Bayesian cohort and cross-sectional analyses of the PINCER trial: a pharmacist-led intervention to reduce medication errors in primary care.
Ontology highlight
ABSTRACT: Background
Medication errors are an important source of potentially preventable morbidity and mortality. The PINCER study, a cluster randomised controlled trial, is one of the world's first experimental studies aiming to reduce the risk of such medication related potential for harm in general practice. Bayesian analyses can improve the clinical interpretability of trial findings.Methods
Experts were asked to complete a questionnaire to elicit opinions of the likely effectiveness of the intervention for the key outcomes of interest--three important primary care medication errors. These were averaged to generate collective prior distributions, which were then combined with trial data to generate bayesian posterior distributions. The trial data were analysed in two ways: firstly replicating the trial reported cohort analysis acknowledging pairing of observations, but excluding non-paired observations; and secondly as cross-sectional data, with no exclusions, but without acknowledgement of the pairing. Frequentist and bayesian analyses were compared.Findings
Bayesian evaluations suggest that the intervention is able to reduce the likelihood of one of the medication errors by about 50 (estimated to be between 20% and 70%). However, for the other two main outcomes considered, the evidence that the intervention is able to reduce the likelihood of prescription errors is less conclusive.Conclusions
Clinicians are interested in what trial results mean to them, as opposed to what trial results suggest for future experiments. This analysis suggests that the PINCER intervention is strongly effective in reducing the likelihood of one of the important errors; not necessarily effective in reducing the other errors. Depending on the clinical importance of the respective errors, careful consideration should be given before implementation, and refinement targeted at the other errors may be something to consider.
SUBMITTER: Hemming K
PROVIDER: S-EPMC3369915 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundMedication errors are common in primary care and are associated with considerable risk of patient harm. We tested whether a pharmacist-led, information technology-based intervention was more effective than simple feedback in reducing the number of patients at risk of measures related to hazardous prescribing and inadequate blood-test monitoring of medicines 6 months after the intervention.MethodsIn this pragmatic, cluster randomised trial general practices in the UK were stratified by research site and list size, and randomly assigned by a web-based randomisation service in block sizes of two or four to one of two groups. The practices were allocated to either computer-generated simple feedback for at-risk patients (control) or a pharmacist-led information technology intervention (PINCER), composed of feedback, educational outreach, and dedicated support. The allocation was masked to researchers and statisticians involved in processing and analysing the data. The allocation was not masked to general practices, pharmacists, patients, or researchers who visited practices to extract data. [corrected]. Primary outcomes were the proportions of patients at 6 months after the intervention who had had any of three clinically important errors: non-selective non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to those with a history of peptic ulcer without co-prescription of a proton-pump inhibitor; β blockers prescribed to those with a history of asthma; long-term prescription of angiotensin converting enzyme (ACE) inhibitor or loop diuretics to those 75 years or older without assessment of urea and electrolytes in the preceding 15 months. The cost per error avoided was estimated by incremental cost-effectiveness analysis. This study is registered with Controlled-Trials.com, number ISRCTN21785299.Findings72 general practices with a combined list size of 480,942 patients were randomised. At 6 months' follow-up, patients in the PINCER group were significantly less likely to have been prescribed a non-selective NSAID if they had a history of peptic ulcer without gastroprotection (OR 0·58, 95% CI 0·38-0·89); a β blocker if they had asthma (0·73, 0·58-0·91); or an ACE inhibitor or loop diuretic without appropriate monitoring (0·51, 0·34-0·78). PINCER has a 95% probability of being cost effective if the decision-maker's ceiling willingness to pay reaches £75 per error avoided at 6 months.InterpretationThe PINCER intervention is an effective method for reducing a range of medication errors in general practices with computerised clinical records.FundingPatient Safety Research Portfolio, Department of Health, England.
| S-EPMC3328846 | biostudies-literature
Project description:IntroductionMedication errors are avoidable events that can occur at any stage of the medication use process. They are widespread in healthcare systems and are linked to an increased risk of morbidity and mortality. Several strategies have been studied to reduce their occurrence including different types of pharmacy-based interventions. One of the main pharmacist-led interventions is educational programs, which seem to have promising benefits.ObjectiveTo describe and compare various pharmacist-led educational interventions delivered to healthcare providers and to evaluate their impact qualitatively and quantitatively on medication error rates.MethodsA systematic review and meta-analysis was conducted through searching Cochrane Library, EBSCO, EMBASE, Medline and Google Scholar from inception to June 2020. Only interventional studies that reported medication error rate change after the intervention were included. Two independent authors worked through the data extraction and quality assessment using Crowe Critical Appraisal Tool (CCAT). Summary odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using a random-effects model for rates of medication errors. Research protocol is available in The International Prospective Register of Systematic Reviews (PROSPERO) under the registration number CRD42019116465.ResultsTwelve studies involving 115058 participants were included. The two main recipients of the educational interventions were nurses and resident physicians. Educational programs involved lectures, posters, practical teaching sessions, audit and feedback method and flash cards of high-risk abbreviations. All studies included educational sessions as part of their program, either alone or in combination with other approaches, and most studies used errors encountered before implementing the intervention to inform the content of these sessions. Educational programs led by a pharmacist were associated with significant reductions in the overall rate of medication errors occurrence (OR, 0.38; 95% CI, 0.22 to 0.65).ConclusionPharmacist-led educational interventions directed to healthcare providers are effective at reducing medication error rates. This review supports the implementation of pharmacist-led educational intervention aimed at reducing medication errors.
| S-EPMC8221459 | biostudies-literature
Project description:BackgroundWe previously reported on a randomised trial demonstrating the effectiveness and cost-effectiveness of a pharmacist-led information technology intervention (PINCER). We sought to investigate whether PINCER was effective in reducing hazardous prescribing when rolled out at scale in UK general practices.Methods and findingsWe used a multiple interrupted time series design whereby successive groups of general practices received the PINCER intervention between September 2015 and April 2017. We used 11 prescribing safety indicators to identify potentially hazardous prescribing and collected data over a maximum of 16 quarterly time periods. The primary outcome was a composite of all the indicators; a composite for indicators associated with gastrointestinal (GI) bleeding was also reported, along with 11 individual indicators of hazardous prescribing. Data were analysed using logistic mixed models for the quarterly event numbers with the appropriate denominator, and calendar time included as a covariate. PINCER was implemented in 370 (94.1%) of 393 general practices covering a population of almost 3 million patients in the East Midlands region of England; data were successfully extracted from 343 (92.7%) of these practices. For the primary composite outcome, the PINCER intervention was associated with a decrease in the rate of hazardous prescribing of 16.7% (adjusted odds ratio (aOR) 0.83, 95% confidence interval (CI) 0.80 to 0.86) at 6 months and 15.3% (aOR 0.85, 95% CI 0.80 to 0.90) at 12 months postintervention. The unadjusted rate of hazardous prescribing reduced from 26.4% (22,503 patients in the numerator/853,631 patients in the denominator) to 20.1% (11,901 patients in the numerator/591,364 patients in the denominator) at 6 months and 19.1% (3,868 patients in the numerator/201,992 patients in the denominator). The greatest reduction in hazardous prescribing associated with the intervention was observed for the indicators associated with GI bleeding; for the GI composite indicator, there was a decrease of 23.9% at both 6 months (aOR 0.76, 95% CI 0.73 to 0.80) and 12 months (aOR 0.76, 95% CI 0.70 to 0.82) postintervention. The unadjusted rate of hazardous prescribing reduced from 31.4 (16,185 patients in the numerator/515,879 patients in the denominator) to 21.2% (7,607 patients in the numerator/358,349 patients in the denominator) at 6 months and 19.5% (2,369 patients in the numerator/121,534 patients in the denominator). We adjusted for calendar time and practice, but since this was an observational study, the findings may have been influenced by unknown confounding factors or behavioural changes unrelated to the PINCER intervention. Data were also not collected for all practices at 6 months and 12 months postintervention.ConclusionsThe PINCER intervention, when rolled out at scale in routine clinical practice, was associated with a reduction in hazardous prescribing by 17% and 15% at 6 and 12 months postintervention. The greatest reductions in hazardous prescribing were for indicators associated with risk of GI bleeding. These findings support the wider national rollout of PINCER in England.
| S-EPMC9718399 | biostudies-literature
Project description:Background and objectivesMedication safety events are predominant contributors to suboptimal graft outcomes in kidney transplant recipients. The goal of this study was to examine the efficacy of improving medication safety through a pharmacist-led, mobile health-based intervention.Design, setting, participants, & measurementsThis was a 12-month, single-center, prospective, parallel, two-arm, single-blind, randomized controlled trial. Adult kidney recipients 6-36 months post-transplant were eligible. Participants randomized to intervention received supplemental clinical pharmacist-led medication therapy monitoring and management via a mobile health-based application, integrated with risk-guided televisits and home-based BP and glucose monitoring. The application provided an accurate medication regimen, timely reminders, and side effect surveys. Both the control and intervention arms received usual care, including serial laboratory monitoring and regular clinic visits. The coprimary outcomes were to assess the incidence and severity of medication errors and adverse events.ResultsIn total, 136 kidney transplant recipients were included, 68 in each arm. The mean age was 51 years, 57% were male, and 64% were Black individuals. Participants receiving the intervention experienced a significant reduction in medication errors (61% reduction in the risk rate; incident risk ratio, 0.39; 95% confidence interval, 0.28 to 0.55; P<0.001) and a significantly lower incidence risk of Grade 3 or higher adverse events (incident risk ratio, 0.55, 95% confidence interval, 0.30 to 0.99; P=0.05). For the secondary outcome of hospitalizations, the intervention arm demonstrated significantly lower rates of hospitalizations (incident risk ratio, 0.46; 95% confidence interval, 0.27 to 0.77; P=0.005).ConclusionsWe demonstrated a significant reduction in medication errors, adverse events, and hospitalizations using a pharmacist-led, mobile health-based intervention.
| S-EPMC8259471 | biostudies-literature
Project description:AimsTo develop and evaluate a feasible, authentic pharmacist-led prescribing feedback intervention for doctors-in-training, to reduce prescribing errors.MethodsThis was a mixed methods study. Sixteen postgraduate doctors-in training, rotating though the surgical assessment unit of 1 UK hospital, were filmed taking a medication history with a patient and prescribing medications. Each doctor reviewed their video footage and made plans to improve their prescribing, supported by feedback from a pharmacist. Quantitative data in the form of prescribing error prevalence data were collected on 1 day per week before, during and after the intervention period (between November 2015 and March 2017). Qualitative data in the form of individual semi-structured interviews were collected with a subset of participants, to evaluate their experience. Quantitative data were analysed using a statistical process chart and qualitative data were transcribed and analysed thematically.ResultsDuring the data collection period, 923 patient drug charts were reviewed by pharmacists who identified 1219 prescribing errors overall. Implementation of this feedback approach was associated with a statistically significant reduction in the mean number of prescribing errors, from 19.0/d to 11.7/d (estimated to equate to 38% reduction; P < .0001). Pharmacist-led video-stimulated prescribing feedback was feasible and positively received by participants, who appreciated the reinforcement of good practice as well as the opportunity to reflect on and improve practice.ConclusionsFeedback to doctors-in-training tends to be infrequent and often negative, but this feasible feedback strategy significantly reduced prescribing errors and was well received by the target audience as a supportive developmental approach.
| S-EPMC6783579 | biostudies-literature
Project description:AimsThe aim of this meta-analysis is to examine the impact of in-hospital pharmacist-led medication reviews in paediatric and adult patients.MethodsRelevant studies were identified from the Medline and Cochrane Library databases. Studies were included if they met the following criteria (without any language or date restrictions): design: randomized controlled trial; intervention: in-hospital pharmacist-led medication review (experimental group) vs. usual care (control group); participants: paediatric or adult population. The primary outcome was all-cause readmissions and/or emergency department (ED) visits at different time points. The secondary outcomes were all-cause readmissions, all-cause ED visits, drug-related readmissions, mortality, length of hospital stay, adherence and quality of life. We calculated the relative risk (RR) or mean differences (MD) with 95% confidence intervals (CIs) for each study. We used fixed and/or random effects models. Heterogeneity was assessed using the I2 statistic.ResultsWe systematically reviewed 19 randomized controlled trials (4805 participants). The readmission rates did not differ between the experimental group and the control group (RR = 0.97, 95% CI 0.89; 1.05, p = 0.470). The secondary outcomes did not differ between the two groups, except for in drug-related readmissions, which were lower in the experimental group (RR = 0.25, 95% CI 0.14; 0.45, p < 0.001), and all-cause ED visits (RR = 0.70, 95% CI 0.59; 0.85 p = 0.001).ConclusionThe low-quality evidence in this analysis suggests an impact of pharmacist-led medication reviews on drug-related readmissions and all-cause ED visits. Few studies reported on adherence and quality of life. More high-quality randomized clinical trials are needed to assess the impact of pharmacist-led medication reviews on patient-relevant outcomes, including adherence and quality of life.
| S-EPMC5099542 | biostudies-literature
Project description:Clinically important medication errors are common after hospital discharge. They include preventable or ameliorable adverse drug events (ADEs), as well as medication discrepancies or nonadherence with high potential for future harm (potential ADEs).To determine the effect of a tailored intervention on the occurrence of clinically important medication errors after hospital discharge.Randomized, controlled trial with concealed allocation and blinded outcome assessors. (ClinicalTrials.gov registration number: NCT00632021)Two tertiary care academic hospitals.Adults hospitalized with acute coronary syndromes or acute decompensated heart failure.Pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge.The primary outcome was the number of clinically important medication errors per patient during the first 30 days after hospital discharge. Secondary outcomes included preventable or ameliorable ADEs, as well as potential ADEs.Among 851 participants, 432 (50.8%) had 1 or more clinically important medication errors; 22.9% of such errors were judged to be serious and 1.8% life-threatening. Adverse drug events occurred in 258 patients (30.3%) and potential ADEs in 253 patients (29.7%). The intervention did not significantly alter the per-patient number of clinically important medication errors (unadjusted incidence rate ratio, 0.92 [95% CI, 0.77 to 1.10]) or ADEs (unadjusted incidence rate ratio, 1.09 [CI, 0.86 to 1.39]). Patients in the intervention group tended to have fewer potential ADEs (unadjusted incidence rate ratio, 0.80 [CI, 0.61 to 1.04]).The characteristics of the study hospitals and participants may limit generalizability.Clinically important medication errors were present among one half of patients after hospital discharge and were not significantly reduced by a health-literacy-sensitive, pharmacist-delivered intervention.National Heart, Lung, and Blood Institute.
| S-EPMC3575734 | biostudies-literature
Project description:Transitions of care often lead to medication errors and unnecessary healthcare utilization. Medication reconciliation has been repeatedly shown to reduce this risk. However, the great majority of evidence is limited to the provision of medication reconciliation within clinical trials and countries with well-established clinical pharmacy. Thus, this pragmatic, prospective, controlled trial evaluated the effectiveness of routine pharmacist-led medication reconciliation compared to standard care on medication errors and unplanned healthcare utilization in adult general medical patients hospitalized in a teaching hospital in Slovenia. All patients hospitalized in a ward where medication reconciliation was integrated into routine clinical practice were included in the intervention group and received admission and discharge medication reconciliation, coupled with patient counselling. The control group consisted of randomly selected patients from the remaining medical wards. The primary study outcome was unplanned healthcare utilization within 30 days of discharge, and the secondary outcomes were clinically important medication errors at hospital discharge and serious unplanned healthcare utilization within 30 days of discharge. Overall, 414 patients (53.4% male, median 71 years) were included-225 in the intervention group and 189 in the control group. In the intervention group, the number of patients with clinically important medication errors at discharge was significantly lower (intervention vs control group: 9.3% vs 61.9%). Multiple logistic regression revealed that medication reconciliation reduced the likelihood of a clinically important medication error by 20-fold, while a higher number of medications on admission was associated with an increased likelihood. However, no significant differences were noted in any and serious unplanned healthcare utilization (intervention vs control group: 33.9% vs 27.8% and 20.3% vs 14.6%, respectively). The likelihood of serious healthcare utilization increased with the age of the patient, the number of medications on admission and being hospitalized for an acute medical condition. Our pragmatic trial confirmed that medication reconciliation, even when performed as part of routine clinical practice, led to a substantial reduction in the risk of clinically important medication errors at hospital discharge but not to a reduction in healthcare utilization. Medication reconciliation is a fundamental, albeit not sufficient, element to ensure patient safety after hospital discharge. Clinical Trial Registration: https://clinicaltrials.gov/search?id=NCT06207500, identifier NCT06207500.
| S-EPMC11007427 | biostudies-literature
Project description:Introduction: Non-adherence to medication is a complex health care problem. In spite of substantial efforts, up till now little progress has been made to effectively tackle the problem with adherence-enhancing interventions. The aim of this study was to investigate the effectiveness of a patient-tailored, pharmacist-led and theory-driven intervention program aimed to enhance self-reported adherence to antihypertensive medication. Materials and Methods: A parallel-group randomized controlled trial in 20 community pharmacies with nine months follow-up was conducted. Patients (45-75 years) using antihypertensive medication and considered non-adherent based on both pharmacy dispensing data and a self-report questionnaire were eligible to participate. The intervention program consisted of two consultations with the pharmacist to identify participants' barriers to adhere to medication and to counsel participants in overcoming these barriers. The primary outcome was self-reported medication adherence. Secondary outcomes were beliefs about medicines, illness perceptions, quality of life and blood pressure. Mixed-model and generalized estimating equation (GEE) analyses were used to assess overall effects of the intervention program and effects per time point. Results: 170 patients were included. No significant differences between intervention and control groups were found in self-reported adherence, quality of life, illness perceptions, beliefs about medicines (concern scale), and blood pressure. After nine months, intervention participants had significantly stronger beliefs about the necessity of using their medicines as compared to control participants (mean difference 1.25 [95% CI: 0.27 to 2.24], p = 0.012). Discussion: We do not recommend to implement the intervention program in the current form for this study population. Future studies should focus on how to select eligible patient groups with appropriate measures in order to effectively target adherence-enhancing interventions. Trial Register: NTR5017 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5017.
| S-EPMC6169131 | biostudies-literature
Project description:Medication safety for older persons represents an ongoing challenge. Inappropriate prescriptions--those with a high risk of evidence-based harm--persist in up to 25% of seniors, and account for a significant proportion of avoidable emergency department visits. This project is the sequel to the EMPOWER study, in which a novel consumer-targeted written knowledge transfer tool aimed at empowering older adults to act as drivers of benzodiazepine de-prescription resulted in a 27% reduction of inappropriate benzodiazepine use at 6-month follow-up (number needed to treat (NNT)?= 4). Failure to discontinue in the EMPOWER study was attributable to re-emerging symptoms among participants, prescribing inertia, and lack of knowledge and skills for substituting alternate therapy among physicians and pharmacists. To maximize de-prescription of inappropriate therapy, educational medication-risk reduction initiatives should be tested that simultaneously include patients, physicians and pharmacists. The objective of this trial is to: 1) test the beneficial effect of a new de-prescribing paradigm enlisting pharmacists to transfer knowledge to both patients and prescribers in a 2-pronged approach to reduce inappropriate prescriptions, compared to usual care and 2) evaluate the transferability of the EMPOWER study concept to other classes of inappropriate prescriptions.We intend to conduct a 3-year pragmatic cluster randomized parallel-group controlled trial to test the effect of the new de-prescribing intervention compared to usual care for reducing 4 classes of inappropriate prescriptions from the 2012 Beers criteria among 450 community-dwelling older adults with polypharmacy. Inappropriate prescriptions will include benzodiazepines, sulfonylurea hypoglycemic agents, first generation antihistamines and non-steroidal anti-inflammatory drugs. The study population is community-dwelling older adults recruited from community pharmacies in Quebec, Canada. The intervention was developed based on a systematic review of the evidence for each medication. Participants in the experimental group will receive the written educational program following randomization and have their pharmacist send their physicians an evidence-based pharmaceutical opinion to recommend de-prescription and be followed for a year. The control group will be wait-listed for 6 months.System change to effectively reduce medication risk among community-dwelling seniors requires a coordinated approach targeting physicians, pharmacists and patients. This trial will test the feasibility and effectiveness of a tripartite approach to de-prescribing.Registered via ClinicalTrials.gov on 31 January 2014, identifier: NCT02053194.
| S-EPMC4512085 | biostudies-literature