The STOP-HPV Trial 2: Performance Feedback Intervention

Vaccination Clinical Trial

— STOP-HPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599570
• Other study ID #: 2R01CA202261
• Secondary ID: R01CA202261
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: March 6, 2020

Study information

• Verified date: April 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 6, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Immunization
• Vaccination

Intervention

Behavioral:
• STOP-HPV performance feedback intervention
This intervention will be the addition of performance feedback (in the presence of communication skills).

Locations

Country	Name	City	State
United States	American Academy of Pediatrics	Itasca	Illinois

Sponsors (7)

Lead Sponsor	Collaborator
University of California, Los Angeles	American Academy of Pediatrics, Children's Hospital of Philadelphia, National Cancer Institute (NCI), National Institutes of Health (NIH), University of Pennsylvania, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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.