- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03599570
The STOP-HPV Trial 2: Performance Feedback Intervention (STOP-HPV)
April 29, 2020 updated by: Peter G Szilagyi, MD MPH, University of California, Los Angeles
Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 2 Comparison of Performance Feedback (in the Presence of Communication Skills) and Standard of Care
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Itasca, Illinois, United States, 60143
- American Academy of Pediatrics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Arm 1 will receive the STOP-HPV performance feedback intervention
|
This intervention will be the addition of performance feedback (in the presence of communication skills).
|
No Intervention: Control
Arm 2 will receive standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the rate of missed vaccination opportunities among all clinicians
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.
|
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.
|
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.
|
Change in the rate of missed vaccination opportunities among consenting clinicians
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.
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Peter Szilagyi, MD, University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2018
Primary Completion (Actual)
February 11, 2020
Study Completion (Actual)
March 6, 2020
Study Registration Dates
First Submitted
June 29, 2018
First Submitted That Met QC Criteria
July 23, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
April 30, 2020
Last Update Submitted That Met QC Criteria
April 29, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2R01CA202261 (U.S. NIH Grant/Contract)
- R01CA202261 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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