Impact of Standing Orders Optimization

Last updated: May 27, 2025
Sponsor: UNC Lineberger Comprehensive Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Communication training

Communication training enhanced with standing orders optimization

Clinical Study ID

NCT05742386
IMPACTP1SO
5P01CA250989-02
  • Ages 9-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Communication training
Phase:
Study Start date:
February 22, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

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