- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03862794
CMO Letter to Reduce Unnecessary Antibiotic Prescribing and Broad Spectrum Prescribing Winter 2018-9 (CMO2018-9)
2. marts 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
7000
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
London, Det Forenede Kongerige, SE1
- Public Health England
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Aktiv 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
|
|
Eksperimentel: 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
|
|
Aktiv 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
|
|
Eksperimentel: 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
|
|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
total antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) in November for each GP practice
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 2 months
|
2 months
|
|
|
percentage broad spectrum antibiotic prescribing in December for each GP practice
Tidsramme: 2 months
|
2 months
|
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice
Tidsramme: 2 months
|
2 months
|
|
|
total antibiotic prescribing in January weighted by STAR-PU for each GP practice
Tidsramme: 3 months
|
3 months
|
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice
Tidsramme: 3 months
|
3 months
|
|
|
percentage broad spectrum antibiotic prescribing in January for each GP practice
Tidsramme: 3 months
|
3 months
|
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice
Tidsramme: 3 months
|
3 months
|
|
|
total antibiotic prescribing weighted by STAR-PU in February for each GP practice
Tidsramme: 4 months
|
4 months
|
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice
Tidsramme: 4 months
|
4 months
|
|
|
percentage broad spectrum antibiotic prescribing in February for each GP practice
Tidsramme: 4 months
|
4 months
|
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice
Tidsramme: 4 months
|
4 months
|
|
|
total antibiotic prescribing weighted by STAR-PU in March for each GP practice
Tidsramme: 5 months
|
5 months
|
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice
Tidsramme: 5 months
|
5 months
|
|
|
percentage broad spectrum antibiotic prescribing in March for each GP practice
Tidsramme: 5 months
|
5 months
|
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice
Tidsramme: 5 months
|
5 months
|
|
|
total antibiotic prescribing weighted by STAR-PU in April for each GP practice
Tidsramme: 6 months
|
6 months
|
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice
Tidsramme: 6 months
|
6 months
|
|
|
percentage broad spectrum antibiotic prescribing in April for each GP practice
Tidsramme: 6 months
|
6 months
|
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2018
Primær færdiggørelse (Faktiske)
30. april 2019
Studieafslutning (Faktiske)
30. maj 2019
Datoer for studieregistrering
Først indsendt
27. februar 2019
Først indsendt, der opfyldte QC-kriterier
1. marts 2019
Først opslået (Faktiske)
5. marts 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. marts 2020
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- R&D 193
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