By Leah Jones, Research Assistant, Primary Care Unit Public Health England

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A modified McNulty-Zelen design randomised controlled trial to evaluate the TARGET Antibiotics toolkit (Treat Antibiotics Responsibly, Guidance, Education, Tools) and its implementation By Leah Jones, Research Assistant, Primary Care Unit Public Health England Public Health England Dr Cliodna McNulty Leah Ffion Jones Meredith K.D. Hawking Rebecca Owens Dr Donna Lecky Institute of Primary Care & Public Health, Cardiff University School of Medicine, Dr Nick Francis, General Practitioner Dr Micaela Gal Nuffield Department of Primary Gloucester Royal Hospital Care Health Sciences, University of Dr Philippa Moore, Oxford, Consultant Medical Dr Chris Butler, General Practitioner Microbiologist

Background What is the TARGET Antibiotics Toolkit? 2

2014 3

Aims and objectives v To evaluate the TARGET workshop using an RCT design v Does the addition of a face to face one hour TARGET workshop given by local providers result in more appropriate antibiotic prescriptions compared to controls with usual local AMS support? 4

Methods v Modified McNulty-Zelen design: v Practices did not know they were in a trial v Consent given by CCG AMS lead v Practices stratified by antibiotic use and randomised v Practices able to refuse any part of the intervention v Practices in the same building randomised together 5

Methods 152 practices from 4 CCGs in England 77 intervention practices 75 control practices 40 accepted TARGET workshops Received usual CCG support 37 declined TOTAL attending workshops = 318 GP staff (166 GPs, 51 Nurses, 101 Other) 6

Methods 10 9 8 7 6 5 4 3 2 1 0 Pre intervention period 40 Workshop dates and data time frames Coastal West Sussex Oldham Swindon Gloucestershire Post intervention period Quality Premium introduced 7

Workshop immediate feedback (N = 269) The workshop helped them to understand: Why responsible antimicrobial prescribing was an important issue How they could optimise their antimicrobial prescribing 0% 20% 40% 60% 80% 100% 8

Antibiotic data analysis v Data from CIDSC IM&T department for 32 months January 2013 July 2015 v Outcome variable: number of antibiotic or antibiotic group items prescribed each month in each GP practice v Factors included in model: calendar month, GP prescribing rate pre 2013, GP list size, unplanned workshop, other interventions (QP/CMO letter post 04/15) 9

Results Estimated prescribing rate ratio (PRR) comparing all intervention practices compared to controls from Intention To Treat and CACE analyses. Intention to treat Analysis CACE (Complier-Average Causal Effect) PRR (95% CI) P PRR (CI) P All 0.973 (0.945 to 1.001) 0.06 0.939 (0.883 to 0.998) 0.04 antibacterials Amoxicillin 0.956 (0.920 to 0.994) 0.02 0.924 (0.839 to 1.017) 0.11 Co-Amoxiclav 0.969 (0.891 to 1.054) 0.46 0.945 (0.778 to 1.148) 0.57 Trimethoprim 0.944 (0.898 to 0.993) 0.03 0.890 (0.805 to 0.984) 0.02 Nitrofurantoin 1.071 (0.997 to 1.150) 0.06 1.116 (0.964 to 1.293) 0.14 Pivmecillinam 1.611 (0.852 to 3.046) 0.14 model not converging 10 www.rcgp.org.uk/targetantibiotics

Results Total antibacterial prescribing CACE analysis indicated total antibacterials significantly decreased in intervention Analysis Intention to treat CACE (Complier-Average Causal Effect) PRR (95% CI) P PRR (CI) P All antibacterials 0.973 (0.945 to 1.001) 2.7% 0.06 0.939 (0.883 to 0.998) 6.1% 0.04 11

Results Amoxicillin and Ampicillin Significant reduction in Amoxicillin/ampicillin in workshop group Intention to treat Analysis CACE (Complier-Average Causal Effect) PRR (95% CI) P PRR (CI) P Amoxicillin 0.956 (0.920 to 0.994) 4.4% 0.02 0.924 (0.839 to 1.017) 7.6% 0.11 12

Results Nitrofurantoin, Trimethoprim and Pivmecillinam Significant reduction in Trimethoprim for the workshop group Non-significant increase in mecillinam and Nitrofurantoin in workshop group Intention to treat Analysis CACE (Complier-Average Causal Effect) PRR (95% CI) P PRR (CI) P Trimethoprim 0.944 (0.898 to 0.993) 5.6% Nitrofurantoin 1.071 (0.997 to 1.150) 7.1% Pivmecillinam 1.611 (0.852 to 3.046) 61% 0.03 0.890 (0.805 to 0.984) 11% 0.06 1.116 (0.964 to 1.293) 11.6% 0.14 model not converging 0.02 0.14 13

Results Co-amoxiclav Non-significant decrease in Co-amoxiclav in workshop group Intention to treat Analysis CACE (Complier-Average Causal Effect) PRR (95% CI) P PRR (CI) P Co-Amoxiclav 0.969 (0.891 to 1.054) 3.1% 0.46 0.945 (0.778 to 1.148) 5.5% 0.57 14

Conclusions Workshops led to a significant: Decrease in amoxicillin and ampicillin Decrease in overall prescribing in the CACE analysis Decrease in trimethoprim Workshops were well received and increased intentions to prescribe well Design considerations: Were the workshop practices keener? This is a real life example of intervention implementation Use of the TARGET Antibiotics Toolkit should be encouraged 15

www.rcgp.org.uk/targetantibiotics Acknowledgements All of the GPs and stakeholders that took part, Marie-Jet Bekkers, Graham Tanner, Philippa Moore, Alison West, Anita Sharma, Tariq Sharif, Ivor Cartmill, Adam Simon, Thomas Daines, Sue Carter, Paul Clarke, Jen Whibley, Julie Sadler, Gloria Omisakin, Sarah Clarke and Paul Wilson. 16