The STOP-HPV Trial 3: Prompts Intervention (STOP-HPV)

Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 3. Comparison of Prompts (in the Presence of Communication Skills and Performance Feedback) 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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vaccination; Immunization
• Intervention / Treatment: Behavioral: STOP-HPV prompts intervention

Detailed Description

This intervention will incorporate prompts via electronic health record (EHR) (e.g. alerts in electronic charts indicating patient is due for vaccination) and study practice staff prompts (reminders from study staff that a patient is due for vaccination, e.g. placing Vaccine Information Statements (VISs) on desk) to study practitioners that encourage HPV vaccination at all visits. An initial learning module on practitioner prompts will highlight how study practices can consistently implement both EHR and staff HPV vaccination prompts at all visits. Throughout the intervention, text message mini-lessons will remind participants how to best use prompts via EHR and/or office staff to improve HPV vaccination rates. This trial focuses on study period 3 where study periods are as follows:

Period 0: Baseline period, prior to the randomization of practices into intervention arms

Period 1: Arm-1 intervention study practices receive communication skills training; Arm-2 comparison study practices provide standard of care. Period 2: Arm-1 intervention study practices add performance feedback, building upon their prior training in communication skills; Arm-2 comparison study practices continue delivering standard of care. Period 3: Arm-1 intervention study practices add prompts, building upon prior communication skills and performance feedback; Arm-2 comparison study practices continue with standard of care.

Due to the COVID-19 pandemic, an additional 15-month study period (Pause Period) was introduced between feedback (Period 2) and prompts (Period 3). No study activities were undertaken during this time.

The prompts intervention effect will be interpreted within the context of the previous periods (Periods 0, 1 and 2) and the pause period.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Itasca, Illinois, United States, 60143
      • American Academy of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• 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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Arm 2 will receive standard of care
Experimental: Intervention; Arm 1 will receive the STOP-HPV prompts intervention	Behavioral: STOP-HPV prompts intervention; This intervention will be the addition of the prompts intervention (in the presence of communication skills training and continued performance feedback).

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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the rate of missed vaccination opportunities among clinicians, excluding practices that failed to meet inclusion criteria throughout the study period.	Change in the rate of missed vaccination opportunities separately by dose (initial vs. subsequent) and visit type (preventive vs. acute) 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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Cancer Institute (NCI); Children's Hospital of Philadelphia; University of Pennsylvania; National Institutes of Health (NIH); University of Rochester; American Academy of Pediatrics
• Investigators: Principal Investigator: Peter Szilagyi, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): July 15, 2022

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): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Vaccination; HPV; Practice based intervention
• Other Study ID Numbers: 3R01CA202261 (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