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CMO Letter to Reduce Inappropriate Antibiotic Prescribing Winter 2019/2020

28. September 2020 aktualisiert von: Public Health England

A Letter From the CMO in England to Reduce Antibiotic Prescribing in General Practice: A Randomized Controlled Trial Comparing Monitoring and Feedback (With and Without Graphs), and Social Norms Feedback (Without and Without a Specific Case Study of Patient Harm)

This trial aims to reduce inappropriate 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.

There will be three intervention samples:

  1. practices whose prescribing in the past year was under the new target of 0.965 items per STAR-PU but who would exceed the target if they had a 5% increase in prescribing; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing is just under the new target to that of practices that are not sent a letter
  2. Practices whose prescribing in the past year was above the new target but who not in the top 20% of prescribers; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing exceeds the new target to practices who get a letter that includes a graph showing their prescribing relative to the target and to practices that are not sent a letter
  3. Practices that are currently in the top 20% of prescribers; trial compares effect on prescribing of a feedback letter with a social norms message (current standard practice for this group) to a letter informing GPs that their practice's prescribing exceeds the new target and to a letter with a social norms message, that includes a specific example of a case of patient harm caused by antimicrobial resistance.

Studienübersicht

Status

Abgeschlossen

Intervention / Behandlung

Detaillierte Beschreibung

The study will involve three trials, each conducted as non-blinded randomised controlled trial, with GP practices as the unit of randomisation.

Trial 1 Targeting practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing

  • Control: No letter
  • Intervention: Letter informing them that their practice's prescribing is just under the new target (Letter A) Trial hypothesis: Sending a letter to GPs whose practices are just under the new prescribing target will reduce antibiotic prescribing

Trial 2 Targeting practices whose prescribing in the past year was above the new target but who not in the top 20% of prescribers

  • Control: No letter
  • Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter B1)
  • Intervention 2: Letter informing them that their practice's prescribing exceeds the new target with a graph representing prescribing relative to the target (Letter B2) Hypotheses: (i) Sending a letter to GPs whose practices missed the new prescribing target will reduce their prescribing; (ii) A letter with a graph will be more effective than a letter without a graph.

Trial 3 Targeting practices that are currently in the top 20% of prescribers

  • Control: Current standard practice, a social norms message, that their practice is in the top 20% of prescribers (Letter C1)
  • Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter C2)
  • Intervention 2: Social norms message, that they are in the top 20%, with a specific example of a case of patient harm caused by antimicrobial resistance (Letter C3)

Hypotheses: (i) A letter with a social norms message and a specific example of a case where a patient came to harm will be more effective than a feedback letter without a specific example; (ii) A letter telling GPs that they missed the prescribing target will be no less effective than a letter with social norms feedback

For each letter, there will be two versions, one for practices whose prescribing has increased by > 5% in the previous year, informing them of that their prescribing has increased since the previous year, and one for practices whose prescribing has not been increasing.

The letters will signpost GPs to resources to help address patient demand for inappropriate antibiotic prescribing, recognising that many GPs feel that patients expect antibiotics and that GPs may find it difficult to have the necessary patient conversations, especially within a short consultation. As with previous letters, these letters will advise GPs of actions that they can take to reduce inappropriate prescribing, supporting them to have conversations with patients, and there will be TARGET leaflets enclosed.

Power calculation All trials are powered to detect a 2% reduction in prescribing at a significance level of 0.05 with a power of 80%.

Statistical analysis plan In order to test our hypotheses, the investigators will use a fixed effects panel regression model, with time trends accounting for seasonal effects, to estimate the effect of treatment status on prescribing. The investigators will also run ANCOVAs for each month separately and one covering the whole six months of the trial. Analysis will control for baseline prescribing rates and for whether practices got the version of the letter saying that their prescribing has been increasing.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

2963

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

• GP practices that prescribed more than 0.919 Antibacterial Items/STAR- PU (5% under the target of 0.965) for the twelve months April 2018 - March 2019

Exclusion Criteria:

• Practices in the 99th percentile of prescribers

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: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Just under target control
Practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing; no letter sent.
Experimental: Just under target letter

Practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing: receive a letter informing of this.

Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter

Letters sent to GPs in relevant practices (prescribing data is by practice, so the practice is the unit of randomization)
Kein Eingriff: Over target control

Practices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; no letter sent

  • Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter B1)
  • Intervention 2: Letter informing them that their practice's prescribing exceeds the new target with a graph representing prescribing relative to the target (Letter B2)
Experimental: Over target letter

Practices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; receive a letter informing them that their practice's prescribing exceeds the new target (Letter B1)

Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter

Letters sent to GPs in relevant practices (prescribing data is by practice, so the practice is the unit of randomization)
Experimental: Over target letter with bar chart

Practices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; receive a letter informing them that their practice's prescribing exceeds the new target, including a bar chart showing their prescribing compared to the target (Letter B1)

Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter

Letters sent to GPs in relevant practices (prescribing data is by practice, so the practice is the unit of randomization)
Aktiver Komparator: Top 20% feedback letter control

Targeting practices that are currently in the top 20% of prescribers; letters informing them of the percentile they are on--standard practice--(Letter C1)

Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter

Letters sent to GPs in relevant practices (prescribing data is by practice, so the practice is the unit of randomization)
Experimental: Top 20% above target letter

Targeting practices that are currently in the top 20% of prescribers; letters informing them that their prescribing exceeds the new target (Letter C2)

Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter.

Letters sent to GPs in relevant practices (prescribing data is by practice, so the practice is the unit of randomization)
Experimental: Top 20% feedback letter with specific example of patient harm

Targeting practices that are currently in the top 20% of prescribers

• Control: Current standard practice, a social norms message, that their practice is in the top 20% of prescribers (Letter C1) Targeting practices that are currently in the top 20% of prescribers; letters informing them of the percentile they are on with a specific example of a case of patient harm caused by antimicrobial resistance (Letter C3)

Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter.

Letters sent to GPs in relevant practices (prescribing data is by practice, so the practice is the unit of randomization)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total antibiotic prescribing in September
Zeitfenster: 1 month
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
1 month
Total antibiotic prescribing in October
Zeitfenster: 2 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
2 months
Total antibiotic prescribing in November
Zeitfenster: 3 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
3 months
Total antibiotic prescribing in December
Zeitfenster: 4 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
4 months
Total antibiotic prescribing in January
Zeitfenster: 5 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
5 months
Total antibiotic prescribing in February
Zeitfenster: 6 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
6 months
Total antibiotic prescribing in from September-February
Zeitfenster: 6 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
6 months
Proportion of practices in each group whose prescribing was under the target
Zeitfenster: 8 months
Whether antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) for April 2019-March 2020 is under the NHS target of 0.965 items per STAR-PU
8 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

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)

31. August 2019

Primärer Abschluss (Tatsächlich)

30. August 2020

Studienabschluss (Tatsächlich)

30. August 2020

Studienanmeldedaten

Zuerst eingereicht

7. August 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. August 2019

Zuerst gepostet (Tatsächlich)

9. August 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. September 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2020

Zuletzt verifiziert

1. September 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • CMO Letter 2019/20

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Note that the trial will use publicly available prescribing data, so any researcher should be able to access it.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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