in the dataset if children:
- are not between the ages of 9-12 years at baseline
- are not attributed to a participating clinic at 12- or 24-month follow-up
- are receiving hospice/palliative care, are pregnant, or have a history of HPV vaccine contraindications
Clinical staff's survey data will be not eligible to be included in the dataset if clinical staff do not complete the follow-up survey.
Trial design
Primary purpose
Allocation
Interventional model
Masking
28 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Katherine Kritikos; Elizabeth Bernstein
Data sourced from clinicaltrials.gov
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