Impact of Standing Orders Optimization

Trial Title: Impact of Standing Orders Optimization

NCT ID: NCT05742386

Condition: Human Papilloma Virus

Conditions: Official terms:
Papilloma

Conditions: Keywords:
Human Papilloma Virus
Pediatric medicine
Primary care
Standing orders
Vaccination

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Cluster randomized design in which clinics will be randomized

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Communication training
Description: Clinics will host an AAT workshop. A trained facilitator will use a standard script and slides to deliver workshop in-person or over Zoom; clinical staff who are unavailable will take the workshop later on their own.
Arm group label: HPV vaccine communication training

Intervention type: Behavioral
Intervention name: Communication training enhanced with standing orders optimization
Description: Clinics will host an AAT workshop, as in the other trial arm. Clinic representatives will attend working meetings on putting HPV vaccine standing orders into clinic workflow. Clinics will then orient their staff to the standing orders. Finally, clinic representatives will discuss their use of standing orders in a learning collaborative.
Arm group label: HPV vaccine communication training and standing orders optimization

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.

Criteria for 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.

Gender: All

Minimum age: 9 Years

Maximum age: 12 Years

Healthy volunteers: No

Locations:

Facility:
Name: The University of North Carolina at Chapel Hill

Address:
City: Chapel Hill
Zip: 27599
Country: United States

Status: Recruiting

Contact:
Last name: Katherine Kritikos

Phone: 919-962-6327
Email: kkritikos@unc.edu

Start date: February 22, 2023

Completion date: July 31, 2026

Lead sponsor:
Agency: UNC Lineberger Comprehensive Cancer Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: UNC Lineberger Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05742386
http://unclineberger.org/patientcare/clinical-trials/clinical-trials