- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02615470
Enhancing a Sustainable Pharmacy-based Immunization Program in Two States
Impact of a Multicomponent Immunization Intervention on Pneumococcal and Herpes Zoster Vaccinations: A Randomized Controlled Trial of Community Pharmacies in 2 States
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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:
- 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.
- To compare the extent of immunization activity implementation during the intervention period between intervention pharmacies and control pharmacies.
- 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.
- To explore facilitators and barriers to implementing immunization services.
- To explore factors affecting patient acceptance of pharmacist's vaccine recommendations within the intervention pharmacies.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Alabama
-
Auburn, Alabama, Verenigde Staten, 36830
- Auburn University
-
-
California
-
Claremont, California, Verenigde Staten, 91711
- Keck Graduate Institute School of Pharmacy
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Herpes Zoster and Pneumococcal Vaccinations Administered
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Strategies Implemented to Promote Immunization Activities
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The Level of Sustainability of Immunization Services
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Salisa C Westrick, PhD, Auburn University
Publicaties en nuttige links
Algemene publicaties
- Hastings TJ, Hohmann LA, Huston SA, Ha D, Westrick SC, Garza KB. Enhancing pharmacy personnel immunization-related confidence, perceived barriers, and perceived influence: The We Immunize program. J Am Pharm Assoc (2003). 2020 Mar-Apr;60(2):344-351.e2. doi: 10.1016/j.japh.2019.10.005. Epub 2019 Nov 14.
- Hohmann LA, Hastings TJ, Ha DR, Garza KB, Huston SA, Chen L, Westrick SC. Impact of a multi-component immunization intervention on pneumococcal and herpes zoster vaccinations: A randomized controlled trial of community pharmacies in 2 states. Res Social Adm Pharm. 2019 Dec;15(12):1453-1463. doi: 10.1016/j.sapharm.2019.01.006. Epub 2019 Feb 7.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MISP53380
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Enhanced immunization delivery model
-
University of California, San DiegoNational Institute of Mental Health (NIMH); Kaiser PermanenteAanmelden op uitnodigingAutisme Spectrum Stoornis | Mentale gezondheid | Implementatie Wetenschap | GedragsgezondheidVerenigde Staten
-
Sabine Mueller, MD, PhDPacific Pediatric Neuro-Oncology Consortium; The V Foundation for Cancer ResearchVoltooidDiffuus intrinsiek ponsglioomVerenigde Staten