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Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data.

ABSTRACT: High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions to improve care are attractive because they are relatively cheap to widely implement. There is good evidence that feedback has small to moderate effects, but the most recent Cochrane review called for more high-quality, large trials that explicitly test different forms of feedback.The study is a three-arm cluster-randomised trial with general practices being randomised and outcomes measured at patient level. 262 practices in three Scottish Health Board areas have been randomised (94% of all possible practices). The two active arms receive different forms of prescribing safety data feedback, with rates of high-risk prescribing compared with a 'usual care' arm. Sample size estimation used baseline data from participating practices. With 85 practices randomised to each arm, then there is 93% power to detect a 25% difference in the percentage of high-risk prescribing (from 6.1% to 4.5%) between the usual care arm and each intervention arm. The primary outcome is a composite of six high-risk prescribing measures (antipsychotic prescribing to people aged ?75 years; non-steroidal anti-inflammatory drug (NSAID) prescribing to people aged ?75 without gastroprotection; NSAID prescribing to people prescribed aspirin/clopidogrel without gastroprotection; NSAID prescribing to people prescribed an ACE inhibitor/angiotensin receptor blocker and a diuretic; NSAID prescription to people prescribed an oral anticoagulant without gastroprotection; aspirin/clopidogrel prescription to people prescribed an oral anticoagulant without gastroprotection). The primary analysis will use multilevel modelling to account for repeated measurement of outcomes in patients clustered within practices.The study was reviewed and approved by the NHS Tayside Committee on Medical Research Ethics B (11/ES/0001). The study will be disseminated via a final report to the funder with a publicly available research summary, and peer reviewed publications.ClinicalTrials.gov, dossier number NCT01602705.

SUBMITTER: Guthrie B

PROVIDER: S-EPMC3533102 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data.

Guthrie Bruce B Treweek Shaun S Petrie Dennis D Barnett Karen K Ritchie Lewis D LD Robertson Chris C Bennie Marion M

BMJ open 20121213 6

<h4>Introduction</h4>High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions to improve care are attractive because they are relatively cheap to widely implement. There is good evidence that feedback has small to moderate effects, but the most recent Cochrane review called for more high-quality, large trials that explicitly test different forms of feedback.<h4>Methods and analysis</h4>The study is a three-arm cluster-randomised trial with general prac ...[more]

PMID: 23242239

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Project description:BackgroundHigh-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices.MethodsThe NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: (1) educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study.ResultsSix high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2×).ConclusionsThe paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings.Trial registrationClinicalTrials.gov: NCT01602705.

Project description:Objective To evaluate the effectiveness of feedback on safety of prescribing compared with moderately enhanced usual care.Design Three arm, highly pragmatic cluster randomised trial.Setting and participants 262/278 (94%) primary care practices in three Scottish health boards.Interventions Practices were randomised to: "usual care," consisting of emailed educational material with support for searching to identify patients (88 practices at baseline, 86 analysed); usual care plus feedback on practice's high risk prescribing sent quarterly on five occasions (87 practices, 86 analysed); or usual care plus the same feedback incorporating a behavioural change component (87 practices, 86 analysed).Main outcome measures The primary outcome was a patient level composite of six prescribing measures relating to high risk use of antipsychotics, non-steroidal anti-inflammatories, and antiplatelets. Secondary outcomes were the six individual measures. The primary analysis compared high risk prescribing in the two feedback arms against usual care at 15 months. Secondary analyses examined immediate change and change in trend of high risk prescribing associated with implementation of the intervention within each arm.Results In the primary analysis, high risk prescribing as measured by the primary outcome fell from 6.0% (3332/55 896) to 5.1% (2845/55 872) in the usual care arm, compared with 5.9% (3341/56 194) to 4.6% (2587/56 478) in the feedback only arm (odds ratio 0.88 (95% confidence interval 0.80 to 0.96) compared with usual care; P=0.007) and 6.2% (3634/58 569) to 4.6% (2686/58 582) in the feedback plus behavioural change component arm (0.86 (0.78 to 0.95); P=0.002). In the pre-specified secondary analysis of change in trend within each arm, the usual care educational intervention had no effect on the existing declining trend in high risk prescribing. Both types of feedback were associated with significantly more rapid decline in high risk prescribing after the intervention compared with before.Conclusions Feedback of prescribing safety data was effective at reducing high risk prescribing. The intervention would be feasible to implement at scale in contexts where electronic health records are in general use.Trial registration Clinical trials NCT01602705.

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.

Project description:BackgroundTo evaluate the effectiveness of a structured prescription review and prescriber feedback program in reducing prescribing errors in government primary care clinics within an administrative region in Malaysia.MethodsThis was a three group, pragmatic, cluster randomised trial. In phase 1, we randomised 51 clinics to a full intervention group (prescription review and league tables plus authorised feedback letter), a partial intervention group (prescription review and league tables), and a control group (prescription review only). Prescribers in these clinics were the target of our intervention. Prescription reviews were performed by pharmacists; 20 handwritten prescriptions per prescriber were consecutively screened on a random day each month, and errors identified were recorded in a standardised data collection form. Prescribing performance feedback was conducted at the completion of each prescription review cycle. League tables benchmark prescribing errors across clinics and individual prescribers, while the authorised feedback letter detailed prescribing performance based on a rating scale. In phase 2, all clinics received the full intervention. Pharmacists were trained on data collection, and all data were audited by researchers as an implementation fidelity strategy. The primary outcome, percentage of prescriptions with at least one error, was displayed in p-charts to enable group comparison.ResultsA total of 32,200 prescriptions were reviewed. In the full intervention group, error reduction occurred gradually and was sustained throughout the 8-month study period. The process mean error rate of 40.7% (95% CI 27.4, 29.5%) in phase 1 reduced to 28.4% (95% CI 27.4, 29.5%) in phase 2. In the partial intervention group, error reduction was not well sustained and showed a seasonal pattern with larger process variability. The phase 1 error rate averaging 57.9% (95% CI 56.5, 59.3%) reduced to 44.8% (95% CI 43.3, 46.4%) in phase 2. There was no evidence of improvement in the control group, with phase 1 and phase 2 error rates averaging 41.1% (95% CI 39.6, 42.6%) and 39.3% (95% CI 37.8, 40.9%) respectively.ConclusionsThe rate of prescribing errors in primary care settings is high, and routine prescriber feedback comprising league tables and a feedback letter can effectively reduce prescribing errors.Trial registrationNational Medical Research Register: NMRR-12-108-11,289 (5th March 2012).

Project description:IntroductionPatients are a valuable source of information about ways to prevent harm in healthcare, and can provide feedback about the factors that contribute to safety incidents. The Primary Care Patient Measure of Safety (PC PMOS) is a novel and validated tool that captures patient feedback on safety and can be used by primary care practice teams to identify and prevent safety incidents. The aim of this study is to assess the feasibility of PC PMOS as a tool for data-driven safety improvement and monitoring in Australian primary care.Methods and analysisFeasibility will be assessed using a mixed-methods approach to understand the enablers, barriers, acceptability, practicability, intervention fidelity and scalability of C PMOS as a tool for safety improvement across six primary care practices in the south-west region of Victoria. Patients over the age of 18 years attending their primary care practice will be invited to complete the PC PMOS when presenting for an appointment. Staff members at each practice will form a safety improvement team. Staff will then use the patient feedback to develop and implement specific safety interventions over a 6-month period. Data collection methods during the intervention period includes audio recordings of staff meetings, overt observations at training and education workshops, reflexive researcher insights, document collection and review. Data collection postintervention includes patient completion of the PC PMOS and semistructured interviews with staff. Triangulation and thematic analysis techniques will be employed to analyse the qualitative and content data. Analysis methods will use current evidence and models of healthcare culture, safety improvement and patient involvement in safety to inform the findings.Ethics and disseminationEthics approval was granted by Deakin University Human Ethics Advisory Group, Faculty of Health (HEAG-H 175_2017). Study results will be disseminated through local and international conferences and peer-reviewed publications.

Project description:BACKGROUND:Frailty in elderly patients is associated with an increased risk of poor health outcomes, including falls, delirium, malnutrition, hospitalisation, and mortality. Because polypharmacy is recognised as a possible major contributor to the pathogenesis of geriatric frailty, reducing inappropriate medication exposure is supposed to be a promising approach to improve health-related quality of life and prevent adverse outcomes. A major challenge for the process of deprescribing of inappropriate polypharmacy is to improve the communication between general practitioner (GPs), patient and family carer. This study investigates the effects of a complex intervention in frail elderly patients with polypharmacy living at home. METHODS:This is a cluster randomised controlled trial including 136 GPs and 676 patients. Patients with a positive clinical screening for frailty are eligible if they are aged 70?years or older, receiving family or professional nursing care at home, and taking in five or more drugs per day. Exclusion criteria are higher grade of dementia and life expectancy of 6 months or less. The GPs of the intervention group receive an educational training promoting a deprescribing guideline and providing information on how to conduct a family conference focussing on prioritisation of treatment goals concerning drug therapy. During the 1-year intervention, GPs are expected to perform a total of three family conferences, each including a structured medication review with patients and their family carers. GPs of the control group will receive no training and will deliver care as usual. Geriatric assessment of all patients will be performed by study nurses during home visits at baseline and after 6 and 12 months. The primary outcome is the hospitalisation rate during the observation period of 12?months. Secondary outcomes are number and appropriateness of medications, mobility, weakness, cognition, depressive disorder, health-related quality of life, activities of daily living, weight, and costs of health care use. DISCUSSION:This study will provide evidence for a pragmatic co-operative and patient-centred educational intervention using family conferences to improve patient safety in frail elderly patients with polypharmacy. TRIAL REGISTRATION:German Clinical Trials Register, DRKS00015055 (WHO International Clinical Trials Registry Platform [ICTRP]). Registered on 6 February 2019.

Project description:ObjectivesThis study sought to assess the effectiveness and return on investment (ROI) of a multifaceted intervention aimed at improving antibiotic prescribing for acute respiratory infections in primary care.DesignLarge-sized, two-arm, open-label, pragmatic, cluster-randomised controlled trial.SettingAll primary care physicians working for the Spanish National Health Service (NHS) in Galicia (region in north-west Spain).ParticipantsThe seven spatial clusters were distributed by unequal randomisation (3:4) of the intervention and control groups. A total of 1217 physicians (1.30 million patients) were recruited from intervention clusters and 1393 physicians (1.46 million patients) from control clusters.InterventionsOne-hour educational outreach visits tailored to training needs identified in a previous study; an online course integrated in practice accreditation; and a clinical decision support system.Main outcome measuresChanges in the ESAC (European Surveillance of Antimicrobial Consumption) quality indicators for outpatient antibiotic use. We used generalised linear mixed and conducted a ROI analysis to ascertain the overall cost savings.ResultsMedian follow-up was 19 months. The adjusted effect on overall antibiotic prescribing attributable to the intervention was - 4.2% (95% CI: - 5.3% to - 3.2%), with this being more pronounced for penicillins - 6.5 (95% CI: - 7.9% to - 5.2%) and for the ratio of consumption of broad- to narrow-spectrum penicillins, cephalosporins, and macrolides - 9.0% (95% CI: - 14.0 to - 4.1%). The cost of the intervention was €87 per physician. Direct savings per physician attributable to the reduction in antibiotic prescriptions was €311 for the NHS and €573 for patient contributions, with an ROI of €2.57 and €5.59 respectively.ConclusionsInterventions designed on the basis of gaps in physicians' knowledge of and attitudes to misprescription can improve antibiotic prescribing and yield important direct cost savings.Trial registrationCurrent Controlled Trials ISRCTN24158380 . Registered 5 February 2009.

Project description:BackgroundSmall trials with short term follow up suggest pharmacists' interventions targeted at healthcare professionals can improve prescribing. In comparison with clinical guidance, contemporary statin prescribing is sub-optimal and achievement of cholesterol targets falls short of accepted standards, for patients with atherosclerotic vascular disease who are at highest absolute risk and who stand to obtain greatest benefit. We hypothesised that a pharmacist-led complex intervention delivered to doctors and nurses in primary care, would improve statin prescribing and achievement of cholesterol targets for incident and prevalent patients with vascular disease, beyond one year.MethodsWe allocated general practices to a 12-month Statin Outreach Support (SOS) intervention or usual care. SOS was delivered by one of 11 pharmacists who had received additional training. SOS comprised academic detailing and practical support to identify patients with vascular disease who were not prescribed a statin at optimal dose or did not have cholesterol at target, followed by individualised recommendations for changes to management. The primary outcome was the proportion of patients achieving cholesterol targets. Secondary outcomes were: the proportion of patients prescribed simvastatin 40 mg with target cholesterol achieved; cholesterol levels; prescribing of simvastatin 40 mg; prescribing of any statin and the proportion of patients with cholesterol tested. Outcomes were assessed after an average of 1.7 years (range 1.4-2.2 years), and practice level simvastatin 40 mg prescribing was assessed after 10 years.FindingsWe randomised 31 practices (72 General Practitioners (GPs), 40 nurses). Prior to randomisation a subset of eligible patients were identified to characterise practices; 40% had cholesterol levels below the target threshold. Improvements in data collection procedures allowed identification of all eligible patients (n = 7586) at follow up. Patients in practices allocated to SOS were significantly more likely to have cholesterol at target (69.5% vs 63.5%; OR 1.11, CI 1.00-1.23; p = 0.043) as a result of improved simvastatin prescribing. Subgroup analysis showed the primary outcome was achieved by prevalent but not incident patients. Statistically significant improvements occurred in all secondary outcomes for prevalent patients and all but one secondary outcome (the proportion of patients with cholesterol tested) for incident patients. SOS practices prescribed more simvastatin 40 mg than usual care practices, up to 10 years later.InterpretationThrough a combination of educational and organisational support, a general practice based pharmacist led collaborative intervention can improve statin prescribing and achievement of cholesterol targets in a high-risk primary care based population.Trial registrationInternational Standard Randomised Controlled Trials Register ISRCTN61233866.

Project description:BACKGROUND:Antibiotic prescribing in dentistry accounts for 9% of total antibiotic prescriptions in Scottish primary care. The Scottish Dental Clinical Effectiveness Programme (SDCEP) published guidance in April 2008 (2nd edition, August 2011) for Drug Prescribing in Dentistry, which aims to assist dentists to make evidence-based antibiotic prescribing decisions. However, wide variation in prescribing persists and the overall use of antibiotics is increasing. METHODS:RAPiD is a 12-month partial factorial cluster randomised trial conducted in NHS General Dental Practices across Scotland. Its aim is to compare the effectiveness of individualised audit and feedback (A&F) strategies for the translation into practice of SDCEP recommendations on antibiotic prescribing. The trial uses routinely collected electronic healthcare data in five aspects of its design in order to: identify the study population; apply eligibility criteria; carry out stratified randomisation; generate the trial intervention; analyse trial outcomes. Eligibility was determined on contract status and a minimum level of recent NHS treatment provision. All eligible dental practices in Scotland were simultaneously randomised at baseline either to current audit practice or to an intervention group. Randomisation was stratified by single-handed/multi-handed practices. General dental practitioners (GDPs) working at intervention practices will receive individualised graphical representations of their antibiotic prescribing rate from the previous 14 months at baseline and an update at six months. GDPs could not be blinded to their practice allocation. Intervention practices were further randomised using a factorial design to receive feedback with or without: a health board comparator; a supplementary text-based intervention; additional feedback at nine months. The primary outcome is the total antibiotic prescribing rate per 100 courses of treatment over the year following delivery of the baseline intervention. A concurrent qualitative process evaluation will apply theory-based approaches using the Consolidated Framework for Implementation Research to explore the acceptability of the interventions and the Theoretical Domains Framework to identify barriers and enablers to evidence-based antibiotic prescribing behaviour by GDPs. DISCUSSION:RAPiD will provide a robust evaluation of A&F in dentistry in Scotland. It also demonstrates that linked administrative datasets have the potential to be used efficiently and effectively across all stages of an randomised controlled trial. TRIAL REGISTRATION:Current Controlled Trials ISRCTN49204710.

Dataset Information

Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data.

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Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data.

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