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Enhancing a Sustainable Pharmacy-based Immunization Program in Two States

11. juli 2019 oppdatert av: Salisa Westrick, Auburn University

Impact of a Multicomponent Immunization Intervention on Pneumococcal and Herpes Zoster Vaccinations: A Randomized Controlled Trial of Community Pharmacies in 2 States

The study's aim is to enhance current immunization activities in community pharmacies through targeting the two most commonly available non-seasonal vaccines in community pharmacies, namely pneumococcal and herpes zoster vaccination services. The study will compare the change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month intervention period between intervention pharmacies and the control pharmacies.

Studieoversikt

Detaljert beskrivelse

Community pharmacies are in a unique position and have potential to help increase immunization rates, especially among those who do not visit their primary care provider regularly. This study seeks to increase the level of pharmacy-based immunization delivery.

The study intervention is designed to increase the current level of pharmacy-based immunization delivery and foster practice change to sustain the intervention effect. Our intervention combines evidence-based strategies for improving immunization coverage and strategies to overcome system barriers to increase sustainability of the intervention over time. The study will focus on pneumococcal and herpes zoster vaccination services.

Specific aims include:

  1. To compare the change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month intervention period between intervention pharmacies and the control pharmacies. The pre-intervention period will correspond to the intervention period.
  2. To compare the extent of immunization activity implementation during the intervention period between intervention pharmacies and control pharmacies.
  3. To compare the level of sustainability of immunization services over the period of 6 months after the intervention period ends between the intervention group and the control group.
  4. To explore facilitators and barriers to implementing immunization services.
  5. To explore factors affecting patient acceptance of pharmacist's vaccine recommendations within the intervention pharmacies.

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Alabama
      • Auburn, Alabama, Forente stater, 36830
        • Auburn University
    • California
      • Claremont, California, Forente stater, 91711
        • Keck Graduate Institute School of Pharmacy

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Alabama and California community pharmacies
  • Must provide in-store prescription-dispensing service
  • Must provide pneumococcal vaccine and/or herpes zoster

Exclusion Criteria:

  • Must have no plan to close or change the ownership in the next 12 months

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Enhanced immunization delivery model
Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.
Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.
Basic immunization update online webinar will summarize changes in immunization schedules.
Aktiv komparator: Immunization update
Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.
Basic immunization update online webinar will summarize changes in immunization schedules.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Herpes Zoster and Pneumococcal Vaccinations Administered
Tidsramme: 6 months
The change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy during the 6-month intervention period from the 6-month baseline.
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Strategies Implemented to Promote Immunization Activities
Tidsramme: 6 months
During the study, pharmacist-technician pairs engaged in on-going strategies used to advertise, market and assess non-seasonal immunization service processes. Of the total of 10 strategies possible, each pair selected strategies that they implemented. Results were reported by a representative from each pharmacy unit.
6 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Level of Sustainability of Immunization Services
Tidsramme: 24 months
Change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from 12 Months Pre- to 12 Months Post-Intervention. A representative of each pharmacy unit reported vaccine doses.
24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Salisa C Westrick, PhD, Auburn University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2015

Primær fullføring (Faktiske)

1. oktober 2017

Studiet fullført (Faktiske)

1. desember 2017

Datoer for studieregistrering

Først innsendt

19. november 2015

Først innsendt som oppfylte QC-kriteriene

25. november 2015

Først lagt ut (Anslag)

26. november 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juli 2019

Sist bekreftet

1. juli 2019

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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