- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01206738
Developing and Evaluating Interventions to Reduce Inappropriate Prescribing of Antibiotics in Primary Care (WIME)
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
- 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?
- 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?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tayside
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Dundee, Tayside, United Kingdom, DD1 4HN
- University of Dundee
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- GPs in Scotland.
Exclusion Criteria:
- Unable to obtain both an email address and a postal address for the GP.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Persuasive communication
The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
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The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
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Experimental: Alternative intervention
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
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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
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Active Comparator: General information
No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.
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No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Simulated Scenarios Where an Antibiotic Was Not Prescribed
Time Frame: Immediately after completion of questionnaire
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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.
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Immediately after completion of questionnaire
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Email vs Postal Recruitment: Number of GPs Completing the First Questionnaire
Time Frame: 27/1/20111 - 15/5/2011
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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
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27/1/20111 - 15/5/2011
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shaun Treweek, PhD, University of Dundee
Publications and helpful links
General Publications
- Treweek S, Ricketts IW, Francis J, Eccles M, Bonetti D, Pitts NB, Maclennan G, Sullivan F, Jones C, Weal M, Barnett K. Developing and evaluating interventions to reduce inappropriate prescribing by general practitioners of antibiotics for upper respiratory tract infections: a randomised controlled trial to compare paper-based and web-based modelling experiments. Implement Sci. 2011 Mar 3;6:16. doi: 10.1186/1748-5908-6-16.
- Treweek S, Barnett K, Maclennan G, Bonetti D, Eccles MP, Francis JJ, Jones C, Pitts NB, Ricketts IW, Weal M, Sullivan F. E-mail invitations to general practitioners were as effective as postal invitations and were more efficient. J Clin Epidemiol. 2012 Jul;65(7):793-7. doi: 10.1016/j.jclinepi.2011.11.010. Epub 2012 Feb 4.
- Treweek S, Bonetti D, Maclennan G, Barnett K, Eccles MP, Jones C, Pitts NB, Ricketts IW, Sullivan F, Weal M, Francis JJ. Paper-based and web-based intervention modeling experiments identified the same predictors of general practitioners' antibiotic-prescribing behavior. J Clin Epidemiol. 2014 Mar;67(3):296-304. doi: 10.1016/j.jclinepi.2013.09.015. Epub 2013 Dec 31.
- Treweek S, Francis JJ, Bonetti D, Barnett K, Eccles MP, Hudson J, Jones C, Pitts NB, Ricketts IW, Sullivan F, Weal M, MacLennan G. A primary care Web-based Intervention Modeling Experiment replicated behavior changes seen in earlier paper-based experiment. J Clin Epidemiol. 2016 Dec;80:116-122. doi: 10.1016/j.jclinepi.2016.07.008. Epub 2016 Jul 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2010PS10
- CZH/4/610 (Other Grant/Funding Number: Chief Scientist Office)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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