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NCT Number: NCT05742386

Impact of Standing Orders Optimization

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Human Papilloma Virus

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

communication training

Behavioral

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.

Communication training enhanced with standing orders optimization

Behavioral

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.

Primary outcomes

  1. HPV vaccination (≥1 dose), 9-12 year olds

    Time frame: from baseline to 12 months

    Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.

Secondary outcomes

  1. HPV vaccination (≥1 dose), 9-12 year olds

    Time frame: from 13 months to 24 months

    Proportion of unvaccinated children who initiate the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.

  2. HPV vaccination (≥2 doses), 9-12 year olds

    Time frame: from baseline to 12 months

    Proportion of unvaccinated children who complete the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.

  3. HPV vaccination (≥2 doses), 9-12 year olds

    Time frame: from 13 months to 24 months

    Proportion of unvaccinated children who complete the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.

  4. Standing orders attitude rating

    Time frame: up to 6 months

    Positive attitude toward using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more positive attitudes.

  5. Standing orders norms rating

    Time frame: up to 6 months

    Norms in favor of using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more supportive norms.

  6. Standing orders self-efficacy rating

    Time frame: up to 6 months

    Confidence about using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher confidence.

  7. Standing orders adoption rating

    Time frame: up to 6 months

    Adoption of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater adoption.

  8. Standing orders acceptability rating

    Time frame: up to 6 months

    Acceptability of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher acceptability.

  9. Standing orders appropriateness rating

    Time frame: up to 6 months

    Appropriateness of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater appropriateness.

  10. Standing orders role rating

    Time frame: up to 6 months

    Understanding of role under HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating better understanding of role.

  11. Standing orders feasibility rating

    Time frame: up to 6 months

    Feasibility of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater feasibility.

  12. Standing orders sustainability rating

    Time frame: up to 6 months

    Sustainability of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater sustainability.

  13. Estimated time spent on recommendations

    Time frame: up to 6 months

    Time spent on HPV vaccine recommendations will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 0-99 minutes, with higher values indicating more time spent.

  14. Estimated recommendation frequency, 9-10 year olds

    Time frame: up to 6 months

    Frequency of recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more frequent recommendations.

  15. Estimated recommendation frequency, 11-12 year olds

    Time frame: up to 6 months

    Frequency of recommending HPV vaccine for children ages 11 or 12 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more frequent recommendations.

  16. Recommendation attitudes rating

    Time frame: up to 6 months

    Positive attitudes toward recommending HPV vaccine for ages children ages 9 or 10 years will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more positive recommendation attitudes.

  17. Recommendation self-efficacy rating

    Time frame: up to 6 months

    Confidence in recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher recommendation confidence.

  18. Recommendation norms rating

    Time frame: up to 6 months

    Norms in favor of recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more supportive norms.

  19. Recommendation intentions rating

    Time frame: up to 6 months

    Intentions to recommend HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT The range for this measure will be 1 to 5, with higher values indicating higher recommendation intentions.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluating the Impact of Optimizing the Use of HPV Vaccine Standing Orders in Primary Care Clinics

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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