NCT03599583

The STOP-HPV Trial 3: Prompts Intervention

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Immunization
• Vaccination

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-08-07
• Primary completion: 2022-07-15
• Completion: 2022-07-15
• First posted: 2018-07-26
• Last updated: 2022-01-12

Locations

1 site across 1 country: United States