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

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
Shaun Treweek, University of Dundee
ClinicalTrials.gov Identifier:
NCT01206738
First received: September 21, 2010
Last updated: May 20, 2014
Last verified: May 2014
Results First Received: January 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Antibiotic Prescribing by GPs for URTI.
Interventions: Behavioral: Persuasive communication
Behavioral: Action plan
Behavioral: General intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Note that two studies are listed under this registration: 1) an email vs postal invitation study (with 270 enrolled) and 2) a trial that involved a subset of those involved in the email vs postal invitation study. The trial enrolled 198 participants.

See arm descriptions for further explanation of participant numbers.


Reporting Groups
  Description
Persuasive Communication

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

Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study.

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.

Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study.

General Information

No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care).

Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study.


Participant Flow:   Overall Study
    Persuasive Communication     Alternative Intervention     General Information  
STARTED     63     74     61  
COMPLETED     40     49     42  
NOT COMPLETED     23     25     19  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
GPs across Scotland

Reporting Groups
  Description
Persuasive Communication The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
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.
General Information No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
Total Total of all reporting groups

Baseline Measures
    Persuasive Communication     Alternative Intervention     General Information     Total  
Number of Participants  
[units: participants]
  63     74     61     198  
Age, Customized [1]
[units: years]
Mean ± Standard Deviation
       
Years qualified     22  ± 9     20  ± 9     22  ± 8     21  ± 9  
Gender [2]
[units: participants]
       
Female     27     34     27     88  
Male     35     36     32     103  
Region of Enrollment  
[units: participants]
       
United Kingdom     63     74     61     198  
[1] Age was not collected; we collected years a GP had been qualified
[2] Some participants chose not to respond to the gender question.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Simulated Scenarios Where an Antibiotic Was Not Prescribed   [ Time Frame: Immediately after completion of questionnaire ]

2.  Primary:   Email vs Postal Recruitment: Number of GPs Completing the First Questionnaire   [ Time Frame: 27/1/20111 - 15/5/2011 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof Shaun Treweek
Organization: University of Aberdeen
e-mail: streweek@mac.com


Publications of Results:
Other Publications:

Responsible Party: Shaun Treweek, University of Dundee
ClinicalTrials.gov Identifier: NCT01206738     History of Changes
Other Study ID Numbers: 2010PS10, CZH/4/610
Study First Received: September 21, 2010
Results First Received: January 30, 2014
Last Updated: May 20, 2014
Health Authority: UK: Research Ethics Committee
UK: NHS R&D Offices