The STOP-HPV Trial 4: Bundle Intervention (STOP-HPV)

Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 4. Comparison of the Bundle (Communication Skills, Performance Feedback and Prompts) and Standard of Care

Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of HPV vaccine communication, performance feedback reports and provider prompts (the bundle) to reduce MOs and increase HPV vaccination rates.

Study Overview

• Status: Unknown
• Conditions: Vaccination; Immunization
• Intervention / Treatment: Behavioral: STOP-HPV bundle intervention

Detailed Description

HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities (MOs) are healthcare visits during which a patient is eligible, but does not receive a vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of a bundled intervention training providers first in HPV vaccine communication skills (done through online educational modules and live office practice sessions), with the addition of performance feedback reports (that pull from electronic health record (EHR) data, and compare participants' performance to their own previous performance and performance of others) followed by the addition of provider prompts (via EHR and also office staff prompts, e.g., placing Vaccine Information Statements (VISs) on desk) to reduce MOs and increase HPV vaccination rates. Throughout the intervention participants will also receive weekly text message mini-lessons that will remind participants of the project.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abigail Breck; Phone Number: 1-310-825-7635; Email: abreck@mednet.ucla.edu
• Study Contact Backup: Name: Christina Albertin; Phone Number: 1-317-701-4926; Email: Christina_Albertin@URMC.Rochester.edu

Study Locations

• United States
  • Illinois
    • Itasca, Illinois, United States, 60143
      • Recruiting
      • American Academy of Pediatrics
      • Contact: Margaret Wright, PhD; Phone Number: 630-626-6629; Email: MWright@aap.org
      • Contact: Laura Shone, DrPH; Phone Number: 630-626-6710; Email: lshone@aap.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Practice Inclusion Criteria:

• The practice provides HPV vaccination services to adolescents.
• The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).
• The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).
• The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).

Practice Exclusion Criteria:

• The practice plans to change EHR systems in the next three years.
• The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).
• Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).

Patient inclusion criteria:

-All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.

Patient exclusion criteria:

-None apart from age of patients (above).

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
No Intervention: Control; Arm 2 will receive standard of care
Experimental: Intervention; Arm 1 will receive the STOP-HPV bundle intervention	Behavioral: STOP-HPV bundle intervention; This intervention will be the bundle (training in communication skills, with the addition of performance feedback followed by the addition of provider prompts).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the rate of missed vaccination opportunities among all clinicians	Change in the rate of missed vaccination opportunities from baseline through the end of the bundle intervention period among all clinicians	Monthly from months 0 (baseline) through month 21 (end of the bundle intervention period), where month 0 is site specific and depends on completion of site staff training and readiness to proceed.
Change in the rate of missed vaccination opportunities among consenting clinicians	Change in the rate of missed vaccination opportunities from baseline through the end of the bundle intervention period among consenting clinicians	Monthly from months 0 (baseline) through month 21 (end of the bundle intervention period), where month 0 is site specific and depends on completion of site staff training and readiness to proceed.

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Cancer Institute (NCI); Children's Hospital of Philadelphia; University of Pennsylvania; National Institutes of Health (NIH); University of Rochester; American Academy of Pediatrics
• Investigators: Principal Investigator: Peter Szilagyi, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Vaccination; HPV; Practice Based Intervention
• Other Study ID Numbers: 4R01CA202261 (U.S. NIH Grant/Contract); R01CA202261 (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