The STOP-HPV Trial 4: Bundle Intervention

NCT03609242 | Unknown

• 2 other identifiers: 4R01CA202261R01CA202261
• Study Type: interventional
• Target: 48
• 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 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.

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 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.

Study Arms (2)

Intervention

EXPERIMENTAL

Arm 1 will receive the STOP-HPV bundle intervention

Behavioral: STOP-HPV bundle intervention

Control

NO INTERVENTION

Arm 2 will receive standard of care

Interventions

STOP-HPV bundle intervention BEHAVIORAL

This intervention will be the bundle (training in communication skills, with the addition of performance feedback followed by the addition of provider prompts).

Intervention

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

RECRUITING

Study Officials

• Peter Szilagyi, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Breck

CONTACT

1-310-825-7635; abreck@mednet.ucla.edu

Christina Albertin

CONTACT

1-317-701-4926; Christina_Albertin@URMC.Rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• 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: Cluster RCT study design will test the impact of the bundle (communication still training, performance feedback and prompts) to reduce missed opportunities and raise HPV vaccine rates.

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: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)