The STOP-HPV Trial 2: Performance Feedback Intervention

NCT ID: NCT03599570

Last Updated: 2020-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2020-03-06

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 the addition of performance feedback (period 2) to training providers previously received on HPV vaccine communication (period 1) to reduce MOs and increase HPV vaccination rates.

Detailed Description

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 trial focuses on period 2, the addition of performance feedback in the presence of communication skills training. Arm-1 intervention study practices add performance feedback (period 2), building upon their prior training in communication skills (period 1); Arm-2 comparison study practices continue delivering standard of care. During this period, the investigators will be measuring captured opportunities - the inverse of MOs, or visits when an eligible patient receives a vaccine. Providers rarely receive feedback to track their captured opportunities, but feedback has been shown to be an effective tool. Performance feedback reports will pull from electronic health record (EHR) data, and will compare participants performance to their own previous performance and those of others. Throughout the intervention participants will also receive weekly text message mini-lessons that will remind participants of the project.

Conditions

Immunization; Vaccination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Arm 1 will receive the STOP-HPV performance feedback intervention

Group Type: EXPERIMENTAL

STOP-HPV performance feedback intervention

Intervention Type: BEHAVIORAL

This intervention will be the addition of performance feedback (in the presence of communication skills).

Control

Arm 2 will receive standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

STOP-HPV performance feedback intervention

This intervention will be the addition of performance feedback (in the presence of communication skills).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

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

Peter Szilagyi, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

American Academy of Pediatrics

Itasca, Illinois, United States

Countries

United States

Other Identifiers

R01CA202261

Identifier Type: NIH

Identifier Source: secondary_id

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2R01CA202261

Identifier Type: NIH

Identifier Source: org_study_id

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