The STOP-HPV Trial 3: Prompts Intervention

NCT ID: NCT03599583

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2022-07-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Arm 1 will receive the STOP-HPV prompts intervention

Group Type: EXPERIMENTAL

STOP-HPV prompts intervention

Intervention Type: BEHAVIORAL

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

Control

Arm 2 will receive standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

-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.

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).

-None apart from age of patients (above).

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

American Academy of Pediatrics

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Peter G Szilagyi, MD MPH

Professor of Pediatrics, Executive Vice-Chair and Vice-Chair for Research, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Szilagyi, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

American Academy of Pediatrics

Itasca, Illinois, United States

Countries

United States

Other Identifiers

R01CA202261

Identifier Type: NIH

Identifier Source: secondary_id

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3R01CA202261

Identifier Type: NIH

Identifier Source: org_study_id

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