Antibiotic Prescribing by GPs for URTIWIMENCT01206738
Developing and Evaluating Interventions to Reduce Inappropriate Prescribing of Antibiotics in Primary Care
A study testing Persuasive communication, Action plan and General intervention in people with Antibiotic Prescribing by GPs for URTI, run by University of Dundee at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antibiotic Prescribing by GPs for URTI
- What is being tested?
- Persuasive communication, Action plan and General intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- GPs in Scotland.
Who cannot join
- Unable to obtain both an email address and a postal address for the GP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Conditions
- Antibiotic Prescribing by GPs for URTI
- Being tested
- Persuasive communication, Action plan, General intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persuasive communicationBehavioural
The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
Action planBehavioural
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
General interventionBehavioural
No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.
| Study group | Role | What they receive |
|---|---|---|
| Persuasive communication | Experimental | The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics. Receives: Behavioral: Persuasive communication |
| Alternative intervention | Experimental | 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 Receives: Behavioral: Action plan |
| General information | Active comparator | No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing. Receives: Behavioral: General intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after completion of questionnaire
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
Measured: 27/1/20111 - 15/5/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Prescribing by GPs for URTIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aberdeen, Newcastle University, University of Southampton, Chief Scientist Office of the Scottish Government, Scottish Primary Care Research Network, Scottish School of Primary Care
- Responsible party
- Principal investigator, Shaun Treweek, University of Dundee
- Investigators
- Shaun Treweek, PhD, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206738
- Sponsor's protocol ID
- 2010PS10
- Other IDs
- CZH/4/610
- Acronym
- WIME
- Status last verified
- May 2017
- First submitted
- 21 Sep 2010
- Last updated
- 2 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There are no patient-level data in this trial because no patients were involved. More information about the study and what was collected can be obtained from the Shaun Treweek at streweek@mac.com.
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.
PubMed 21371323Treweek 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.
PubMed 22306007Treweek 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.
PubMed 24388292Treweek 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.
PubMed 27470610
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01206738
- Acronym / sponsor ID
- WIME / 2010PS10
- Conditions
- Antibiotic Prescribing by GPs for URTI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- University of Aberdeen, Newcastle University, University of Southampton, Chief Scientist Office of the Scottish Government, Scottish Primary Care Research Network, Scottish School of Primary Care
- Study start
- Nov 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Posted 18 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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?
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Persuasive communication | Experimental | Behavioral: Persuasive communicationThe persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics. |
| Alternative intervention | Experimental | Behavioral: Action planThis 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 |
| General information | Active comparator | Behavioral: General interventionNo additional information was provided; the general information was the information already available to GPs about antibiotic prescribing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- GPs in Scotland.
Key exclusion criteria (1 listed)
- Unable to obtain both an email address and a postal address for the GP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Persuasive communicationThe persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics. | Behavioural | Persuasive communication |
| Action planThis 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 | Behavioural | Alternative intervention |
| General interventionNo additional information was provided; the general information was the information already available to GPs about antibiotic prescribing. | Behavioural | General information |
Primary outcome
Number of Simulated Scenarios Where an Antibiotic Was Not Prescribed
Time frame: Immediately after completion of questionnaire
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.
Email vs Postal Recruitment: Number of GPs Completing the First Questionnaire
Time frame: 27/1/20111 - 15/5/2011
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21371323Treweek 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.
- Results publication: PubMed 22306007Treweek 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.
- Results publication: PubMed 24388292Treweek 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.
- Results publication: PubMed 27470610Treweek 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.
- Individual participant dataSharing planned: No. There are no patient-level data in this trial because no patients were involved. More information about the study and what was collected can be obtained from the Shaun Treweek at streweek@mac.com.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaun Treweek, PhD principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Persuasive communication, Action plan and General intervention in people with Antibiotic Prescribing by GPs for URTI, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Simulated Scenarios Where an Antibiotic Was Not Prescribed (time frame: Immediately after completion of questionnaire). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01206738, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.