Dataset Information

Feasibility cluster randomised controlled trial of a within-consultation intervention to reduce antibiotic prescribing for children presenting to primary care with acute respiratory tract infection and cough.

ABSTRACT:

Objective

To investigate recruitment and retention, data collection methods and the acceptability of a 'within-consultation' complex intervention designed to reduce antibiotic prescribing.

Design

Primary care feasibility cluster randomised controlled trial.

Setting

32 general practices in South West England recruiting children from October 2014 to April 2015.

Participants

Children (aged 3 months to <12 years) with acute cough and respiratory tract infection (RTI).

Intervention

A web-based clinician-focussed clinical rule to predict risk of future hospitalisation and a printed leaflet with individualised child health information for carers, safety-netting advice and a treatment decision record.

Controls

Usual practice, with clinicians recording data on symptoms, signs and treatment decisions.

Results

Of 542 children invited, 501 (92.4%) consented to participate, a month ahead of schedule. Antibiotic prescribing data were collected for all children, follow-up data for 495 (98.8%) and the National Health Service resource use data for 494 (98.6%). The overall antibiotic prescribing rates for children's RTIs were 25% and 15.8% (p=0.018) in intervention and control groups, respectively. We found evidence of postrandomisation differential recruitment: the number of children recruited to the intervention arm was higher (292 vs 209); over half were recruited by prescribing nurses compared with less than a third in the control arm; children in the intervention arm were younger (median age 2 vs 3 years controls, p=0.03) and appeared to be more unwell than those in the control arm with higher respiratory rates (p<0.0001), wheeze prevalence (p=0.007) and global illness severity scores assessed by carers (p=0.045) and clinicians (p=0.01). Interviews with clinicians confirmed preferential recruitment of less unwell children to the trial, more so in the control arm.

Conclusion

Differential recruitment may explain the paradoxical antibiotic prescribing rates. Future cluster level studies should consider designs which remove the need for individual consent postrandomisation and embed the intervention within electronic primary care records.

Trial registration number

ISRCTN 23547970 UKCRN STUDY ID: 16891.

SUBMITTER: Blair PS

PROVIDER: S-EPMC5623421 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Publications

Feasibility cluster randomised controlled trial of a within-consultation intervention to reduce antibiotic prescribing for children presenting to primary care with acute respiratory tract infection and cough.

Blair Peter S PS Turnbull Sophie S Ingram Jenny J Redmond Niamh N Lucas Patricia Jane PJ Cabral Christie C Hollinghurst Sandra S Dixon Padraig P Peters Tim T Horwood Jeremy J Little Paul P Francis Nick A NA Gilbertson Anna A Jameson Catherine C Hay Alastair D AD

BMJ open 20170509 5

<h4>Objective</h4>To investigate recruitment and retention, data collection methods and the acceptability of a 'within-consultation' complex intervention designed to reduce antibiotic prescribing.<h4>Design</h4>Primary care feasibility cluster randomised controlled trial.<h4>Setting</h4>32 general practices in South West England recruiting children from October 2014 to April 2015.<h4>Participants</h4>Children (aged 3 months to <12 years) with acute cough and respiratory tract infection (RTI).<h4 ...[more]

PMID: 28490554

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Project description:IntroductionRespiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development and proliferation of antimicrobial resistance. In 2016, the National Institute for Health Research (NIHR)-funded 'TARGET' programme developed a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics. The intervention includes: (1) explicit elicitation of parental concerns, (2) the results of the prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. The CHIldren's COugh feasibility study suggested differential recruitment of healthier patients in control practices. This phase III 'efficiently designed' trial uses routinely collected data at the practice level, thus avoiding individual patient consent. The aim is to assess whether embedding a multifaceted intervention into general practitioner (GP) practice Information Technology (IT) systems will result in reductions of antibiotic prescribing without impacting on hospital attendance for RTI.Methods and analysisThe coprimary outcomes are (1) practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs). Data will be collected for children aged 0-9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period. Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice. Secondary outcomes will explore intervention effect modifiers. Qualitative interviews will explore intervention usage. The economic evaluation will be limited to a between-arm comparison in a cost-consequence analysis.Ethics and disseminationResearch ethics approval was given by London-Camden and Kings Cross Research Ethics Committee (ref:18/LO/0345). This manuscript refers to protocol V.4.0. Results will be disseminated through peer-reviewed journals and international conferences.Trial registration numberISRCTN11405239.

Project description:IntroductionUp to 80% of patients with respiratory tract infections (RTI) attending healthcare facilities in rural areas of China are prescribed antibiotics, many of which are unnecessary. Since 2009, China has implemented several policies to try to reduce inappropriate antibiotic use; however, antibiotic prescribing remains high in rural health facilities.Methods and analysisA cluster randomised controlled trial will be carried out to estimate the effectiveness and cost effectiveness of a complex intervention in reducing antibiotic prescribing at township health centres in Anhui Province, China. 40 Township health centres will be randomised at a 1:1 ratio to the intervention or usual care arms. In the intervention group, practitioners will receive an intervention comprising: (1) training to support appropriate antibiotic prescribing for RTI, (2) a computer-based treatment decision support system, (3) virtual peer support, (4) a leaflet for patients and (5) a letter of commitment to optimise antibiotic use to display in their clinic. The primary outcome is the percentage of antibiotics (intravenous and oral) prescribed for RTI patients. Secondary outcomes include patient symptom severity and duration, recovery status, satisfaction, antibiotic consumption. A full economic evaluation will be conducted within the trial period. Costs and savings for both clinics and patients will be considered and quality of life will be measured by EuroQoL (EQ-5D-5L). A qualitative process evaluation will explore practitioner and patient views and experiences of trial processes, intervention fidelity and acceptability, and barriers and facilitators to implementation.Ethics and disseminationEthical approval was obtained from the Biomedical Research Ethics Committee of Anhui Medical University (Ref: 20180259); the study has undergone due diligence checks and is registered at the University of Bristol (Ref: 2020-3137). Research findings will be disseminated to stakeholders through conferences and peer-reviewed journals in China, the UK and internationally.Trial registration numberISRCTN30652037.

Project description:BACKGROUND:Inappropriate antibiotic prescribing causes widespread serious health problems. To reduce prescribing of antibiotics in Chinese primary care to children with upper respiratory tract infections (URTIs), we developed an intervention comprising clinical guidelines, monthly prescribing review meetings, doctor-patient communication skills training, and education materials for caregivers. We previously evaluated our intervention using an unblinded cluster-randomised controlled trial (cRCT) in 25 primary care facilities across two rural counties. When our trial ended at the 6-month follow-up period, we found that the intervention had reduced antibiotic prescribing for childhood URTIs by 29 percentage points (pp) (95% CI -42 to -16). METHODS AND FINDINGS:In this long-term follow-up study, we collected our trial outcomes from the one county (14 facilities and 1:1 cluster randomisation ratio) that had electronic records available 12 months after the trial ended, at the 18-month follow-up period. Our primary outcome was the antibiotic prescription rate (APR)-the percentage of outpatient prescriptions containing any antibiotic(s) for children aged 2 to 14 years who had a primary diagnosis of a URTI and had no other illness requiring antibiotics. We also conducted 15 in-depth interviews to understand how interventions were sustained. In intervention facilities, the APR was 84% (1,171 out of 1,400) at baseline, 37% (515 out of 1,380) at 6 months, and 54% (2,748 out of 5,084) at 18 months, and in control facilities, it was 76% (1,063 out of 1,400), 77% (1,084 out of 1,400), and 75% (2,772 out of 3,685), respectively. After adjusting for patient and prescribing doctor covariates, compared to the baseline intervention-control difference, the difference at 6 months represented a 6-month intervention-arm reduction in the APR of -49 pp (95% CI -63 to -35; P < 0.0001), and compared to the baseline difference, the difference at 18 months represented an 18-month intervention-arm reduction in the APR of -36 pp (95% CI -55 to -17; P < 0.0001). Compared to the 6-month intervention-control difference, the difference at 18 months represented no change in the APR: 13 pp (95% CI -7 to 33; P = 0.21). Factors reported to sustain reductions in antibiotic prescribing included doctors' improved knowledge and communication skills and focused prescription review meetings, whereas lack of supervision and monitoring may be associated with relapse. Key limitations were not including all clusters from the trial and not collecting returned visits or sepsis cases. CONCLUSIONS:Our intervention was associated with sustained and substantial reductions in antibiotic prescribing at the end of the intervention period and 12 months later. Our intervention may be adapted to similar resource-poor settings. TRIAL REGISTRATION:ISRCTN registry ISRCTN14340536.

Project description:OBJECTIVES:The validated 'STARWAVe' (Short illness duration, Temperature, Age, Recession, Wheeze, Asthma, Vomiting) clinical prediction rule (CPR) uses seven variables to guide risk assessment and antimicrobial stewardship in children presenting with cough. We aimed to compare general practitioners' (GPs) risk assessments and prescribing decisions to those of STARWAVe and assess the influence of the CPR's clinical variables. SETTING:Primary care. PARTICIPANTS:252 GPs, currently practising in the UK. DESIGN:GPs were randomly assigned to view four (of a possible eight) clinical vignettes online. Each vignette depicted a child presenting with cough, who was described in terms of the seven STARWAVe variables. Systematically, we manipulated patient age (20 months vs 5 years), illness duration (3 vs 6 days), vomiting (present vs absent) and wheeze (present vs absent), holding the remaining STARWAVe variables constant. OUTCOME MEASURES:Per vignette, GPs assessed risk of hospitalisation and indicated whether they would prescribe antibiotics or not. RESULTS:GPs overestimated risk of hospitalisation in 9% of vignette presentations (88/1008) and underestimated it in 46% (459/1008). Despite underestimating risk, they overprescribed: 78% of prescriptions were unnecessary relative to GPs' own risk assessments (121/156), while 83% were unnecessary relative to STARWAVe risk assessments (130/156). All four of the manipulated variables influenced risk assessments, but only three influenced prescribing decisions: a shorter illness duration reduced prescribing odds (OR 0.14, 95%?CI 0.08 to 0.27, p<0.001), while vomiting and wheeze increased them (ORvomit 2.17, 95%?CI 1.32 to 3.57, p=0.002; ORwheeze 8.98, 95%?CI 4.99 to 16.15, p<0.001). CONCLUSIONS:Relative to STARWAVe, GPs underestimated risk of hospitalisation, overprescribed and appeared to misinterpret illness duration (prescribing for longer rather than shorter illnesses). It is important to ascertain discrepancies between CPRs and current clinical practice. This has implications for the integration of CPRs into the electronic health record and the provision of intelligible explanations to decision-makers.

Project description:ObjectivesTo determine the feasibility of conducting a randomised trial of the effectiveness of cranberry extract in reducing antibiotic use by women with symptoms of acute, uncomplicated urinary tract infection (UTI).DesignOpen-label feasibility randomised parallel group trial.SettingFour general practices in Oxfordshire.ParticipantsWomen aged 18 years and above presenting to general practice with symptoms of acute, uncomplicated UTI.InterventionsWomen were randomly assigned using Research Electronic Data Capture in a 1:1:1 ratio to: (1) immediate antibiotics alone (n=15); (2) immediate antibiotics and immediate cranberry capsules for up to 7 days (n=15); or (3) immediate cranberry capsules and delayed antibiotics for self-initiation in case of non-improvement or worsening of symptoms (n=16).Primary and secondary outcome measuresThe primary outcome measures were: rate of recruitment of participants; numbers lost to follow-up; proportion of electronic diaries completed by participants; and acceptability of the intervention and study procedures to participants and recruiters. Secondary outcomes included an exploration of differences in symptom burden and antibiotic use between groups.ResultsFour general practitioner practices (100%) were opened and recruited participants between 1 July and 2 December 2019, with nine study participants recruited per month on average. 68.7% (46/67) of eligible participants were randomised (target 45) with a mean age of 48.4 years (SD 19.9, range 18-81). 89.1% (41/46) of diaries contained some participant entered data and 69.6% (32/46) were fully complete. Three participants (6.5%) were lost to follow-up and two (4.4%) withdrew. Of women randomly assigned to take antibiotics alone (controls), one-third of respondents reported consuming cranberry products (33.3%, 4/12). There were no serious adverse events.ConclusionsIt appears feasible to conduct a randomised trial of the use of cranberry extract in the treatment of acute, uncomplicated UTI in general practice.Trial registration numberISRCTN Registry (ID: 10399299).

Project description:To assess the effects of a multifaceted educational intervention in Norwegian general practice aiming to reduce antibiotic prescription rates for acute respiratory tract infections and to reduce the use of broad spectrum antibiotics.Cluster randomised controlled study.Existing continuing medical education groups were recruited and randomised to intervention or control.79 groups, comprising 382 general practitioners, completed the interventions and data extractions.The intervention groups had two visits by peer academic detailers, the first presenting the national clinical guidelines for antibiotic use and recent research evidence on acute respiratory tract infections, the second based on feedback reports on each general practitioner's antibiotic prescribing profile from the preceding year. Regional one day seminars were arranged as a supplement. The control arm received a different intervention targeting prescribing practice for older patients.Prescription rates and proportion of non-penicillin V antibiotics prescribed at the group level before and after the intervention, compared with corresponding data from the controls.In an adjusted, multilevel model, the effect of the intervention on the 39 intervention groups (183 general practitioners) was a reduction (odds ratio 0.72, 95% confidence interval 0.61 to 0.84) in prescribing of antibiotics for acute respiratory tract infections compared with the controls (40 continuing medical education groups with 199 general practitioners). A corresponding reduction was seen in the odds (0.64, 0.49 to 0.82) for prescribing a non-penicillin V antibiotic when an antibiotic was issued. Prescriptions per 1000 listed patients increased from 80.3 to 84.6 in the intervention arm and from 80.9 to 89.0 in the control arm, but this reflects a greater incidence of infections (particularly pneumonia) that needed treating in the intervention arm.The intervention led to improved antibiotic prescribing for respiratory tract infections in a representative sample of Norwegian general practitioners, and the courses were feasible to the general practitioners.Clinical trials NCT00272155.

Project description:ObjectivesTo 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.DesignOpen label, two arm, cluster randomised controlled trial.SettingUK 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.Participants79 general practices (582 675 patient years) randomised (1:1) to antimicrobial stewardship (AMS) intervention or usual care.InterventionsAMS 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 measuresPrimary 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.ResultsThe 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).ConclusionsElectronically 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 registrationISRCTN95232781.

Dataset Information

Feasibility cluster randomised controlled trial of a within-consultation intervention to reduce antibiotic prescribing for children presenting to primary care with acute respiratory tract infection and cough.

Objective

Design

Setting

Participants

Intervention

Controls

Results

Conclusion

Trial registration number

Publications

Feasibility cluster randomised controlled trial of a within-consultation intervention to reduce antibiotic prescribing for children presenting to primary care with acute respiratory tract infection and cough.

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