The STOP-HPV Trial 3: Prompts Intervention

NCT03599583 | Unknown

• 2 other identifiers: 3R01CA202261R01CA202261
• 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 study is part of a series of cluster randomized clinical trials (RCTs) that will test the effectiveness (and cost-effectiveness) of the addition of prompts (period 3) to performance feedback (period 2, continued through period 3) and training providers previously received on HPV vaccine communication (period 1) 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

  Change in the rate of missed vaccination opportunities separately by dose (initial vs. subsequent) and visit type (preventive vs. acute) among all clinicians.

  The 12-month portion of the pause period immediately preceding initiation of prompts and the 6-month prompts period, excluding the 4-week ramp-up.

• Change in the rate of missed vaccination opportunities among consenting clinicians

  Change in the rate of missed vaccination opportunities separately by dose (initial vs. subsequent) and visit type (preventive vs. acute) among consenting clinicians

  The 12-month portion of the pause period immediately preceding initiation of prompts and the 6-month prompts period, excluding the 4-week ramp-up.

Secondary Outcomes (1)

• Change in the rate of missed vaccination opportunities among clinicians, excluding practices that failed to meet inclusion criteria throughout the study period.

  The 12-month portion of the pause period immediately preceding initiation of prompts and the 6-month prompts period, excluding the 4-week ramp-up

Study Arms (2)

Intervention

EXPERIMENTAL

Arm 1 will receive the STOP-HPV prompts intervention

Behavioral: STOP-HPV prompts intervention

Control

NO INTERVENTION

Arm 2 will receive standard of care

Interventions

STOP-HPV prompts intervention BEHAVIORAL

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

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

Study Officials

• Peter Szilagyi, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

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: RCT study design will test the impact of the prompts intervention to reduce missed opportunities 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 15, 2022
• Study Completion: July 15, 2022
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)