Recruiting

Bundle Intervention

Sponsor:

UCLA

Code:

NCT03609242

Conditions

Immunization

Vaccination

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Accepted

Interventions

STOP-HPV bundle intervention

Study Details

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

Study ID

NCT03609242

Start date

Aug 7, 2018

Status verified date

Dec, 2020

Completion date

Mar, 2021

Anticipated

Primary completion date

Mar, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Accepted

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 Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention

Arm 1 will receive the STOP-HPV bundle intervention

no intervention: Control

Arm 2 will receive standard of care

Interventions

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).

Primary outcome measure

  • Change in the rate of missed vaccination opportunities among all clinicians [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Abigail Breck

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

Christina Albertin

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

Locations

American Academy of Pediatrics

Recruiting

Itasca, Illinois, United States, 60143

Contacts

Margaret Wright, PhD

630-626-6629MWright@aap.org

Laura Shone, DrPH

630-626-6710lshone@aap.org

More Information

Sponsor

University of California, Los Angeles

Last update posted

Dec 11, 2020

Last verified

Dec, 2020

Keywords

  • HPV
  • Vaccination
  • Practice Based Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2020-12-11.