Effectiveness and safety of electronically delivered prescribing feedback and decision support on antibiotic use for respiratory illness in primary care: REDUCE cluster randomised trialBMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l236 (Published 13 February 2019) Cite this as: BMJ 2019;364:l236
- Martin C Gulliford, professor of public health1 2,
- A Toby Prevost, professor of medical statistics1 2 3,
- Judith Charlton, research associate1,
- Dorota Juszczyk, research associate1 2,
- Jamie Soames, clinical research policy and delivery officer4,
- Lisa McDermott, research associate1,
- Kirin Sultana, clinical trial configuration manager4,
- Mark Wright, head of real world clinical studies4,
- Robin Fox, general practitioner5,
- Alastair D Hay, professor of primary care6,
- Paul Little, professor of primary care research7,
- Michael V Moore, professor of primary health care research7,
- Lucy Yardley, professor of health psychology8 9,
- Mark Ashworth, reader in general practice1
- 1School of Population Health and Environmental Sciences, King’s College London, Guy’s Campus, King’s College London, London, UK
- 2NIHR Biomedical Research Centre at Guy’s and St Thomas’ Hospitals London, London, UK
- 3School of Public Health, Imperial College London, London, UK
- 4Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK
- 5The Health Centre, Bicester, Oxfordshire, UK
- 6Centre for Academic Primary Care, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
- 7Primary Care Research Group, University of Southampton, Southampton, UK
- 8Department of Psychology, University of Southampton, Southampton, UK
- 9School of Psychological Science, University of Bristol, Bristol, UK
- Correspondence to: M C Gulliford, Addison House, Guy’s Campus, King’s College London, London SE1 1UL, UK
- Accepted 31 December 2018
Objectives To evaluate the effectiveness and safety at population scale of electronically delivered prescribing feedback and decision support interventions at reducing antibiotic prescribing for self limiting respiratory tract infections.
Design Open label, two arm, cluster randomised controlled trial.
Setting UK general practices in the Clinical Practice Research Datalink, randomised between 11 November 2015 and 9 August 2016, with final follow-up on 9 August 2017.
Participants 79 general practices (582 675 patient years) randomised (1:1) to antimicrobial stewardship (AMS) intervention or usual care.
Interventions AMS intervention comprised a brief training webinar, automated monthly feedback reports of antibiotic prescribing, and electronic decision support tools to inform appropriate prescribing over 12 months. Intervention components were delivered electronically, supported by a local practice champion nominated for the trial.
Main outcome measures Primary outcome was the rate of antibiotic prescriptions for respiratory tract infections from electronic health records. Serious bacterial complications were evaluated for safety. Analysis was by Poisson regression with general practice as a random effect, adjusting for covariates. Prespecified subgroup analyses by age group were reported.
Results The trial included 41 AMS practices (323 155 patient years) and 38 usual care practices (259 520 patient years). Unadjusted and adjusted rate ratios for antibiotic prescribing were 0.89 (95% confidence interval 0.68 to 1.16) and 0.88 (0.78 to 0.99, P=0.04), respectively, with prescribing rates of 98.7 per 1000 patient years for AMS (31 907 prescriptions) and 107.6 per 1000 patient years for usual care (27 923 prescriptions). Antibiotic prescribing was reduced most in adults aged 15-84 years (adjusted rate ratio 0.84, 95% confidence interval 0.75 to 0.95), with one antibiotic prescription per year avoided for every 62 patients (95% confidence interval 40 to 200). There was no evidence of effect for children younger than 15 years (adjusted rate ratio 0.96, 95% confidence interval 0.82 to 1.12) or people aged 85 years and older (0.97, 0.79 to 1.18); there was also no evidence of an increase in serious bacterial complications (0.92, 0.74 to 1.13).
Conclusions Electronically delivered interventions, integrated into practice workflow, result in moderate reductions of antibiotic prescribing for respiratory tract infections in adults, which are likely to be of importance for public health. Antibiotic prescribing to very young or old patients requires further evaluation.
Trial registration ISRCTN95232781.
Contributors: MCG contributed to the trial design, conduct, and analysis; ATP contributed to the trial design, statistical analysis plan, and statistical advice; JC contributed to the intervention delivery and trial analysis; DJ, LM, and LY contributed to the design of the interventions and evaluation; JS, KS, and MW contributed to the recruitment and coordination of trial; and RF, ADH, PL, MVM, and MA contributed to the design of the study, intervention development, and interpretation of results. All authors contributed to and approved the final manuscript. The authors had full access to all the data in the study and all authors shared final responsibility for the decision to submit for publication. MG is guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Trial steering committee: Jackie Cassell (chair), Susan Hopkins (Public Health England), Tim Chadborn (Public Health England), Nanik Pursani (lay member). Data monitoring committee: Christine A’Court (chair), Helen Strongman (CPRD/MHRA), Derek Cook (St George’s, University of London), Jason Oke (University of Oxford).
Funding: Funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (13/88/10). MCG was supported by the NIHR Biomedical Research Centre at Guy’s and St Thomas’ Hospitals. The views expressed are those of the authors and not necessarily those of the NHS, NIHR, or UK Department of Health. The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the NIHR for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The protocol was approved by the NHS London-Dulwich research ethics committee (14/LO/1730) and by the CPRD independent scientific advisory committee (ISAC 14_130). Trial oversight was provided by independent trial steering and data monitoring committees. Each participating general practice gave written informed consent for participation.
Data sharing: Requests for access to data from the study should be addressed to the corresponding author at. The study protocol has been published. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of the trial co-investigator team, and CPRD before data release.
The lead author affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
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