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

NCT03609320 | Unknown

• 2 other identifiers: 5R01CA202261R01CA202261
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immunization; Vaccination

Keywords

HPV; Vaccination; Practice Based Intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

The STOP-HPV Trial 5: Bundle Intervention BEHAVIORAL

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.

Single Arm

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.
• None apart from age of patients (above).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Children's Hospital of Philadelphia: collaborator
• American Academy of Pediatrics: collaborator
• University of Pennsylvania: collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• University of Rochester: collaborator

Study Sites (1)

American Academy of Pediatrics

Itasca, Illinois, 60143, United States

Location

Study Officials

• Peter Szilagyi, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Executive Vice-Chair and Vice-Chair for Research, Department of Pediatrics

Model Details: This single-arm study embedded within a 2-arm cluster RCT will test the difference in the rate of missed opportunities pre- and post-implementation of a 3-component intervention including communication skills, performance feedback, and prompts. These three interventions will be implemented together in practices that previously received standard of care.

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: August 1, 2018
• Study Start: January 12, 2022
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)