EUROPE Antimicrobial stewardship The effectiveness of educational interventions to change risk-related behaviours in the general population A systematic review Sarah King, Josephine Exley, Jirka Taylor, Kristy Kruithof, Jody Larkin, Mafalda Pardal For more information on this publication, visit www.rand.org/t/RR1066 Published by the RAND Corporation, Santa Monica, Calif., and Cambridge, UK R ® is a registered trademark. © Copyright 2015 NICE RAND Europe is an independent, not-for-profit policy research organisation that aims to improve policy and decisionmaking in the public interest through research and analysis. RAND’s publications do not necessarily reflect the opinions of its research clients and sponsors. All rights reserved. No part of this book may be reproduced in any form by any electronic or mechanical means (including photocopying, recording, or information storage and retrieval) without permission in writing from the sponsor. Support RAND Make a tax-deductible charitable contribution at www.rand.org/giving/contribute www.rand.org www.rand.org/randeurope Preface The National Institute for Health and Care Excellence (NICE) has been asked by the Department of Health to develop a public health guideline aimed at delaying antimicrobial resistance, which will focus on educating the public about:  The importance of the appropriate use of antimicrobials;  The dangers associated with the overuse and misuse of antimicrobials; and  Changes in behaviour that can be taken to avert threats associated with the misuse of these drugs, such as infection prevention measures. To inform this guidance, RAND Europe was commissioned to undertake a systematic review of the evidence of effectiveness and cost-effectiveness of changing the public’s risk related behaviours pertaining to antimicrobial use to inform the development of the guidelines. In particular the review sought to answer two research questions: 1. Which educational interventions are effective and cost-effective in changing people’s behaviour to ensure they only ask for antimicrobials when appropriate and use them correctly? 2. Which educational interventions are effective and cost-effective in changing the public’s behaviour to prevent infection and reduce the spread of antimicrobial resistance? In addressing these questions this technical report of our systematic review provides a detailed summary and quality assessment of the available evidence published since 2001, intended to inform the Public Health Advisory Committee (PHAC) tasked with formulating the guideline. The evidence from this review is presented in a series of concise Evidence Statements in adherence with NICE guidance. Each statement provides a high level overview of the key features of the evidence including the number of studies, the quality of evidence and the direction of the estimated effect followed by a brief summary of each of the supporting studies. RAND Europe is an independent not-for-profit policy research organisation that aims to improve policy- and decision-making in the public interest, through research and analysis. This report has been peer- reviewed in accordance with RAND’s quality assurance standards. For more information about this document or RAND Europe, please contact: Dr Sarah King RAND Europe Westbrook Centre, Milton Road, Cambridge, CB4 1YG Tel: +44 (0)1223 353 329 email: [email protected] i Summary Antimicrobial drugs include antibiotics, antivirals and antifungals which are used to kill microorganisms such as bacteria and viruses. The availability of effective antimicrobial drugs are estimated to add 20 years to life expectancy. The emergence of antimicrobial resistance (AMR) therefore poses a serious threat to public health. AMR is the ability of microorganisms to continue to multiply uninhibitedly in the presence of antimicrobial drugs, making conventional treatment ineffective. AMR poses a growing threat to public health, as infections from resistant strains of microbials become increasingly difficult and expensive to treat, resulting in prolonged illness and greater risk of death. The over use and inappropriate use of antimicrobials contribute to the acceleration, emergence and spread of AMR. Strategies that encourage antimicrobials to be used more responsibly and less often are therefore needed to safeguard human health. This includes awareness campaigns targeting the public to raise the profile of the issue and induce societal and cultural change. RAND Europe was commissioned by NICE Centre for Public Health to conduct a systematic review of the effectiveness and cost-effectiveness of educational interventions aimed at changing risk-related behaviours relating to the use of antimicrobials. This evidence will be used to help inform the development of a guideline aimed at delaying antimicrobial resistance. This review considered educational interventions targeting individuals, communities or the general public delivered via any number of modes (e.g. classroom education, leaflets, campaigns). Specifically, this review aimed to answer the following research questions: 1. Which educational interventions are effective and cost-effective in changing the public’s behaviour to ensure they only ask for antimicrobials when appropriate and use them correctly? 2. Which educational interventions are effective and cost-effective in changing the public’s behaviour to prevent infection and reduce the spread of antimicrobial resistance? This review did not include interventions targeting physicians or other prescribers, as this is the focus of another NICE review conducted in parallel to this one (Antimicrobial stewardship: systems and processes for effective antimicrobial medicine use: http://www.nice.org.uk/guidance/indevelopment/gid- antimicrobialstewardship). The review was conducted following guidance presented in ‘Developing NICE guidelines: the manual’. A range of relevant databases were searched for data from 2001 onwards. Given that interventions, settings, and population groups differed in the included studies, meta-analyses were not conducted, and the results were summarised narratively in texts and tables. iii Overall, 60 studies met the inclusion criteria; 29 of these related to research question 1, and 36 related to research question 2 (5 studies were applicable to both research questions). The results for research question 2 were subdivided into studies related to infection and/or hand hygiene (22 studies) and food safety and hygiene (16 studies). Some studies reported on multiple relevant outcomes and are reported in each relevant section. Twelve studies were rated as moderate quality (+), and the remaining 48 studies were rated as poor quality (-), based on a methodology checklist published by NICE for public health guidance. The key findings from these studies are briefly summarised below in ‘Evidence Statements’, which are statements that provide a high level overview of the key features of the evidence, including the number of studies, the quality of evidence, and the direction of the estimated effect followed by a brief summary of each of the supporting studies. Studies have been grouped into Evidence Statements by setting and intervention. For a more detailed overview of the individual studies the reader should refer to the written narrative within the body of the report. iv Research question 1: Antibiotic knowledge and behaviour Pharmacist – led interventions targeting patients or carers of patients Evidence Statement 1.1 Pharmacist-led verbal education, supplemented with an information leaflet There is weak evidence from one non-randomised controlled trial (non-RCT) (-)1, one randomised controlled trial (RCT) (-)2 and one pre–post study (-)3 indicating that verbal education on antibiotic adherence from a pharmacist, or the combination of written and verbal education on antimicrobial (AM) use and antimicrobial resistance (AMR) delivered by pharmacists, can improve patients’ adherence to treatment and knowledge of AM use, but that written and verbal education did not increase awareness of AMR. However, baseline awareness was high, potentially leaving less room for knowledge gain. One non-RCT1 (-) (Spain; n=138) found that individualised verbal education about treatment characteristics, duration, dosage regime and how to use the antibiotic delivered by a pharmacist to patients and/or carers before collecting an antibiotic prescription, lead to increased adherence (aOR 2.23 [95%CI: 1.01 to 4.93] p=0.047). One RCT2 (-) (Australia; n=34) found that the provision of a patient education leaflet plus verbal education from a pharmacist led to improved knowledge of antibiotics (the mean difference in ‘antibiotic knowledge’ score increased by 33.3% (±40.8), from 60.0% (±43.9) to 86.6% (±17.2) (p=0.008). Conversely, in the control group (who received a ‘Consumer Medicines Information’ leaflet only), there was a non-significant decrease in knowledge of antibiotics; the mean difference in ‘antibiotic knowledge’ score decreased from 83.3% (±23.6) to 80.0% (±35.8) (p=non-significant (ns)). No statistical comparisons were made between the control and intervention groups. One pre–post study3 (-) (USA; n=130) reported that pharmacist-led verbal education and a patient educational leaflet and handout significantly improved patients’ overall understanding of AMR, from 56.5% at baseline to 78.3% at follow up (p=0.026). However, the change-from-baseline for all three individual component questions/statements was non-significant, potentially because baseline knowledge of the participants was already high. The results also indicated some improvements in patients’ understanding of the appropriate use of antibiotics. There was a significant increase in the number of patients who correctly reported that antibiotics should not be used to treat viral infections for two out of the four conditions surveyed: cold, from 58.7% to 80.4% (p=0.02), and flu with body aches, from 34.8% to 60.9% (p=0.02). Applicability: While none of the studies were conducted in the UK, the evidence is directly applicable to people in the UK as there are no obvious differences in the population, context or setting of the studies compared with the UK context. 1. Muñoz et al. 2013 (-) 2. Northey et al. 2010 (-) 3. Rodis et al. 2004 (-) v Interventions based in general practice and/or led by a GP targeting patients or parents of paediatric patients Evidence Statement 1.2 Video- and information leaflet–based interventions in general practice and/or led by a GP targeting parents of paediatric patients There is weak evidence from two RCTs (+)1 (-)2 and one non-RCT (-)3 that the combination of an educational video on antimicrobial use and antimicrobial resistance, supplemented by an information leaflet delivered within a primary care setting, can improve parents’ knowledge of appropriate antimicrobial use and expectations of antimicrobials for their child, but that it was not effective in improving awareness of AMR. One RCT1 (+) (USA; n=206) found that a 20-minute video programme, supplemented by an information leaflet, both of which aimed to educate parents on the problem of bacterial resistance to antibiotics and their appropriate use to prevent the development of resistance, did not have an impact on knowledge scores or any of the five statements related to beliefs, but did have a significant impact on one of the five behaviour statements: there was a reduction in saving antibiotics for later use when compared with the control group, 3.82 vs 3.62 (p=0.02). One RCT2 (-) (USA; n=499) conducted in a paediatrician’s office reported that an information leaflet (‘Your Child and Antibiotics’) and a video presented by a GP on judicious use of antibiotics was effective in increasing parents’ knowledge of when to use antibiotics for all five statements related to appropriate use of antibiotics for specific conditions in children compared with control, but for only one out of the five more general statements related to increasing awareness of AMR. One non-RCT3 (-) (USA; n=771) conducted in a GP’s office found that provision of an information leaflet (‘Your Child and Antibiotics’) and a video in waiting rooms significantly improved knowledge of when to take antibiotics in those who reported seeing the video vs those who reported not seeing the video at 36 weeks post-intervention: 7.1% vs 29.2% thought that antibiotics should be used to treat a child with fever or a cold (p≤0.001), and 13.8% vs 44.3% wanted/expected the doctor to prescribe antibiotics for their child (p<0.001). Applicability: While none of the studies were conducted in the UK, the evidence is directly applicable to people in the UK, despite differences in the broader healthcare context in the USA, as there are no obvious differences in the population, context or setting of the study compared with the UK context. 1. Bauchner et al. 2001 (+) 2. Taylor et al. 2003 (-) 3. Wheeler et al. 2001 (-) vi Evidence Statement 1.3 Communication and/or information leaflet-based interventions in general practice targeting parents of paediatric patients There is inconsistent evidence from one RCT(-)1 and one cluster-RCT (+)2 on the effectiveness of educational interventions that aim to improve patient doctor dialogue during a GP consultation, supplemented by an information leaflet, on parents expectation of antibiotic treatment or ‘intention to consult’, but there was significant reduction in antibiotic consumption. One RCT (-)1 (USA; n=80) found that an intervention to enhance communication between parents and their child’s physician (involving role play) and/or an information leaflet (‘Your Child and Antibiotics’), plus a fact sheet about antibiotics and AMR, did not significantly change parents’ expectations of antibiotic treatment for their child compared with the control group, who were given information on child nutrition. We note that the results were not clearly presented and that therefore no clear data can be presented here. One cluster-RCT2 (+) (England and Wales; n=558 children) found that online training for GPs in combination with a booklet, designed to be used as a consultation aid (to increase doctor/patient communication) and a take home resource for parents, led to significant reductions in antibiotic consumption (22.4% in intervention vs. 43% in control; aOR [95% CI 0.18 to 0.66]) and parents’ intention ‘to consult if their child had a similar illness’ (55.3% in intervention vs. 76.4% in control; aOR 0.34 [95%CI 0.20 to 0.57]). Applicability: While one of the studies was not conducted in the UK, the evidence is directly applicable to people in the UK, despite differences in the broader healthcare context in the USA, as there are no obvious differences in the population, context or setting of the study compared with the UK context. 1. Alder et al. 2005 (-) 2. Francis et al. 2009 (+) Evidence Statement 1.4 Cold pack and information leaflet–based intervention in general practice led by a GP targeting adult patients There is weak evidence from one non-RCT (-)1 (USA; n=299 analysed) that an information leaflet (‘Antibiotics – Did You Know?’) distributed in a primary care setting to all participating adult patients, significantly decreased the patients’ perceived need for antibiotics at post-test follow up (p<0.001 [pre vs. post for all participants]) and increased their knowledge of appropriate antibiotic use (i.e. for what illnesses one should take antibiotics) (p<0.034 [pre-vs. post for all participants]). A sub-sample of patients were allocated a cold pack which contained products designed to provide symptomatic relief, and sub- group analysis revealed that an increase in appropriate antibiotic use knowledge was significantly larger for the education group (p<0.002), but not for those who received both education and a ‘cold pack’ kit. Applicability: While the study was not conducted in the UK, the evidence is directly applicable to people in the UK as there are no obvious differences in the population, context or setting of the study compared with the UK vii context. 1. Alden et al. 2010 (-) Evidence Statement 1.5 Information leaflet (with or without delayed prescription) targeting patients There is inconsistent evidence from one RCT (-)1 and one nested-RCT (+)2 on the effectiveness of information leaflets within a primary care setting to reduce antibiotic use in patients with lower respiratory tract infections. One RCT (-)1 (UK; n=807) conducted in a primary care setting found that providing patients (with acute lower respiratory tract infection) with an information leaflet about the natural history of the condition, had no significant effect on antibiotic use (p=0.58), satisfaction with treatment (p=0.24) or belief in antibiotics (p=0.73) when compared to no leaflet. Patients in this study were also randomised to receive no prescription, delayed prescription or immediate prescription, but leaflet vs. no leaflet results were not presented within each of these prescribing practices. One nested-RCT2 (+) (UK; n=212) found that an information leaflet about the natural course of lower respiratory tract symptoms and the advantages/disadvantages of antibiotic use provided to patients with acute bronchitis who were judged by their GP not to need antibiotics but given a prescription with the advice that they did not need it, significantly reduced inappropriate antibiotic use. Patients in the intervention were significantly less likely to take the antibiotics prescribed compared with patients in the control, who received standard care (RR 0.76 [95%CI: 0.59 to 0.97], p=0.04). Applicability: While one of the studies was not conducted in the UK, the evidence is directly applicable to people in the UK as there are no obvious differences in the population, context or setting of the study compared with the UK context. 1. Little et al. 2005 (-) 2. Macfarlane et al. 2002 (+) viii