Effect of the iChoose Kidney decision aid in improving knowledge about treatment options among transplant candidates: A randomized controlled trial.

We previously developed a mobile- and web-based decision aid (iChoose Kidney) that displays individualized risk estimates of survival and mortality, for the treatment modalities of dialysis versus kidney transplantation. We examined the effect of iChoose Kidney on change in transplant knowledge and access to transplant in a randomized controlled trial among patients presenting for evaluation in three transplant centers. A total of 470 patients were randomized to standard transplantation education (control) or standard education plus iChoose Kidney (intervention). Change in transplant knowledge (primary outcome) among intervention versus control patients was assessed using nine items in pre- and postevaluation surveys. Access to transplant (secondary outcome) was defined as a composite of waitlisting, living donor inquiries, or transplantation. Among 443 patients (n = 226 intervention; n = 216 control), the mean knowledge scores were 5.1 ± 2.1 pre- and 5.8 ± 1.9 postevaluation. Change in knowledge was greater among intervention (1.1 ± 2.0) versus control (0.4 ± 1.8) patients (P < .0001). Access to transplantation was similar among intervention (n = 168; 74.3%) versus control patients (n = 153; 70.5%; P = .37). The iChoose Kidney decision aid improved patient knowledge at evaluation, but did not impact transplant access. Future studies should examine whether combining iChoose Kidney with other interventions can increase transplantation. (Clinicaltrials.gov NCT02235571).

Decisional conflict between treatment options among end-stage renal disease patients evaluated for kidney transplantation.

Although kidney transplantation provides a significant benefit over dialysis, many patients with end-stage renal disease (ESRD) are conflicted about their decision to undergo kidney transplant. We aimed to identify the prevalence and characteristics associated with decisional conflict between treatment options in ESRD patients presenting for transplant evaluation. Among a cross-sectional sample of patients with ESRD (n=464) surveyed in 2014 and 2015, we assessed decisional conflict through a validated 10-item questionnaire. Decisional conflict was dichotomized into no decisional conflict (score=0) and any decisional conflict (score>0). We investigated potential characteristics of patients with decisional conflict using bivariate and multivariable logistic regression. The overall mean age was 50.6 years, with 62% male patients and 48% African American patients. Nearly half (48.5%) of patients had decisional conflict regarding treatment options. Characteristics significantly associated with decisional conflict in multivariable analysis included male sex, lower educational attainment, and less transplant knowledge. Understanding characteristics associated with decisional conflict in patients with ESRD could help identify patients who may benefit from targeted interventions to help patients make informed, value-based, and supported decisions when deciding how to best treat their kidney disease.

Neonatal listeriosis in the UK 2004-2014.

OBJECTIVE: To define the clinical features and outcomes of neonatal listeriosis, and identify the maternal risk factors to seek scope for improvement. METHODS: Neonatal listeriosis was identified prospectively from a United Kingdom neonatal infection surveillance network (neonIN) between 2004 and 2014. The participating neonatal units completed a study-specific proforma. RESULTS: The incidence of neonatal listeriosis was 3.4 per 100,000 live births. Of the 21 cases identified, 19 were confirmed with a median gestational age of 33 weeks and a median birth weight of 1960 g. The majority had clinical features (95%, 18/19), presented within the first 24 h (95%, 18/19), and received penicillin empirically (94%, 18/19). The neonatal case-fatality rate was 21% (24% if probable cases were included). A proportion of mothers were investigated (60%, 12/18) and diagnosed with listeriosis (58%, 7/12); 32% (6/19) were treated with antibiotics but only 33% (6/12) included penicillin. DISCUSSION: Despite its rarity and the prompt and appropriate use of antibiotics neonatal listeriosis has a high case-fatality rate. There is room for improvement in the adherence to the empiric antibiotic choice for puerperal sepsis, according to the national guidelines as this, would target listeriosis. Strategies should be in place to prevent pregnancy-associated listeriosis in higher risk population.

A Randomized Controlled Trial of a Mobile Clinical Decision Aid to Improve Access to Kidney Transplantation: iChoose Kidney.

Kidney transplantation is the preferred treatment for patients with end-stage renal disease, as it substantially increases a patient's survival and is cost saving compared to a lifetime of dialysis. However, transplantation is not universally chosen by patients with renal failure, and limited knowledge about the survival benefit of transplantation vs. dialysis may play a role. We created a mobile application clinical decision aid called iChoose Kidney to improve access to individualized prognosis information comparing dialysis and transplantation outcomes. We describe the iChoose Kidney study, a randomized controlled trial designed to test the clinical efficacy of a mobile health decision aid among end-stage renal disease patients referred for kidney transplantation at three large, diverse transplant centers across the U.S. Approximately 450 patients will be randomized to receive either: (1) standard of care or "usual" transplantation education, or (2) standard of care plus iChoose Kidney. The primary outcome is change in knowledge about the survival benefit of kidney transplantation vs. dialysis from baseline to immediate follow-up; secondary outcomes include change in treatment preferences, improved decisional conflict, and increased access to kidney transplantation. Analyses are also planned to examine effectiveness across subgroups of race, socioeconomic status, health literacy and health numeracy. Engaging patients in health care choices can increase patient empowerment and improve knowledge and understanding of treatment choices. If the effectiveness of iChoose Kidney has a greater impact on patients with low health literacy, lower socioeconomic status, and minority race, this decision aid could help reduce disparities in access to kidney transplantation.

An efficacy trial of an electronic health record-based strategy to inform patients on safe medication use: The role of written and spoken communication.

OBJECTIVE: We tested the feasibility and efficacy of an electronic health record (EHR) strategy that automated the delivery of print medication information at the time of prescribing. METHODS: Patients (N=141) receiving a new prescription at one internal medicine clinic were recruited into a 2-arm physician-randomized study. We leveraged an EHR platform to automatically deliver 1-page educational 'MedSheets' to patients after medical encounters. We also assessed if physicians counseled patients via patient self-report immediately following visits. Patients' understanding was objectively measured via phone interview. RESULTS: 122 patients completed the trial. Most intervention patients (70%) reported receiving MedSheets. Patients reported physicians frequently counseled on indication and directions for use, but less often for risks. In multivariable analysis, written information (OR 2.78, 95% CI 1.10-7.04) and physician counseling (OR 2.95, 95% CI 1.26-6.91) were independently associated with patient understanding of risk information. Receiving both was most beneficial; 87% of those receiving counseling and MedSheets correctly recalled medication risks compared to 40% receiving neither. CONCLUSION: An EHR can be a reliable means to deliver tangible, print medication education to patients, but cannot replace the salience of physician-patient communication. PRACTICE IMPLICATIONS: Offering both written and spoken modalities produced a synergistic effect for informing patients.

Advancing Best Practices for Prescription Drug Labeling.

OBJECTIVE: Problematic prescription drug labeling has been cited as a root cause of patient misunderstanding, medication errors, and nonadherence. Although numerous studies have recently been conducted to identify and test labeling best practices, the last systematic review on this topic was conducted a decade ago. The objective of this review was, therefore, to examine, summarize, and update best practices for conveying written prescription medication information and instructions to patients. DATA SOURCES: English-language articles published from June 2005 to June 2015 were identified in MEDLINE and CINAHL by searching the following text words: 'medication OR prescription OR drug' AND 'label OR leaflet OR brochure OR pamphlet OR medication guide OR medication insert OR drug insert OR medication information OR drug information OR instructions' AND 'patient OR consumer.' Reference mining and secondary searches were also performed. STUDY SELECTION AND DATA EXTRACTION: A total of 31 articles providing evidence on how to improve written, prescription drug labeling for patient use were selected. Two reviewers independently screened articles, rated their quality, and abstracted data. DATA SYNTHESIS: Identified best practices included the use of plain language, improved formatting and organization, and more explicit instructions to improve patient comprehension. The use of icons had conflicting findings, and few studies tested whether practices improved knowledge or behaviors with patients' actual prescribed regimens. CONCLUSIONS: Future studies are needed to determine how specific modifications and improvements in drug labeling can enhance patient knowledge and behavior in actual use. Synthesizing best practices across all patient materials will create a more useful, coordinated system of prescription information.

Comparative effectiveness of patient-centered strategies to improve FDA medication guides.

BACKGROUND: Med Guides are the only Food and Drug Administration-regulated source of written patient information distributed with prescriptions drugs. Despite their potential value, studies have found them to have limited utility. OBJECTIVE: To evaluate the effectiveness of patient-centered strategies for the design of Med Guides to improve comprehension. DESIGN: A cross-sectional, randomized trial. SETTING: Two primary care clinics in Chicago, Illinois; one based in a public university hospital and the other within a private academic medical center. PATIENTS: A total of 1003 adults aged 18-85 years. INTERVENTION: The format and layout of content from 3 typical Med Guides (by reading difficulty, length, exposure) were modified several ways to promote information accessibility. Working with patients, the 3 most preferred versions were evaluated. The first used 2 columns to organize content (Column), a second mimicked over-the-counter "Drug Facts" labeling (Drug Facts), and the third followed health literacy best practices using a simple table format (Health Literacy prototype). MEASURES: Tailored comprehension assessment of content from 3 representative Med Guides. RESULTS: Comprehension was significantly greater for all 3 prototypes compared with the current standard (all P<0.001). The Health Literacy prototype consistently demonstrated the highest comprehension scores, and in multivariable analyses, outperformed both the Drug Facts [ß=-4.43, 95% confidence interval (CI), -6.21 to -2.66] and Column (ß=-4.04, 95% CI, -5.82 to -2.26) prototypes. Both older age (older than 60 y: ß=-10.54, 95% CI, -15.12 to -5.96), low and marginal literacy skills were independently associated with poorer comprehension (low: ß=-31.92, 95% CI, -35.72 to -28.12; marginal: ß=-12.91, 95% CI, -16.01 to -9.82). CONCLUSIONS: The application of evidence-based practices to the redesign of Med Guides significantly improved patient comprehension. Although some age and literacy disparities were reduced with the Health Literacy format in particular, both older age and low literacy remained independently associated with poorer comprehension. More aggressive strategies will likely be needed to gain assurances that all patients are informed about their prescribed medications. TRIAL REGISTRATION: Clinical Trials.Gov #NCT01731405.

Expanding the Universal Medication Schedule: a patient-centred approach.

OBJECTIVE: Improved drug labelling for chronic pill-form medications has been shown to promote patient comprehension, adherence and safety. We extended health literacy principles and included patients' perspectives to improve instructions for: (1) non-pill form, (2) short term, (3) 'as needed,' (4) tapered and (5) escalating dose medications. SETTING: Participants were recruited via convenience sampling from primary care clinics in Chicago, Illinois and San Francisco, California, USA. PARTICIPANTS: 40 adult, English-speaking participants who reported taking at least one prescription drug in the past 12 months were enrolled in the study. PRIMARY AND SECONDARY OUTCOMES: Participant opinions, preferences and comprehension of standard and improved medication instructions were assessed during four iterative waves of discussion groups. Brief interviews preceding the discussion groups measured individuals' literacy skills, sociodemographic and health characteristics. RESULTS: On average, participants were 46 years old, took four medications and reported two chronic health conditions. Patients varied sociodemographically; 40% were men and 33% had limited literacy skills. Patients agreed on the need for simpler terminology and specificity in instructions. Discussions addressed optimal ways of presenting numeric information, indication and duration of use information to promote comprehension and safe medication use. Consensus was reached on how to improve most of the instructions. CONCLUSIONS: Through this patient-centred approach, we developed a set of health literacy-informed instructions for more challenging medications. Findings can inform current drug labelling initiatives and promote safe and appropriate medication use.

Impact of electronic prescribing on medication use in ambulatory care.

OBJECTIVES: To investigate differences before and after rollout of electronic prescribing (e-prescribing) in (1) patients' primary adherence to newly prescribed medications, (2) patients' understanding of how to use their medications, and (3) multiple pharmacy use. STUDY DESIGN: Postvisit interviews and follow-up phone calls were done with 344 patients at an academic general internal medicine clinic. METHODS: Patient interviews and follow-up phone calls were done (1) before e-prescribing, (2) 1 to 6 months after e-prescribing, and (3) 12 to 18 months after e-prescribing. RESULTS: Overall, rates of abandoned prescriptions were 6.9% before e-prescribing, 10.6% 1 to 6 months after e-prescribing, and 2.5% 12 to 18 months after e-prescribing (P = .07). There was a reduction in awareness of the indication for a newly prescribed medicine among patients after e-prescribing (95.4%, 97.9%, and 89.8%, respectively; P = .03). There was a decrease in patients' ability to demonstrate proper use of their new medicine after e-prescribing (69.0% before e-prescribing, 67.1% 1-6 months after e-prescribing, 51.9% 12 -18 months after e-prescribing; P = .02). There was an increasing trend in the percentage of patients using multiple pharmacies after e-prescribing was implemented. CONCLUSIONS: We found both potential benefits and unexpected consequences as a result of the rollout of electronic prescribing. Adaptation to e-prescribing might be improved with outreach and education, including explicitly informing patients of the change during the first months of rollout. Tangible prescription information for reminder purposes only may also be beneficial.

Usability of FDA-approved medication guides.

BACKGROUND: Medication guides are required documents to be distributed to patients in order to convey serious risks associated with certain prescribed medicines. Little is known about the effectiveness of this information to adequately inform patients on safe use. OBJECTIVE: To examine the readability, suitability, and comprehensibility of medication guides, particularly for those with limited literacy. DESIGN: Assessments of suitability and readability of 185 medication guides, and a sub-study examining change in suitability and readability from 2006 to 2010 among 32 of the medication guides (Study 1); 'open book' comprehension assessment of medication guides (Study 2). SETTING: Two general internal medicine clinics in Chicago, IL. PATIENTS: Four hundred and forty-nine adults seeking primary care services, ages 18-85. MEASUREMENTS: For Study 1, the Suitability Assessment of Materials (SAM) and Lexile score for readability. For Study 2, a tailored comprehension assessment of content found in three representative medication guides. RESULTS: The 185 analyzed medication guides were on average 1923 words (SD = 1022), with a mean reading level of 10-11th grade. Only one medication guide was deemed suitable in SAM analyses. None provided summaries or reviews, or framed the context first, while very few were rated as having made the purpose evident (8 %), or limited the scope of content (22 %). For Study 2, participants' comprehension of medication guides was poor (M = 52.7 % correct responses, SD = 22.6). In multivariable analysis, low and marginal literacy were independently associated with poorer understanding (ß = -14.3, 95 % CI -18.0 - -10.6, p < 0.001; low: ß = -23.7, 95 % CI -28.3 - -19.0, p < 0.001). CONCLUSION: Current medication guides are of little value to patients, as they are too complex and difficult to understand especially for individuals with limited literacy. Explicit guidance is offered for improving these print materials.

Practicing paramedics cannot generate or estimate safe endotracheal tube cuff pressure using standard techniques.

OBJECTIVES: We sought to determine the ability of paramedics to inflate endotracheal tube cuffs within safe pressure limits as well as to estimate the pressure of previously inflated endotracheal tube cuffs by palpation of the pilot balloon. METHODS: Using a tracheal simulation model, we conducted a prospective, observational, cross-sectional simulation study of licensed, practicing paramedics. This included evaluation of their ability to inflate the cuff of an endotracheal tube to a safe pressure, defined as < or = 25 cm H(2)O, as well as to identify excessive intracuff pressure in previously inflated ETT cuffs by palpation of the pilot balloon. RESULTS: Fifty-three paramedics were sampled. The average pressure generated by inflating the endotracheal tube cuff was > 108 cm H(2)O. Participants were only 13% sensitive detecting over inflated endotracheal tube cuffs (95% CI 7.3-17.8). CONCLUSIONS: Participants were unable to inflate endotracheal tube cuff to safe pressures and were unable to identify endotracheal tube cuffs with excessive intracuff pressure by palpation. Clinicians should consider using devices such as manometers to facilitate safe inflation and accurate measurement of endotracheal tube cuff pressure.

Evaluating the performance of pelvic floor exercises in women with urinary incontinence.

OBJECTIVE: To evaluate the strength of pelvic floor muscles in women with urinary incontinence and to evaluate relief of symptoms using biofeedback therapy. STUDY DESIGN: Women complaining of urinary incontinence and reporting the ability to perform pelvic floor exercises participated in this 4-week clinical trial. Participants underwent evaluation with objective measurement, using a biofeedback software package. The degree of pelvic floor muscle isolation was measured at the initial visit, and participants were given a pelvic floor exercise regimen to continue at home. After 4 weeks, the participants underwent a second evaluation. The ratio of pelvic floor to rectal muscle use was calculated as an index used to determine if the exercises were performed correctly. Participants also rated their improvement in urinary incontinence on a 10-point scale. RESULTS: Twenty women completed the trial. The subjects' mean age was 62.85 +/- 8.89 years. Fifteen women (75.0%) performed the exercises correctly during the initial evaluation, and 5 performed them incorrectly. Four of these 5 subsequently performed them correctly after biofeedback teaching. The mean self-reported degree of urinary incontinence improvement was 6.6 (+/- 1.31) and rangedfrom 5 to 9. Six (40%) women reported no incontinence episodes during the trial. CONCLUSION: The majority of study participants reported improved bladder function after participating in a session of biofeedback training. Training objectively improved pelvicfloor exercises in the cohort who performed them incorrectly and improved urinary incontinence in the majority of subjects.