Clinical trial NCT05742386: Impact of Standing Orders Optimization
Official title: Evaluating the Impact of Optimizing the Use of HPV Vaccine Standing Orders in Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Papilloma Virus
Keywords: Human Papilloma Virus
Pediatric medicine
Primary care
Standing orders
Vaccination
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-02-24
Enrollment: 28
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized design in which clinics will be randomized
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: HPV vaccination (≥1 dose), 9-12 year olds
timeFrame: from baseline to 12 months
Secondary outcomes:
measure: HPV vaccination (≥1 dose), 9-12 year olds
timeFrame: from 13 months to 24 months
measure: HPV vaccination (≥2 doses), 9-12 year olds
timeFrame: from baseline to 12 months
measure: HPV vaccination (≥2 doses), 9-12 year olds
timeFrame: from 13 months to 24 months
measure: Standing orders attitude rating
timeFrame: up to 6 months
measure: Standing orders norms rating
timeFrame: up to 6 months
measure: Standing orders self-efficacy rating
timeFrame: up to 6 months
measure: Standing orders adoption rating
timeFrame: up to 6 months
measure: Standing orders acceptability rating
timeFrame: up to 6 months
measure: Standing orders appropriateness rating
timeFrame: up to 6 months
measure: Standing orders role rating
timeFrame: up to 6 months
measure: Standing orders feasibility rating
timeFrame: up to 6 months
measure: Standing orders sustainability rating
timeFrame: up to 6 months
measure: Estimated time spent on recommendations
timeFrame: up to 6 months
measure: Estimated recommendation frequency, 9-10 year olds
timeFrame: up to 6 months
measure: Estimated recommendation frequency, 11-12 year olds
timeFrame: up to 6 months
measure: Recommendation attitudes rating
timeFrame: up to 6 months
measure: Recommendation self-efficacy rating
timeFrame: up to 6 months
measure: Recommendation norms rating
timeFrame: up to 6 months
measure: Recommendation intentions rating
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Noel T Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
References: