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Developing and Evaluating Interventions to Reduce Inappropriate Prescribing of Antibiotics in Primary Care

Developing and Evaluating Interventions to Reduce Inappropriate Prescribing by General Practitioners of Antibiotics for Upper Respiratory Tract Infections: an RCT to Compare Paper-based and Web-based Modelling Experiments

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01206738
Acronym
WIME
Enrollment
270
Registered
2010-09-22
Start date
2010-11-30
Completion date
2012-09-30
Last updated
2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Prescribing by GPs for URTI

Brief summary

1. Do paper-based and web-based intervention modelling experiments (the methodology we are developing) identify the same predictors of GP behaviour regarding prescribing of antibiotics for upper respiratory tract infections? 2. Can a web-based IME system provide trialists with richer and more predictive information upon which to base the development of behavioural change interventions than paper-based IME systems?

Detailed description

The NHS needs effective quality improvement interventions to be put into clinical practice, which requires effective behaviour change interventions. Intervention modelling experiments (IMEs) are a way of exploring and refining an intervention before moving to a full-scale trial. They do this by delivering key elements of the intervention in a simulation that approximates clinical practice by, for example, presenting GPs with a clinical scenario about making a treatment decision. Earlier IMEs have been paper-based, which limits what can be done in the simulation. Web-based IMEs provide the potential for better clinical simulations, which have the potential to lead to better interventions. The current proposal will run a full, web-based IME involving 250 GPs that will advance the methodology of IMEs by directly comparing results with an earlier paper-based IME. Moreover, the web-based IME will evaluate an intervention that can be put into a full-scale trial that aims to reduce antibiotic prescribing in primary care. Reducing inappropriate prescribing of antibiotics in general practice is a national priority; indeed, antibiotic use is increasing in the UK and Scotland's prescribing is second highest amongst UK administrations. More effective behaviour change interventions are needed and this proposal will develop one such intervention and a system to model and test future interventions. This system will be applicable to any situation in the NHS where behaviour needs to be modified, including interventions aimed directly at the public.

Interventions

BEHAVIORALPersuasive communication

The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.

BEHAVIORALAction plan

This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic

BEHAVIORALGeneral intervention

No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.

Sponsors

University of Aberdeen
CollaboratorOTHER
Newcastle University
CollaboratorOTHER
University of Southampton
CollaboratorOTHER
Chief Scientist Office of the Scottish Government
CollaboratorOTHER_GOV
Scottish Primary Care Research Network
CollaboratorUNKNOWN
Scottish School of Primary Care
CollaboratorUNKNOWN
University of Dundee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* GPs in Scotland.

Exclusion criteria

* Unable to obtain both an email address and a postal address for the GP.

Design outcomes

Primary

MeasureTime frameDescription
Number of Simulated Scenarios Where an Antibiotic Was Not PrescribedImmediately after completion of questionnaireEight simulated clinical scenarios where presented to the GP and he/she was asked whether an antibiotic should be prescribed. The outcome measures was the number of scenarios where an antibiotic was not prescribed.
Email vs Postal Recruitment: Number of GPs Completing the First Questionnaire27/1/20111 - 15/5/2011GPs were randomly allocated to receive their invitation to take part by email or by post. Outcome measure was proportion of GPs responding by completing the first questionnaire

Countries

United Kingdom

Participant flow

Recruitment details

For email vs postal study, 880 physicians received email and 880 received postal invitations. 138 and 132 responded respectively. Other recruitment data presented below are for the main trial component, which involved a subset of the 270 (ie. 138+132) responding to the initial invitation. See arm descriptions for further explanation.

Pre-assignment details

Note this study has two parts: 1) an email vs postal invitation study (with 270 enrolled) and 2) a trial involving a subset (172) of those involved in the email vs postal invitation study. The trial enrolled 198 participants in total, with 26 participants not being involved in the email study. See arm descriptions for further explanations.

Participants by arm

ArmCount
Persuasive Communication
The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
63
Alternative Intervention
Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
74
General Information
No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
61
Total198

Baseline characteristics

CharacteristicPersuasive CommunicationAlternative InterventionGeneral InformationTotal
Age, Customized
Years qualified
22 years
STANDARD_DEVIATION 9
20 years
STANDARD_DEVIATION 9
22 years
STANDARD_DEVIATION 8
21 years
STANDARD_DEVIATION 9
Region of Enrollment
United Kingdom
63 participants74 participants61 participants198 participants
Sex/Gender, Customized
Female
27 participants34 participants27 participants88 participants
Sex/Gender, Customized
Male
35 participants36 participants32 participants103 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

Email vs Postal Recruitment: Number of GPs Completing the First Questionnaire

GPs were randomly allocated to receive their invitation to take part by email or by post. Outcome measure was proportion of GPs responding by completing the first questionnaire

Time frame: 27/1/20111 - 15/5/2011

Population: 880 physicians received email and 880 received postal invitations. 138 and 132 responded respectively.

ArmMeasureValue (NUMBER)
Persuasive CommunicationEmail vs Postal Recruitment: Number of GPs Completing the First Questionnaire138 participants
Alternative InterventionEmail vs Postal Recruitment: Number of GPs Completing the First Questionnaire132 participants
Primary

Number of Simulated Scenarios Where an Antibiotic Was Not Prescribed

Eight simulated clinical scenarios where presented to the GP and he/she was asked whether an antibiotic should be prescribed. The outcome measures was the number of scenarios where an antibiotic was not prescribed.

Time frame: Immediately after completion of questionnaire

ArmMeasureValue (MEAN)Dispersion
Persuasive CommunicationNumber of Simulated Scenarios Where an Antibiotic Was Not Prescribed5 scenariosStandard Deviation 1.4
Alternative InterventionNumber of Simulated Scenarios Where an Antibiotic Was Not Prescribed5 scenariosStandard Deviation 1.6
General InformationNumber of Simulated Scenarios Where an Antibiotic Was Not Prescribed4.2 scenariosStandard Deviation 1.1

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026