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Personalized prescription feedback to reduce antibiotic overuse in primary care: rationale and design of a nationwide pragmatic randomized trial.

ABSTRACT: BACKGROUND:Antimicrobial resistance has become a serious worldwide public health problem and is associated with antibiotic overuses. Whether personalized prescription feedback to high antibiotic prescribers using routinely collected data can lower antibiotic use in the long run is unknown. METHODS:We describe the design and rationale of a nationwide pragmatic randomized controlled trial enrolling 2900 primary care physicians in Switzerland with high antibiotic prescription rates based on national reimbursement claims data. About 1450 physicians receive quarterly postal and online antibiotic prescription feedback over 24 months allowing a comparison of the individual prescription rates with peers. Initially, they also receive evidence based treatment guidelines. The 1450 physicians in the control group receive no information. The primary outcome is the amount of antibiotics prescribed over a one year-period, measured as defined daily doses per 100 consultations. Other outcomes include the amount of antibiotics prescribed to specific age groups (<6, 6 to 18, 19 to 65, >65 years), to male and female patients, in addition to prescriptions of specific antibiotic groups. Further analyses address disease-specific quality indicators for outpatient antibiotic prescriptions, the acceptance of the intervention, and the impact on costs. DISCUSSION:This trial investigates whether continuous personalized prescription feedback on a health system level using routinely collected health data reduces antibiotic overuse. The feasibility and applicability of a web-based interface for communication with primary care physicians is further assessed. TRIAL REGISTRATION:ClinTrials.gov NCT01773824 (Date registered: August 24, 2012).

SUBMITTER: Hemkens LG

PROVIDER: S-EPMC4988000 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Personalized prescription feedback to reduce antibiotic overuse in primary care: rationale and design of a nationwide pragmatic randomized trial.

Hemkens Lars G LG Saccilotto Ramon R Reyes Selene L SL Glinz Dominik D Zumbrunn Thomas T Grolimund Oliver O Gloy Viktoria V Raatz Heike H Widmer Andreas A Zeller Andreas A Bucher Heiner C HC

BMC infectious diseases 20160817

<h4>Background</h4>Antimicrobial resistance has become a serious worldwide public health problem and is associated with antibiotic overuses. Whether personalized prescription feedback to high antibiotic prescribers using routinely collected data can lower antibiotic use in the long run is unknown.<h4>Methods</h4>We describe the design and rationale of a nationwide pragmatic randomized controlled trial enrolling 2900 primary care physicians in Switzerland with high antibiotic prescription rates b ...[more]

PMID: 27530528

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Project description:Background:Small randomized trials demonstrated that a lower compared with higher dialysate temperature reduced the average drop in intradialytic blood pressure. Some observational studies demonstrated that a lower compared with higher dialysate temperature was associated with a lower risk of all-cause mortality and cardiovascular mortality. There is now the need for a large randomized trial that compares the effect of a low vs high dialysate temperature on major cardiovascular outcomes. Objective:The purpose of this study is to test the effect of outpatient hemodialysis centers randomized to (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol for 4 years on cardiovascular-related death and hospitalizations. Design:The design of the study is a pragmatic, registry-based, open-label, cluster randomized controlled trial. Setting:Hemodialysis centers in Ontario, Canada, were randomized on February 1, 2017, for a trial start date of April 3, 2017, and end date of March 31, 2021. Participants:In total, 84 hemodialysis centers will care for approximately 15 500 patients and provide over 4 million dialysis sessions over a 4-year follow-up. Intervention:Hemodialysis centers were randomized (1:1) to provide (1) a personalized temperature-reduced dialysate protocol or (2) a standard-temperature dialysate protocol of 36.5°C. For the personalized protocol, nurses set the dialysate temperature between 0.5°C and 0.9°C below the patient's predialysis body temperature for each dialysis session, to a minimum dialysate temperature of 35.5°C. Primary outcome:A composite of cardiovascular-related death or major cardiovascular-related hospitalization (a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) captured in Ontario health care administrative databases. Planned primary analysis:The primary analysis will follow an intent-to-treat approach. The hazard ratio of time-to-first event will be estimated from a Cox model. Within-center correlation will be considered using a robust sandwich estimator. Observation time will be censored on the trial end date or when patients die from a noncardiovascular event. Trial Registration:www.clinicaltrials.gov; identifier: NCT02628366.

Project description:Introduction: Pharmacological intervention is an important component of patient care. However, drugs are often inappropriately used. It is necessary for countries to implement strategies to improve the rational use of drugs, including independent information for healthcare professionals and the public, which must be supported by well-trained staff. The primary objectives of the EDU.RE.DRUG (Effectiveness of informative and/or educational interventions aimed at improving the appropriate use of drugs designed for general practitioners and their patients) study are the retrospective evaluation of rates of appropriate prescribing indicators (APIs) and the assessment of the effectiveness of informative and/or educational interventions addressed to general practitioners (GPs) and their patients, aimed at improving prescribing quality and promoting proper drug use. Methods and analysis: This is a prospective, multicentre, open-label, parallel-arm, controlled, pragmatic trial directed to GPs and their patients in two Italian regions (Campania and Lombardy). The study data are retrieved from administrative databases (Demographic, Pharmacy-refill, and Hospitalization databases) containing healthcare information of all beneficiaries of the National Health Service in the Local Health Units (LHUs) involved. According to LHU, the GPs/patients will be assigned to one of the following four intervention arms: (1) intervention on GPs and patients; (2) intervention on GPs; (3) intervention on patients; and (4) no intervention (control). The intervention designed for GPs consists of reports regarding the status of their patients according to the APIs determined at baseline and in two on-line Continuous Medical Education (CME) courses. The intervention designed for patients consists in flyers and posters distributed in GPs ambulatories and community pharmacies, focusing on correct drug use. A set of indicators (such as potential drug–drug interactions, unnecessary duplicate prescriptions, and inappropriate prescriptions in the elderly), adapted to the Italian setting, has been defined to determine inappropriate prescription at baseline and after the intervention phase. The primary outcome was a composite API. Ethics and dissemination: The study was approved by the Ethics Committee of the University of Milan on 7th June 2017 (code 15/17). The investigators will communicate trial results to stakeholders, collaborators, and participants via appropriate presentations and publications. Registration details: NCT04030468. EudraCT number 2017-002622-21

Project description:Background and aims Given the widespread use of cannabis, and the concomitant risks associated with the drug, there is a need to increase the availability of interventions designed to reduce risky cannabis use. One promising intervention in the addictions employs personalized normative feedback to motivate change. Methods A two-arm randomized controlled trial (RCT) was conducted in which participants who used cannabis in a risky fashion were randomly assigned to one of two groups – those who received an online personalized feedback report in addition to educational materials about risky cannabis use and those who just received the online educational materials. Follow-up assessment occurred at three- and six-months post-randomization. Outcome variables included: number of days cannabis was used in the past 30, risky cannabis use (ASSIST score of four or more), and participant estimates of the proportion of cannabis users among those of the same age and gender. Results A total of 744 participants with risky cannabis use were recruited for the trial using online advertisements. There were no significant differences between intervention and educational materials only groups at three- and six-month follow-ups for the outcome variables, number of days used cannabis in the last 30 (p = 0.927) and proportion of participants engaging in risky cannabis use (p = 0.557). At three and six month follow-ups, participants who received the feedback intervention were more likely than those in the educational materials group to estimate that a larger proportion of people their age and gender did not use cannabis in the last year (p = 0.028). Discussion and conclusion While there was some evidence that the personalized feedback intervention modified normative perceptions about cannabis use, there did not appear to be support for the prediction that the intervention reduced cannabis consumption. Highlights • Personalized feedback intervention for risky cannabis use impacted normative misperceptions compared to educational control• Cannabis use did not appear to change as a result of providing individuals with a personalized feedback intervention

Project description:BackgroundInterventions to support decision-making can reduce inappropriate antibiotic use for acute respiratory infections (ARI), but they may not be sustainable. The objective of the study is to evaluate the long-term effectiveness of a clinical decision-support system (CDSS) interposed at the time of electronic (e-) prescriptions for selected antibiotics.MethodsThis is a retrospective, observational intervention study, conducted within a large, statewide Veterans Affairs health system. Participants are outpatients with an initial visit for ARI. A CDSS was deployed upon e-prescription of selected antibiotics during the study period. From 01/2004 to 05/2006 (pre-withdrawal period), the CDSS targeted azithromycin and the fluoroquinolone gatifloxacin. From 05/2006 to 12/2011 (post-withdrawal period), the CDSS was retained for azithromycin but withdrawn for the fluoroquinolone. A manual record review was conducted to determine concordance of antibiotic prescription with ARI treatment guidelines.ResultsOf 1131 included ARI visits, 380 (33.6%) were guideline-concordant. For azithromycin, concordance did not change between the pre- and post-withdrawal periods, and adjusted odds of concordance was 8.8 for the full study period, compared to unrestricted antibiotics. For fluoroquinolones, guideline concordance decreased from 88.6% (39 of 44 visits) to 51.3% (59 of 115 visits), pre- vs. post-withdrawal periods (p < 0.005). The adjusted odds of concordance compared to "All Other Antibiotics" visits decreased from 24.4 (95% CI 9.0-66.3) pre-withdrawal to 5.5 (95% CI 3.5-8.8) post-withdrawal (p = .008). Concordance did not change between those same time periods for antibiotics that were never subjected to the intervention ("All Other Antibiotics").ConclusionsA CDSS interposed at the time of e-prescription of selected antibiotics can shift their use toward ARI treatment guidelines, and this effect can be maintained over the long term as long as the CDSS remains in place. Removal of the CDSS after 3.5 years of implementation resulted in a rise in guideline-discordant antibiotic use.

Project description:Post-menopausal osteopenic women are at increased risk for skeletal fractures. Current osteopenia treatment guidelines include exercise, however, optimal exercise regimens for attenuating bone mineral density (BMD) loss, or for addressing other fracture-related risk factors (e.g. poor balance, decreased muscle strength) are not well-defined. Tai Chi is an increasingly popular weight bearing mind-body exercise that has been reported to positively impact BMD dynamics and improve postural control, however, current evidence is inconclusive. This study will determine the effectiveness of Tai Chi in reducing rates of bone turnover in post-menopausal osteopenic women, compared with standard care, and will preliminarily explore biomechanical processes that might inform how Tai Chi impacts BMD and associated fracture risks.A total of 86 post-menopausal women, aged 45-70y, T-score of the hip and/or spine -1.0 and -2.5, have been recruited from primary care clinics of a large healthcare system based in Boston. They have been randomized to a group-based 9-month Tai Chi program plus standard care or to standard care only. A unique aspect of this trial is its pragmatic design, which allows participants randomized to Tai Chi to choose from a pre-screened list of community-based Tai Chi programs. Interviewers masked to participants' treatment group assess outcomes at baseline and 3 and 9 months after randomization. Primary outcomes are serum markers of bone resorption (C-terminal cross linking telopeptide of type I collagen), bone formation (osteocalcin), and BMD of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry). Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n = 16) to explore the feasibility of modeling skeletal mechanical loads and postural control as mediators of fracture risk.Results of this study will provide preliminary evidence regarding the value of Tai Chi as an intervention for decreasing fracture risk in osteopenic women. They will also inform the feasibility, value and potential limitations related to the use of pragmatic designs for the study of Tai Chi and related mind-body exercise. If the results are positive, this will help focus future, more in-depth, research on the most promising potential mechanisms of action identified by this study.This trial is registered in ClinicalTrials.gov, with the ID number of NCT01039012.

Project description:BackgroundMajor depressive disorder (MDD) is a highly prevalent mental disorder with large disease burden, high levels of relapse or persistence, and overall suboptimal outcomes of protocolized pharmacological and psychotherapeutic treatments. There is an urgent need to improve treatment effectiveness, possibly through systematic treatment personalization. In psychotherapeutic treatments this can be achieved by case conceptualization. To support this process, we developed the Therap-i module, which consists of personalized Experienced Sampling Methodology (ESM) and feedback. The Therap-i module is integrated into outpatient psychotherapeutic treatment as usual (TAU) for depression. The study aim is to investigate the efficacy of the Therap-i module in decreasing symptomatology in unresponsive or relapsing patients diagnosed with MDD. We hypothesize that the Therap-i module will contribute to TAU by i) decreasing depressive symptoms, and ii) improving general functioning, therapeutic working alliance, and illness perception. This paper provides details of the study rationale, aims, procedures, and a discussion on potential pitfalls and promises of the module.MethodsPatients diagnosed with MDD (n = 100) will enrol in a pragmatic two-armed randomized controlled trial. Randomization is stratified according to the patient's treatment resistance level assessed with the Dutch Method for quantification of Treatment Resistance in Depression (DM-TRD). All fill-out the Inventory of Depressive Symptomatology Self Report (IDS-SR), Outcome Questionnaire (OQ-45), Illness Perception Questionnaire Mental Health (IPQ-MH), and Work Alliance Inventory Self Report (WAI-SR). In the intervention arm, through close collaboration between patient, clinician, and researcher, a personalized ESM diary is developed based on the patient's case conceptualization. During the ESM monitoring period (8 weeks, 5 assessments/day), patients receive feedback three times, which is discussed among the abovementioned three parties. Both patients and clinicians will evaluate the Therap-i module.ResultsData collection is ongoing.DiscussionThis is the first study in which personalized ESM and feedback is integrated in outpatient psychotherapeutic TAU for depression. The labour intensive procedure and methodological pitfalls are anticipated challenges and were taken into account when designing the study. When hypotheses are confirmed, the Therap-i module may advance treatment for depression by providing insights into personalized patterns driving or perpetuating depressive complaints.Trial registrationTrial NL7190 (NTR7381) , registered prospectively 03-08-2018.

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Personalized prescription feedback to reduce antibiotic overuse in primary care: rationale and design of a nationwide pragmatic randomized trial.

Publications

Personalized prescription feedback to reduce antibiotic overuse in primary care: rationale and design of a nationwide pragmatic randomized trial.

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