ClinicalTrials.gg
CompletedNCT03599570STOP-HPVUpdated Apr 30, 2020

The STOP-HPV Trial 2: Performance Feedback Intervention

An interventional study of STOP-HPV performance feedback intervention in Immunization and Vaccination, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 11 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-30.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
11 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Immunization
  • Vaccination

Keywords

  • HPV
  • Vaccination
  • Practice based intervention
03

In context

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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).

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Intervention

    Arm 1 will receive the STOP-HPV performance feedback intervention

    Behavioral: STOP-HPV performance feedback intervention

  • No intervention
    Control

    Arm 2 will receive standard of care

Interventions

  • BehavioralSTOP-HPV performance feedback intervention

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

06

What researchers measure

Primary outcomes

  1. Change in the rate of missed vaccination opportunities among all clinicians

    Change in the rate of missed vaccination opportunities from baseline (period 0) through the end of period 2 among all clinicians, with a focus on the contrast between the end of period 1 and period 2.

    Time frame: Monthly for Period 2 and also aggregated over the 6-month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed.

  2. Change in the rate of missed vaccination opportunities among consenting clinicians

    Change in the rate of missed vaccination opportunities from baseline (period 0) through the end of period 2 among consenting clinicians, with a focus on the contrast between periods 1 and 2.

    Time frame: Monthly for Period 2 and also aggregated over the 6-month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed.

07

Study locations

1 site
  • American Academy of Pediatrics
    Itasca, Illinois 60143, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2018 to primary completion in Feb 2020, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2018
First posted
Jul 26, 2018
StartActual
Aug 7, 2018
Primary completionActual
Feb 11, 2020
CompletionActual
Mar 6, 2020
Last update
Apr 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03599570
Responsible party
Peter G Szilagyi, MD MPH (Professor of Pediatrics, Executive Vice-Chair and Vice-Chair for Research, Department of Pediatrics, University of California, Los Angeles) — Principal investigator
First posted
Jul 26, 2018
Start date
Aug 7, 2018
Primary completion
Feb 11, 2020
Completion
Mar 6, 2020
Last update
Apr 30, 2020

Study contacts

Peter Szilagyi, MD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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