Medication Education for Dosing Safety: A Randomized Controlled Trial.
Ontology highlight
ABSTRACT: Study objective
This study sought to determine whether a brief intervention at the time of emergency department (ED) discharge can improve safe dosing of liquid acetaminophen and ibuprofen by parents or guardians.Methods
We performed a randomized controlled trial in the ED of parents and guardians of children 90 days to 11.9 years of age who were discharged with acetaminophen or ibuprofen, or both. Families were randomized to standard care or a teaching intervention combining lay language, simplified handouts, provision of an unmarked dosing syringe, and teach-back to confirm correct dosing. Participants were called 48 to 72 hours and 5 to 7 days after ED discharge to assess understanding of correct dosing. The primary outcome was defined as parent or guardian report of safe dosing at the time of first follow-up call. Our primary hypothesis was that the intervention would decrease the rate of error from 30% to 10% at 48- to 72-hour follow-up.Results
We enrolled 149 of 259 (58%) eligible subjects; 97 of 149 (65%) were reached at first follow-up call, of whom 35 of 97 (36%) received the intervention. Among those participants receiving the intervention, 25 of 35 (71%) were able to identify a safe dose for their child at the time of the first call compared with 28 of 62 (45%) of those in the control arm. The difference in proportions was 26% (95% confidence interval [CI] 7% to 46%). There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).Conclusions
A multifaceted intervention at the time of ED discharge-consisting of a simplified dosing handout, a teaching session, teach-back, and provision of a standardized dosing device-can improve parents' knowledge of safe dosing of liquid medications at 48 to 72 hours.
SUBMITTER: Naureckas Li C
PROVIDER: S-EPMC7857015 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Poorly designed labels and packaging are key contributors to medication errors. To identify attributes of labels and dosing tools that could be improved, we examined the extent to which dosing error rates are affected by tool characteristics (ie, type, marking complexity) and discordance between units of measurement on labels and dosing tools; along with differences by health literacy and language.Randomized controlled experiment in 3 urban pediatric clinics. English- or Spanish-speaking parents (n = 2110) of children ?8 years old were randomly assigned to 1 of 5 study arms and given labels and dosing tools that varied in unit pairings. Each parent measured 9 doses of medication (3 amounts [2.5, 5, and 7.5 mL] and 3 tools [1 cup, 2 syringes (0.2- and 0.5-mL increments)]), in random order. Outcome assessed was dosing error (>20% deviation; large error defined as > 2 times the dose).A total of 84.4% of parents made ?1 dosing error (21.0% ?1 large error). More errors were seen with cups than syringes (adjusted odds ratio = 4.6; 95% confidence interval, 4.2-5.1) across health literacy and language groups (P < .001 for interactions), especially for smaller doses. No differences in error rates were seen between the 2 syringe types. Use of a teaspoon-only label (with a milliliter and teaspoon tool) was associated with more errors than when milliliter-only labels and tools were used (adjusted odds ratio = 1.2; 95% confidence interval, 1.01-1.4).Recommending oral syringes over cups, particularly for smaller doses, should be part of a comprehensive pediatric labeling and dosing strategy to reduce medication errors.
| S-EPMC5051204 | 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:BACKGROUND: Several studies have documented that physical examination knowledge and skills are limited among medical trainees. OBJECTIVES: The objective of the study is to investigate the efficacy and acceptability of a novel online educational methodology termed 'interactive spaced-education' (ISE) as a method to teach the physical examination. DESIGN: The design of the study is randomized controlled trial. PARTICIPANTS: All 170 second-year students in the physical examination course at Harvard Medical School were eligible to enroll. MEASUREMENTS: Spaced-education items (questions and explanations) were developed on core physical examination topics and were content-validated by two experts. Based on pilot-test data, 36 items were selected for inclusion. Students were randomized to start the 18-week program in November 2006 or 12 weeks later. Students were sent 6 spaced-education e-mails each week for 6 weeks (cycle 1) which were then repeated in two subsequent 6-week cycles (cycles 2 and 3). Students submitted answers to the questions online and received immediate feedback. An online end-of-program survey was administered. RESULTS: One-hundred twenty students enrolled in the trial. Cycles 1, 2, and 3 were completed by 88%, 76%, and 71% of students, respectively. Under an intent-to-treat analysis, cycle 3 scores for cohort A students [mean 74.0 (SD 13.5)] were significantly higher than cycle 1 scores for cohort B students [controls; mean 59.0 (SD 10.5); P < .001], corresponding to a Cohen's effect size of 1.43. Eighty-five percent of participants (102 of 120) recommended the ISE program for students the following year. CONCLUSIONS: ISE can generate significant improvements in knowledge of the physical examination and is very well-accepted by students.
| S-EPMC2517927 | biostudies-other
Project description:Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity.This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18-45 y, with a body mass index (BMI) of >18.5 kg/m(2). Eighty-seven women were randomized to a weight gain prevention intervention delivered by a registered dietitian (RDG) or counselor (CSG), or to a control (CON) group. Eighty-one women (mean ± SD, age: 31.4 ± 8.1 y; BW: 76.1 ± 19.0 kg; BMI: 27.9 ± 6.8 kg/m(2)) completed baseline testing and were included in intention-to-treat analyses; anthropometric, blood pressure, dietary intake and physical activity measurements and biochemical markers of health were measured every three months. Data were analyzed using repeated measures ANCOVA, with significance at P < 0.01.Sixty-two percent of women met the weight gain prevention criteria (BW change within ±3 %) after one year; this did not differ by group assignment. Body fat % was lower in the RDG versus CSG and CON groups at all intervals (P < 0.001). Systolic blood pressure increased from month 6 to 9 and decreased from month 6 to 12 in the CON group (P < 0.001), with a significant group x time interaction (P < 0.01). Estimated carbohydrate intake (%) was higher in the RDG vs. CON group at month 9 (P < 0.01); fat intake (%) was lower in the RDG vs. CON group and CSG vs. CON group at months 3 and 9, respectively (P < 0.01). Estimated fruit intake (svgs/d) was higher in the RDG vs. CON group at months 3, 6, 9 and 12 (P < 0.01), and non-meat protein sources (svgs/d) was higher in the RDG vs. CSG and CON groups at month 3 (P < 0.001). Estimated energy, macronutrient and food group intakes did not change over time.A majority of all participants maintained BW over one year and were able to do so regardless of whether they received nutrition education. Additional studies that include a variety of clinical outcomes are needed to evaluate further aspects of nutrition education on weight gain prevention and health status over the long term.
| S-EPMC4815216 | biostudies-other
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:Three decades of research findings have documented the health effects of handling hazardous drugs. Oncology nurses are vulnerable due to frequent administration of antineoplastics, low adherence to equipment use, reported barriers to use, and perceived low risk of health effects. No interventions have been tested in a controlled, multi-site trial to increase nurses' use of protective equipment when handling hazardous drugs. The Drug Exposure Feedback and Education for Nurses' Safety (DEFENS) study will compare the efficacy of education (control) versus an audit and feedback intervention (treatment) on nurses' self-reported use of personal protective equipment when handling hazardous drugs. The treatment intervention will include tailored messages based on nurses' reported barriers to protective equipment use.The DEFENS Study is a cluster randomized controlled trial. We are enrolling cancer centers and will recruit nurse participants in April 2015. Eligible cancer centers employ at least 20 eligible registered nurses in the chemotherapy infusion setting and have on-site phlebotomy resources. Eligible participants are nurses who work at least 0.40 full-time equivalent hours in the chemotherapy infusion setting and have not received an antineoplastic drug for a health problem in the past year. An encrypted, user-authenticated website will administer surveys and deliver control and treatment interventions. The primary endpoint is the change in score on nurses' reports of the Revised Hazardous Drug Handling Questionnaire between baseline and approximately 18 months later. A baseline survey is completed after informed consent and is repeated 18 months later. Nurses in all sites who experience a drug spill will also report incidents as they occur; these reports inform the treatment intervention. Plasma will be obtained at baseline, approximately 18 months later (the primary endpoint), and with drug spill occurrences to measure hazardous drugs levels and to inform the treatment intervention. Potential mediators include knowledge of hazardous drug handling and perceived risk of drug exposure. We will examine whether personal factors and organizational factors moderate the intervention effects.Clinicaltrials.gov NCT02283164 , registered 31 October 2014.
| S-EPMC4411718 | biostudies-literature
Project description:BACKGROUND: Patient education materials can assist patient decision making on prostate cancer screening. OBJECTIVE: To explore the effectiveness of presenting health information on prostate cancer screening using video, internet, and written interventions on patient decision making, attitudes, knowledge, and screening interest. DESIGN: Randomized controlled trial. PARTICIPANTS: A total of 161 men aged over 45, who had never been screened for prostate cancer, were randomized to receive information on prostate cancer screening. MEASUREMENTS: Participants were assessed at baseline and 1-week postintervention for decisional conflict, screening interest, knowledge, anxiety, and decision-making preference. RESULTS: A total of 156 men were followed-up at 1-week postintervention. There was no statistical, or clinical, difference in mean change in decisional conflict scores between the 3 intervention groups (video vs internet -0.06 [95% CI -0.24 to 0.12]; video vs pamphlet 0.04 [95%CI -0.15 to 0.22]; internet vs pamphlet 0.10 [95%CI -0.09 to 0.28]). There was also no statistically significant difference in mean knowledge, anxiety, decision-making preference, and screening interest between the 3 intervention groups. CONCLUSION: Results from this study indicate that there are no clinically significant differences in decisional conflict when men are presented health information on prostate cancer screening via video, written materials, or the internet. Given the equivalence of the 3 methods, other factors need to be considered in deciding which method to use. Health professionals should provide patient health education materials via a method that is most convenient to the patient and their preferred learning style.
| S-EPMC2359522 | biostudies-other
Project description:BACKGROUND:Medication errors, adverse drug events, and nonadherence lead to increased health care utilization and increased risk of adverse clinical outcomes, including graft loss, in solid organ transplant recipients. Veterans living with organ transplants represent a population that is at substantial risk for medication safety events and fragmented care coordination issues. To improve medication safety and long-term clinical outcomes in veteran transplant patients, interventions should address interorganizational system failures and provider-level and patient-level factors. OBJECTIVE:This study aims to measure the clinical and economic effectiveness of a pharmacist-led, technology-enabled intervention, compared with usual care, in veteran organ transplant recipients. METHODS:This is a 24-month prospective, parallel-arm, cluster-randomized, controlled multicenter study. The pharmacist-led intervention uses an innovative dashboard system to improve medication safety and health outcomes, compared with usual posttransplant care. Pharmacists at 10 study sites will be consented into this study before undergoing randomization, and 5 sites will then be randomized to each study arm. Approximately, 1600 veteran transplant patients will be included in the assessment of the primary outcome across the 10 sites. RESULTS:This study is ongoing. Institutional review board approval was received in October 2018 and the study opened in March 2019. To date there are no findings from this study, as the delivery of the intervention is scheduled to occur over a 24-month period. The first results are expected to be submitted for publication in August 2021. CONCLUSIONS:With this report, we describe the study design, methods, and outcome measures that will be used in this ongoing clinical trial. Successful completion of the Improving Transplant Medication Safety through a Technology and Pharmacist Intervention study will provide empirical evidence of the effectiveness of a feasible and scalable technology-enabled intervention on improving medication safety and costs. CLINICAL TRIAL:ClinicalTrials.gov NCT03860818; https://clinicaltrials.gov/ct2/show/NCT03860818. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/13821.
| S-EPMC6774238 | biostudies-literature
Project description:BACKGROUND:In the field of health care, knowledge and clinical reasoning are key with regard to quality and confidence in decision making. The development of knowledge and clinical reasoning is influenced not only by students' intrinsic factors but also by extrinsic factors such as satisfaction with taught content, pedagogic resources and pedagogic methods, and the nature of the objectives and challenges proposed. Nowadays, professors play the role of learning facilitators rather than simple "lecturers" and face students as active learners who are capable of attributing individual meanings to their personal goals, challenges, and experiences to build their own knowledge over time. Innovations in health simulation technologies have led to clinical virtual simulation. Clinical virtual simulation is the recreation of reality depicted on a computer screen and involves real people operating simulated systems. It is a type of simulation that places people in a central role through their exercising of motor control skills, decision skills, and communication skills using virtual patients in a variety of clinical settings. Clinical virtual simulation can provide a pedagogical strategy and can act as a facilitator of knowledge retention, clinical reasoning, improved satisfaction with learning, and finally, improved self-efficacy. However, little is known about its effectiveness with regard to satisfaction, self-efficacy, knowledge retention, and clinical reasoning. OBJECTIVE:This study aimed to evaluate the effect of clinical virtual simulation with regard to knowledge retention, clinical reasoning, self-efficacy, and satisfaction with the learning experience among nursing students. METHODS:A randomized controlled trial with a pretest and 2 posttests was carried out with Portuguese nursing students (N=42). The participants, split into 2 groups, had a lesson with the same objectives and timing. The experimental group (n=21) used a case-based learning approach, with clinical virtual simulator as a resource, whereas the control group (n=21) used the same case-based learning approach, with recourse to a low-fidelity simulator and a realistic environment. The classes were conducted by the usual course lecturers. We assessed knowledge and clinical reasoning before the intervention, after the intervention, and 2 months later, with a true or false and multiple-choice knowledge test. The students' levels of learning satisfaction and self-efficacy were assessed with a Likert scale after the intervention. RESULTS:The experimental group made more significant improvements in knowledge after the intervention (P=.001; d=1.13) and 2 months later (P=.02; d=0.75), and it also showed higher levels of learning satisfaction (P<.001; d=1.33). We did not find statistical differences in self-efficacy perceptions (P=.9; d=0.054). CONCLUSIONS:The introduction of clinical virtual simulation in nursing education has the potential to improve knowledge retention and clinical reasoning in an initial stage and over time, and it increases the satisfaction with the learning experience among nursing students.
| S-EPMC6447149 | biostudies-literature
Project description:Statistical analysis plans increase the transparency of decisions made in the analysis of clinical trial results. The purpose of this paper is to detail the planned analyses for the PREVENT trial, a randomized, placebo-controlled trial of patient education for acute low back pain.We report the pre-specified principles, methods, and procedures to be adhered to in the main analysis of the PREVENT trial data. The primary outcome analysis will be based on Mixed Models for Repeated Measures (MMRM), which can test treatment effects at specific time points, and the assumptions of this analysis are outlined. We also outline the treatment of secondary outcomes and planned sensitivity analyses. We provide decisions regarding the treatment of missing data, handling of descriptive and process measure data, and blinded review procedures.Making public the pre-specified statistical analysis plan for the PREVENT trial minimizes the potential for bias in the analysis of trial data, and in the interpretation and reporting of trial results.ACTRN12612001180808 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808).
| S-EPMC5537460 | biostudies-other