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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01206738
Other study ID # 2010PS10
Secondary ID CZH/4/610
Status Completed
Phase N/A
First received September 21, 2010
Last updated July 22, 2014
Start date November 2010
Est. completion date September 2012

Study information

Verified date July 2014
Source University of Dundee
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
Study type Interventional

Clinical 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. 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date September 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- GPs in Scotland.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Persuasive communication
The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
Action 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
General intervention
No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.

Locations

Country Name City State
United Kingdom University of Dundee Dundee Tayside

Sponsors (7)

Lead Sponsor Collaborator
University of Dundee Chief Scientist Office of the Scottish Government, Newcastle University, Scottish Primary Care Research Network, Scottish School of Primary Care, University of Aberdeen, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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 Ju — View Citation

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-prescr — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. Immediately after completion of questionnaire No
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 27/1/20111 - 15/5/2011 No