Impact of Standing Orders Optimization

NCT ID: NCT05742386

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Human Papilloma Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Communication training

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Communication training enhanced with standing orders optimization

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noel T Brewer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

5P01CA250989-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IMPACTP1SO

Identifier Type: -

Identifier Source: org_study_id