Impact of Standing Orders Optimization

NCT05742386 | Active Not Recruiting

• 2 other identifiers: IMPACTP1SO5P01CA250989-02
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papilloma Virus

Keywords

Human Papilloma Virus; Pediatric medicine; Primary care; Standing orders; Vaccination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

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

  from 13 months to 24 months

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

  from baseline to 12 months

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

  from 13 months to 24 months

• Standing orders attitude rating

  up to 6 months

• Standing orders norms rating

  up to 6 months

Study Arms (2)

HPV vaccine communication training

EXPERIMENTAL

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

HPV vaccine communication training and standing orders optimization

EXPERIMENTAL

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

Interventions

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.

HPV vaccine communication training

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.

HPV vaccine communication training and standing orders optimization

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study Officials

• Noel T Brewer, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized design in which clinics will be randomized

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 24, 2023
• Study Start: February 22, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)