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The STOP-HPV Trial 3: Prompts Intervention

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Unknown

Conditions

Immunization
Vaccination

Treatments

Behavioral: STOP-HPV prompts intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03599583
R01CA202261 (U.S. NIH Grant/Contract)
3R01CA202261

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

11 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

Intervention
Experimental group
Description:
Arm 1 will receive the STOP-HPV prompts intervention
Treatment:
Behavioral: STOP-HPV prompts intervention
Control
No Intervention group
Description:
Arm 2 will receive standard of care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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