- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03862794
CMO Letter to Reduce Unnecessary Antibiotic Prescribing and Broad Spectrum Prescribing Winter 2018-9 (CMO2018-9)
2. März 2020 aktualisiert von: Public Health England
A Randomized Controlled Trial of Behaviourally Informed Feedback Letters Sent by the Chief Medical Officer on the Amount of Antibiotics and the Percentage of Broad Spectrum Antibiotics Prescribed in Primary Care
This trial aims to reduce unnecessary prescription of antibiotics and broad spectrum antibiotics by general practitioners (GPs) in England.
Unnecessary prescriptions are defined as those that do not improve patient health outcomes.
The intervention is to send GPs a letter from the Chief Medical Officer (CMO) that gives feedback on their practice's prescribing levels.
Specifically the sample was GPs whose practices whose prescribed more than 1.161 items per STAR-PU or whose practices prescribed more that .965
items per STAR-PU and greater than 10% broad spectrum items.
The intervention groups received a letter telling them they are among the highest prescribers of either their total or broad spectrum antibiotics, with a graph showing their prescribing compared to average prescribing ("their peers").
The letter also contained a leaflet to help GPs discuss self-care advice with patients and some advice to use delayed prescriptions.
The investigators hypothesize that the antibiotic prescribing rate in will be lower for the treatment group compared to the control group, following the receipt of the letter.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
7000
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
London, Vereinigtes Königreich, SE1
- Public Health England
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- GP practices that prescribed more than 1.161 Antibacterial Items/STAR-PU for the twelve months (June 2017 - May 2018)
- GP practices that prescribed more than 0.965 Antibacterial Items/STAR-PU and also more than 10% broad spectrum items for the twelve months (June 2017 - May 2018).
Exclusion Criteria:
- none
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: high total and high broad spectrum prescribing letter
social norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average
|
letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average
|
|
Aktiver Komparator: high total and high broad spectrum prescribing control
standard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive the standard practice overall prescribing letter as a control
|
social norm feedback letter used as standard practice, without specific information about the prescribing percentile
|
|
Experimental: high total prescribing only intervention letter
social norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive a letter that has specific information about the percentile they are on for overall prescribing and a bar chart representing their overall prescribing compared to the average
|
letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average
|
|
Aktiver Komparator: high total prescribing control letter
standard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive the standard practice overall prescribing letter as a control
|
social norm feedback letter used as standard practice, without specific information about the prescribing percentile
|
|
Experimental: moderate total prescribing and high broad spectrum letter
social norm feedback letter with bar chart GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum will receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average
|
letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average
|
|
Kein Eingriff: moderate total prescribing and high broad spectrum control
GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive no letter, which is standard practice, as a control.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
total antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) in November for each GP practice
Zeitfenster: 1 month
|
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
|
1 month
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice
Zeitfenster: 1 month
|
broad spectrum antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
|
1 month
|
|
percentage broad spectrum antibiotic prescribing in November for each GP practice
Zeitfenster: 1 month
|
percentage broad spectrum antibiotic prescribing
|
1 month
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice
Zeitfenster: 1 month
|
total overall antibiotic prescribing minus total broad spectrum antibiotic prescribing
|
1 month
|
|
total antibiotic prescribing weighted by STAR-PU in December for each GP practice
Zeitfenster: 2 months
|
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
|
2 months
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice
Zeitfenster: 2 months
|
2 months
|
|
|
percentage broad spectrum antibiotic prescribing in December for each GP practice
Zeitfenster: 2 months
|
2 months
|
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice
Zeitfenster: 2 months
|
2 months
|
|
|
total antibiotic prescribing in January weighted by STAR-PU for each GP practice
Zeitfenster: 3 months
|
3 months
|
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice
Zeitfenster: 3 months
|
3 months
|
|
|
percentage broad spectrum antibiotic prescribing in January for each GP practice
Zeitfenster: 3 months
|
3 months
|
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice
Zeitfenster: 3 months
|
3 months
|
|
|
total antibiotic prescribing weighted by STAR-PU in February for each GP practice
Zeitfenster: 4 months
|
4 months
|
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice
Zeitfenster: 4 months
|
4 months
|
|
|
percentage broad spectrum antibiotic prescribing in February for each GP practice
Zeitfenster: 4 months
|
4 months
|
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice
Zeitfenster: 4 months
|
4 months
|
|
|
total antibiotic prescribing weighted by STAR-PU in March for each GP practice
Zeitfenster: 5 months
|
5 months
|
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice
Zeitfenster: 5 months
|
5 months
|
|
|
percentage broad spectrum antibiotic prescribing in March for each GP practice
Zeitfenster: 5 months
|
5 months
|
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice
Zeitfenster: 5 months
|
5 months
|
|
|
total antibiotic prescribing weighted by STAR-PU in April for each GP practice
Zeitfenster: 6 months
|
6 months
|
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice
Zeitfenster: 6 months
|
6 months
|
|
|
percentage broad spectrum antibiotic prescribing in April for each GP practice
Zeitfenster: 6 months
|
6 months
|
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice
Zeitfenster: 6 months
|
6 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. November 2018
Primärer Abschluss (Tatsächlich)
30. April 2019
Studienabschluss (Tatsächlich)
30. Mai 2019
Studienanmeldedaten
Zuerst eingereicht
27. Februar 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. März 2019
Zuerst gepostet (Tatsächlich)
5. März 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. März 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. März 2020
Zuletzt verifiziert
1. Dezember 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- R&D 193
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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