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The STOP-HPV Trial 5: Single Arm Evaluation of the Bundle (STOP_HPV)

29. juni 2022 opdateret af: Peter G Szilagyi, MD MPH, University of California, Los Angeles

Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 5. Single Arm Evaluation of the Bundle (Communication Skills, Performance Feedback and Prompts)

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 single-arm study (embedded within arm 2 of a 2-arm cluster randomized clinical trial (RCT)) will test the effectiveness (and cost-effectiveness) of a bundled intervention (HPV vaccine communication, performance feedback reports and provider prompts), in practices that previously received standard of care, to reduce MOs and increase HPV vaccination rates.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities (MOs) are healthcare visits during which a patient is eligible, but does not receive a vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This single-arm study (embedded within arm 2 of a 2-arm cluster RCT) will implement a 3-component bundle intervention together in practices that previously received standard of care. This study will test the effectiveness (and cost-effectiveness) of the bundled intervention, which trains providers in HPV vaccine communication (done through online educational modules and live office practice sessions), provides performance feedback reports (that pull from electronic health record (EHR) data, and compare participants' performance to their own previous performance and performance of others) and provider prompts (via EHR and also office staff prompts, e.g., placing Vaccine Information Statements (VISs) on desk) to reduce MOs and increase HPV vaccination rates. Throughout the intervention participants will also receive weekly text message mini-lessons that will remind participants of the project.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Itasca, Illinois, Forenede Stater, 60143
        • American Academy of Pediatrics

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

11 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single Arm
These practices, which previously received standard of care, will receive The STOP-HPV Trial 5: Bundle Intervention
Adfærdsmæssigt: The STOP-HPV Trial 5: Bundle Intervention
This intervention will implement a 3-component bundle intervention (communication skills training, performance feedback and prompts) together in practices that previously received standard of care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the rate of missed vaccination opportunities among all clinicians
Tidsramme: The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up
Change in the rate of missed vaccination opportunities from the 6 month bundle intervention period versus the 12 month period preceding the bundle period among all clinicians.
The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up
Change in the rate of missed vaccination opportunities among consenting clinicians
Tidsramme: The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up
Change in the rate of missed vaccination opportunities from the 6 month bundle intervention period versus the 12 month period preceding the bundle period among consenting clinicians.
The 12-month period immediately preceding initiation of the bundle and the 6-month bundle period, excluding the 6-week ramp-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the rate of missed vaccination opportunities among all clinicians.
Tidsramme: From months 0 (baseline) through month 28 of study activities. Study activities were paused for a 15 month period during the pandemic.
Change in the rate of missed vaccination opportunities among all clinicians.
From months 0 (baseline) through month 28 of study activities. Study activities were paused for a 15 month period during the pandemic.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Los Angeles

Samarbejdspartnere

National Cancer Institute (NCI)
Children's Hospital of Philadelphia
University of Pennsylvania
National Institutes of Health (NIH)
University of Rochester
American Academy of Pediatrics

Efterforskere

  • Ledende efterforsker: Peter Szilagyi, MD, University of California, Los Angeles

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. januar 2022

Primær færdiggørelse (Forventet)

9. august 2022

Studieafslutning (Forventet)

9. august 2022

Datoer for studieregistrering

Først indsendt

29. juni 2018

Først indsendt, der opfyldte QC-kriterier

23. juli 2018

Først opslået (Faktiske)

1. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 5R01CA202261 (U.S. NIH-bevilling/kontrakt)
  • R01CA202261 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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Ingen

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Kliniske forsøg med Vaccination

Kliniske forsøg med The STOP-HPV Trial 5: Bundle Intervention

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Austria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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