The STOP-HPV Trial 6: Single Arm Evaluation of the Maintenance of the STOP-HPV Bundle

NCT03609372 | Withdrawn

• 2 other identifiers: 6R01CA202261R01CA202261
• Study Type: interventional
• Target: N/A
• 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 evaluation (embedded within arm 1 of a 2-arm cluster randomized clinical trial (RCT)) will test the sustainability of improvement made in response to a bundled intervention including HPV vaccine communication, performance feedback and provider prompts to reduce MOs and increase HPV vaccination rates.

Conditions

Vaccination; Immunization

Keywords

HPV; Vaccination; Practice Based Research

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 baseline through the end of the maintenance period among all clinicians, with a focus on the contrast between the end of the bundled intervention and the maintenance period.

  Monthly from months 0 (baseline) through month 27 (end of maintenance 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 maintenance period among consenting clinicians, with a focus on the contrast between the end of the bundled intervention and the maintenance period.

  Monthly from months 0 (baseline) through month 27 (end of maintenance period), where month 0 is site specific and depends on completion of site staff training and readiness to proceed.

Study Arms (1)

Single arm

EXPERIMENTAL

These practices, which previously received the addition of performance feedback and provider prompts in the presence of communication skills training, will receive The STOP-HPV Trial 6: Maintenance

Behavioral: The STOP-HPV Trial 6: Maintenance

Interventions

The STOP-HPV Trial 6: Maintenance BEHAVIORAL

In this period, study team support will be withdrawn after previous bundled intervention (including HPV vaccine communication, performance feedback and provider prompts) was given to reduce MOs and increase HPV vaccination rates.

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 Szilagry, 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

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: August 1, 2018
• Study Start: August 7, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)