Impact of Standing Orders Optimization

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

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.

Study Overview

• Status: Recruiting
• Conditions: Human Papilloma Virus
• Intervention / Treatment: Behavioral: Communication training; Behavioral: Communication training enhanced with standing orders optimization

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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Kritikos; Phone Number: +1 (919) 962-6327; Email: kkritikos@unc.edu
• Study Contact Backup: Name: Elizabeth Bernstein; Email: elizabeth_bernstein@unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • The University of North Carolina at Chapel Hill
      • Contact: Katherine Kritikos; Phone Number: 919-962-6327; Email: kkritikos@unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPV vaccine communication training; Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination.	Behavioral: Communication training; 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.
Experimental: HPV vaccine communication training and standing orders optimization; Staff in clinics randomized to this arm will receive the AAT and conduct a set of activities to optimize use of HPV vaccine standing orders.	Behavioral: Communication training enhanced with standing orders optimization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV vaccination (≥1 dose), 9-12 year olds	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.	from baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV vaccination (≥1 dose), 9-12 year olds	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.	from 13 months to 24 months
HPV vaccination (≥2 doses), 9-12 year olds	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.	from baseline to 12 months
HPV vaccination (≥2 doses), 9-12 year olds	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.	from 13 months to 24 months
Standing orders attitude rating	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.	up to 6 months
Standing orders norms rating	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.	up to 6 months
Standing orders self-efficacy rating	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.	up to 6 months
Standing orders adoption rating	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.	up to 6 months
Standing orders acceptability rating	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.	up to 6 months
Standing orders appropriateness rating	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.	up to 6 months
Standing orders role rating	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.	up to 6 months
Standing orders feasibility rating	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.	up to 6 months
Standing orders sustainability rating	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.	up to 6 months
Estimated time spent on recommendations	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.	up to 6 months
Estimated recommendation frequency, 9-10 year olds	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.	up to 6 months
Estimated recommendation frequency, 11-12 year olds	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.	up to 6 months
Recommendation attitudes rating	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.	up to 6 months
Recommendation self-efficacy rating	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.	up to 6 months
Recommendation norms rating	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.	up to 6 months
Recommendation intentions rating	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.	up to 6 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Noel T Brewer, PhD, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Primary care; Vaccination; Human Papilloma Virus; Pediatric medicine; Standing orders
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: IMPACTP1SO; 5P01CA250989-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No