Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Eine Infektion mit HPV kann zur Entstehung von Krebs führen. In der Schweiz empfiehlt das BAG daher eine Impfung gegen HPV, welche bisher vor allem von Kinderärzten*innen und Frauenärzten*innen durchgeführt wird. Die Impfquote in der Schweiz ist jedoch unter der vom BAG empfohlenen Marke von 80%. Bisherige Studien haben gezeigt, dass besonders in der Hausarztmedizin grosses Potential besteht zu einer Verbesserung der nationalen Impfquote beizutragen. Ziel dieser Studie ist es daher zu prüfen, ob eine gezielte, vielschichtige Fortbildung für Hausärzte*innen zu einer Erhöhung der Impfquote führt.
Malattie studiate(Fonte di dati: BASEC)
Primärprävention einer Infektion mit humanen Papillomaviren (HPV).
Health conditions
(Fonte di dati: WHO)
Human papillomavirus
Infections and Infestations
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
In dieser Studie wird geprüft, ob eine gezielte, vielschichtige Fortbildung für Hausärzte*innen zu einer Erhöhung der Impfquote führt. Diese Fortbildung enthält detaillierte Informationen über 1) HPV und HPV Impfungen, 2) Informationen wie Impfungen am besten mit Patienten*innen kommuniziert werden können, 3) allgemeine Informationen zu administrativen und logistischen Punkten im Kontext der HPV Impfung.
Ärzte*innen in der Kontrollgruppe bekommen eine Fortbildung über Impfungen im Allgemeinen. Da diese Fortbildung das Impfverhalten der Ärzte*innen in der Kontrollgruppe auch beeinflussen kann, erhalten auch die Ärzte*innen in der Interventionsgruppe diese Fortbildung. Ärzte*innen in der Kontrollgruppe kennen den wahren Zweck der Studie nicht.
Interventions
(Fonte di dati: WHO)
Study physicians will be randomized into two groups (control and intervention). A statistician not involved in the study performs the randomization. They will use stratified randomization.
1. GPs who are not already a member of the cantonal vaccination programs are randomized after stratification
2. GP practice level. If more than one GP from the same practice participates in the study, the researchers will allocate them to the same group
3. Number of performed HPVv during the baseline period
Both groups receive a general study instruction, which consists of basic information about the order of the study, study conduct and reporting. Both groups will receive a basic educational session about vaccination.
Control group:
All GPs in the control group will receive a basic educational session about vaccination and the current national vaccination recommendations. The session will include all basic information about HPV and HPV vaccination to ensure that all GPs know how to provide vaccinations according to the current recommendations.
Intervention group:
In addition to the basic educational session about vaccinations, GPs in the intervention group will receive an intervention consisting of three parts:
1. Detailed information about HPV and HPVv
2. Information about the announcement communication method in delivering vaccinations
3. Information about logistics and administrative issues regarding the HPVv
Duration of the intervention: about 3-4 hours of training.
Follow-up. There is no specific follow up of patients in this study
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
Ebene Arzt:
- Arzt/Ärztin arbeitet in der Grundversorgung und bietet die folgenden Impfungen gemäss dem Schweizer Impfplan an: Mumps/Masern/Röteln, Meningokokken, Pneumokokken, HPV, FSME, Varizellen, Herpes Zoster und Hepatitis A/B.
Ebene Patient:
- Es können alle Patienten*innen eingeschlossen werden, welche sich gemäss dem Schweizer Impfplan für eine der genannten Impfungen qualifizieren.
Criteri di esclusione
(Fonte di dati: BASEC)
Ebene Arzt:
- Arzt/Ärztin arbeitet mehrheitlich (>50%) pädiatrisch.
- Arzt/Ärztin arbeitet mehrheitlich (>50%) gynäkologisch.
- Arzt/Ärztin ist Schularzt oder führt Impfungen an Schulen durch.
Ebene Patient:
- Für Patienten*innen gelten die Ausschlusskriterien für die genannten Impfungen gemäss dem aktuellen Schweizer Impfplan.
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: Both
Inclusion criteria: The study patient population is equal to the target population of the vaccines of interest. GPs will provide vaccinations according to the current Swiss vaccination recommendations publicized by the Swiss Ministry of Health (Swiss vaccination schedule 2020)
Exclusion criteria: Does not meet inclusion criteria
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
4 giu 2021
Inserimento del primo partecipante
1 set 2021
Stato di reclutamento
Completed
Titolo scientifico
(Fonte di dati: WHO)
Impact of a multifaceted, targeted intervention on the human papillomavirus vaccination rate in Swiss Primary Care: a cluster randomized controlled trial
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Prospective cluster randomized controlled trial (Prevention)
Fase
(Fonte di dati: WHO)
Not Applicable
Punti finali primari
(Fonte di dati: WHO)
Overall number of HPVv given in the first 6 months, reported in a specific case report form (CRF) at month 6
Punti finali secondari
(Fonte di dati: WHO)
Current secondary outcome measures as of 13/02/2023:
1. HPVv uptake (1st dose [with exception of baseline period and month 6] and overall vaccination doses) in the intervention group and control group, reported in a specific case report form (CRF) during the baseline period and at 3, 6, and 12 months
2. The change in HPVv uptake (overall vaccination doses) reported in a specific case report form (CRF) from baseline to defined time points (3, 6 and 12 months) between the intervention group and control group
3. The change in HPV and HPVv knowledge and attitudes (at GP level) measured using a questionnaire at baseline and month 6
4. Basic demographic data of HPV vaccinated patients (gender and age), provided by GPs in the CRF after 6 and 12 months
5. HPVv first vaccination or booster vaccination, request of patient or recommendation by GP (or both), and HPVv given alone or in combination with other vaccines, provided by GPs in the CRF after 6 and 12 months
_____
Previous secondary outcome measures:
1. HPVv uptake (1st dose [with exception of baseline period and month 6] and overall vaccination doses) in the intervention group and control group, reported in a specific case report form (CRF) during the baseline period and at 2, 4, 6, and 12 months
2. The change in HPVv uptake (overall vaccination doses) reported in a specific case report form (CRF) from baseline to defined timepoints (2, 4, 6 and 12 months) between the intervention group and control group
3. The change in HPV and HPVv knowledge and attitudes (at GP level) measured using a questionnaire at baseline and month 6
4. Basic demographic data of HPV vaccinated patients (gender and age), provided by GPs in the CRF after 6 and 12 months
5. HPVv first vaccination or booster vaccination, request of patient or recommendation by GP (or both), and HPVv given alone or in combination with other vaccines, provided by GPs in the CRF after 6 and 12 months
Contatto per informazioni
(Fonte di dati: WHO)
Merck Sharp and Dohme, Universit?tsspital Z?rich, Universit?t Z?rich
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
Data sharing statement to be made available at a later date
All results will be published in an international peer-reviewed journal. Currently no further documents are available.
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Dr. med. Andreas Plate
+41 44 255 7503
Andreas.Plate@usz.ch
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Andreas
Plate
Pestalozzistrasse 24
+41 (0)442557503
andreas.plate@usz.ch
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Kantonale
Ethikkommission Zürich
Data di autorizzazione da parte della commissione d’etica
08.12.2020
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2020-02341
Secondary ID (Fonte di dati: WHO)
Nil known
1.2
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