The STOP-HPV Trial 1: Communication Intervention

NCT03599557 | Completed Results

• 2 other identifiers: 1R01CA202261R01CA202261
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 training providers on HPV vaccine communication to reduce MOs and increase HPV vaccination rates.

Conditions

Immunization; Vaccination

Keywords

HPV; Vaccination; Practice based intervention

Outcome Measures

Primary Outcomes (2)

• Change in the Rate of Missed Vaccination Opportunities Among All Clinicians

  The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices, regardless of whether they received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given.

  Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).

• Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians

  The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices who received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given.

  Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).

Study Arms (2)

Intervention

EXPERIMENTAL

Arm 1 will receive the STOP-HPV communication intervention

Behavioral: STOP-HPV communication intervention

Control

NO INTERVENTION

Arm 2 will receive standard of care

Interventions

STOP-HPV communication intervention BEHAVIORAL

This intervention will be communication skills training.

Intervention

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.
• None apart from age of patients (above).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Children's Hospital of Philadelphia: collaborator
• American Academy of Pediatrics: collaborator
• University of Pennsylvania: collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• University of Rochester: collaborator

Study Sites (1)

American Academy of Pediatrics

Itasca, Illinois, 60143, United States

Location

Related Publications (2)

• Fiks AG, Hannan C, Localio R, Kelly MK, Stephens-Shields AJ, Grundmeier RW, Shone LP, Steffes J, Breck A, Wright M, Rand CM, Albertin C, Humiston SG, McFarland G, Abney DE, Szilagyi PG. HPV Vaccinations at Acute Visits and Subsequent Adolescent Preventive Visits. Pediatrics. 2022 Nov 1;150(5):e2022058188. doi: 10.1542/peds.2022-058188. No abstract available.

  PMID: 36205071 DERIVED

• Szilagyi PG, Humiston SG, Stephens-Shields AJ, Localio R, Breck A, Kelly MK, Wright M, Grundmeier RW, Albertin C, Shone LP, Steffes J, Rand CM, Hannan C, Abney DE, McFarland G, Kominski GF, Seixas BV, Fiks AG. Effect of Training Pediatric Clinicians in Human Papillomavirus Communication Strategies on Human Papillomavirus Vaccination Rates: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2021 Sep 1;175(9):901-910. doi: 10.1001/jamapediatrics.2021.0766.

  PMID: 34028494 DERIVED

Results Point of Contact

• Title: Principal Investigator
• Organization: University of California, Los Angeles

pszilagyi@mednet.ucla.edu

(310) 206-6328

Study Officials

• Peter Szilagyi, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Executive Vice-Chair and Vice-Chair for Research, Department of Pediatrics

Model Details: This study will use a cluster RCT study design to test the impact of the communication intervention to reduce missed opportunities (MOs) and raise HPV vaccine rates

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 26, 2018
• Study Start: August 7, 2018
• Primary Completion: July 30, 2019
• Study Completion: October 21, 2019
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)