The STOP-HPV Trial 5: Single Arm Evaluation of the Bundle (STOP_HPV)

Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 5. Single Arm Evaluation of the Bundle (Communication Skills, Performance Feedback and Prompts)

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 single-arm study (embedded within arm 2 of a 2-arm cluster randomized clinical trial (RCT)) will test the effectiveness (and cost-effectiveness) of a bundled intervention (HPV vaccine communication, performance feedback reports and provider prompts), in practices that previously received standard of care, to reduce MOs and increase HPV vaccination rates.

Study Overview

• Status: Active, not recruiting
• Conditions: Vaccination; Immunization
• Intervention / Treatment: Behavioral: The STOP-HPV Trial 5: 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 single-arm study (embedded within arm 2 of a 2-arm cluster RCT) will implement a 3-component bundle intervention together in practices that previously received standard of care. This study will test the effectiveness (and cost-effectiveness) of the bundled intervention, which trains providers in HPV vaccine communication (done through online educational modules and live office practice sessions), provides performance feedback reports (that pull from electronic health record (EHR) data, and compare participants' performance to their own previous performance and performance of others) and 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): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Itasca, Illinois, United States, 60143
      • American Academy of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; These practices, which previously received standard of care, will receive The STOP-HPV Trial 5: Bundle Intervention	Behavioral: The STOP-HPV Trial 5: Bundle Intervention; This intervention will implement a 3-component bundle intervention (communication skills training, performance feedback and prompts) together in practices that previously received standard of care.

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 the 6 month bundle intervention period versus the 12 month period preceding the bundle period among all clinicians.	The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up
Change in the rate of missed vaccination opportunities among consenting clinicians	Change in the rate of missed vaccination opportunities from the 6 month bundle intervention period versus the 12 month period preceding the bundle period among consenting clinicians.	The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up

Secondary 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 among all clinicians.	From months 0 (baseline) through month 28 of study activities. Study activities were paused for a 15 month period during the pandemic.

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): January 12, 2022
• Primary Completion (Anticipated): August 9, 2022
• Study Completion (Anticipated): August 9, 2022

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): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Vaccination; HPV; Practice Based Intervention
• Other Study ID Numbers: 5R01CA202261 (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