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The STOP-HPV Trial 4: Bundle Intervention

NCT ID: NCT03609242

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-07

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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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 cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of a bundled intervention training providers first in HPV vaccine communication skills (done through online educational modules and live office practice sessions), with the addition of performance feedback reports (that pull from electronic health record (EHR) data, and compare participants' performance to their own previous performance and performance of others) followed by the addition of 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.

Conditions

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Immunization Vaccination

Keywords

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HPV Vaccination Practice Based Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Arm 1 will receive the STOP-HPV bundle intervention

Group Type EXPERIMENTAL

STOP-HPV bundle intervention

Intervention Type BEHAVIORAL

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

Control

Arm 2 will receive standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).


-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.

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).


-None apart from age of patients (above).
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

American Academy of Pediatrics

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Peter G Szilagyi, MD MPH

Professor of Pediatrics, Executive Vice-Chair and Vice-Chair for Research, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Szilagyi, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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American Academy of Pediatrics

Itasca, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Abigail Breck

Role: CONTACT

Phone: 1-310-825-7635

Email: [email protected]

Christina Albertin

Role: CONTACT

Phone: 1-317-701-4926

Email: [email protected]

Facility Contacts

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Margaret Wright, PhD

Role: primary

Laura Shone, DrPH

Role: backup

Other Identifiers

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R01CA202261

Identifier Type: NIH

Identifier Source: secondary_id

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4R01CA202261

Identifier Type: NIH

Identifier Source: org_study_id

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