Effects of a pharmaceutical care intervention on clinical outcomes and patient adherence in coronary heart disease: the MIMeRiC randomized controlled trial.

BACKGROUND: In the treatment of coronary heart disease, secondary prevention goals are still often unmet and poor adherence to prescribed drugs has been suggested as one of the reasons. We aimed to investigate whether pharmaceutical care by a pharmacist at the cardiology clinic trained in motivational interviewing improves clinical outcomes and patient adherence. METHODS: This was a prospective, randomized, controlled, outcomes-blinded trial designed to compare pharmaceutical care follow-up with standard care. After standard follow-up at the cardiology clinic, patients in the intervention group were seen by a clinical pharmacist two to five times as required over seven months. Pharmacists were trained to use motivational interviewing in the consultations and they tailored their support to each patient's clinical needs and beliefs about medicines. The primary study end-point was the proportion of patients who reached the treatment goal for low-density lipoprotein cholesterol by 12 months after discharge. The key secondary outcome was patient adherence to lipid-lowering therapy at 15 months after discharge, and other secondary outcomes were the effects on patient adherence to other preventive drugs, systolic blood pressure, disease-specific quality of life, and healthcare use. RESULTS: 316 patients were included. The proportion of patients who reached the target for low-density lipoprotein cholesterol were 37.0% in the intervention group and 44.2% in the control group (P = .263). More intervention than control patients were adherent to cholesterol-lowering drugs (88 vs 77%; P = .033) and aspirin (97 vs 91%; P = .036) but not to beta-blocking agents or renin-angiotensin-aldosterone system inhibitors. CONCLUSIONS: Our intervention had no positive effects on risk factors for CHD, but it increased patient adherence. Further investigation of the intervention process is needed to explore the difference in results between patient adherence and medication effects. Longer follow-up of healthcare use and mortality will determine if the increased adherence per se eventually will have a meaningful effect on patient health. TRIAL REGISTRATION: ClinicalTrials.gov NCT02102503, 03/04/2014 retrospectively registered.

Web-based education of the elderly improves drug utilization literacy: A randomized controlled trial.

The aim of this study was to explore the effects of web-based education in the field of drug utilization on elderly individuals' knowledge of, concerns about and self-assessed understanding of drug utilization. The 260 included participants were randomized to a control group or an intervention group. To assess drug utilization literacy, we used a questionnaire containing 20 multiple-choice questions on drug utilization and ten statements about drug utilization (to which participants graded their response using a Likert scale: two about common concerns and eight about their self-assessed understanding of drug utilization). The Beliefs about Medicines Questionnaire-General was also used. The intervention group scored higher on the knowledge questions (p < 0.001) and on six of the eight statements about self-assessed understanding of drug utilization at the first check after 2 weeks (p < 0.05). At a second check 6 months later, the difference remained for the knowledge questions, but there was no difference in self-assessed understanding of drug utilization between the groups. There were no differences in the concerns about drug utilization or beliefs about medication at any time. We conclude that a web-based education can improve drug utilization literacy in elderly individuals and might contribute to the safer use of medications.

Limited evidence of benefits of patient operated intelligent primary care triage tools: findings of a literature review.

INTRODUCTION: There is consistent evidence that the workload in general practices is substantially increasing. The digitalisation of healthcare including the use of artificial intelligence has been suggested as a solution to this problem. We wanted to explore the features of intelligent online triage tools in primary care by conducting a literature review. METHOD: A systematic literature search strategy was formulated and conducted in the PubMed database and the Cochrane Library. Articles were selected according to inclusion/exclusion criteria. Results and data were systematically extracted and thematically analysed. 17 articles of that reported large multimethod studies or smaller diagnostic accuracy tests on clinical vignettes were included. Reviews and expert opinions were also considered. RESULTS: There was limited evidence on the actual effects and performance of triage tools in primary care. Several aspects can guide further development: concepts of system design, system implementation and diagnostic performance. The most important findings were: a need to formulate evaluation guidelines and regulations; their assumed potential has not yet been met; a risk of increased or redistribution of workloads and the available symptom checker systems seem overly risk averse and should be tested in real-life settings. CONCLUSION: This review identified several features associated with the design and implementation of intelligent online triage tools in a primary care context, although most of the investigated systems seemed underdeveloped and offered limited benefits. Current online triage systems should not be used by individuals who have reasonable access to traditional healthcare. Systems used should be strictly evaluated and regulated like other medical products.

e-Learning for the elderly on drug utilization: A pilot study.

This study explores the attitudes of elderly people to the use of electronic educational technology (e-learning) on drug utilization, with particular emphasis on the layout, usability, content, and level of knowledge in the tool. e-Learning modules were evaluated by a group of elderly people (aged ⩾65 years, n = 16) via a questionnaire comprising closed and open-ended questions. Both qualitative and quantitative analyses of the responses showed mostly positive reviews. The results indicate that the e-learning modules are a suitable tool for distributing information and education and that they can be managed by elderly individuals who are familiar with computers, allowing them to learn more about medication use.

Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation.

BACKGROUND: Trials of complex interventions are often criticized for being difficult to interpret because the effects of apparently similar interventions vary across studies dependent on context, targeted groups, and the delivery of the intervention. The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a randomized controlled trial (RCT) of an intervention aimed at improving pharmacological secondary prevention. Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development of interventions, including descriptions of how the intervention is assumed to work, how this theory informed the process evaluation, and how the process evaluation relates to the outcome evaluation. OBJECTIVE: This paper aims to describe how the intervention was designed and developed. The aim of the process evaluation is to better understand how and why the intervention in the MIMeRiC trial was effective or not effective. METHODS: The research questions for evaluating the process are based on the conceptual model of change processes assumed in the intervention and will be analyzed by qualitative and quantitative methods. Quantitative data are used to evaluate the medication review in terms of drug-related problems, to describe how patients' beliefs about medicines are affected by the intervention, and to evaluate the quality of motivational interviewing. Qualitative data will be used to analyze whether patients experienced the intervention as intended, how cardiologists experienced the collaboration and intervention, and how the intervention affected patients' overall experience of care after coronary heart disease. RESULTS: The development and piloting of the intervention are described in relation to the theoretical framework. Data for the process evaluation will be collected until March 2018. Some process evaluation questions will be analyzed before, and others will be analyzed after the outcomes of the MIMeRiC RCT are known. CONCLUSIONS: This paper describes the framework for the design of the intervention tested in the MIMeRiC trial, development of the intervention from the pilot stage to the complete trial intervention, and the framework and methods for the process evaluation. Providing the protocol of the process evaluation allows prespecification of the processes that will be evaluated, because we hypothesize that they will determine the outcomes of the MIMeRiC trial. This protocol also constitutes a contribution to the new field of process evaluations as made explicit in health services research and clinical trials of complex interventions.

Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Protocol for a Randomized Controlled Trial Investigating Effects on Clinical Outcomes, Adherence, and Quality of Life.

BACKGROUND: Preventive treatment goals for blood pressure and cholesterol levels continue to be unmet for many coronary patients. The effect of drug treatment depends on both its appropriateness and the patients' adherence to the treatment regimen. There is a need for adherence interventions that have a measurable effect on clinical outcomes. OBJECTIVE: This study aims to evaluate the effects on treatment goals of an intervention designed to improve patient adherence and treatment quality in secondary prevention of coronary heart disease. A protocol for the prespecified process evaluation of the trial is published separately. METHODS: The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a prospective, randomized, outcomes-blinded trial designed to compare individualized follow-up by a clinical pharmacist using motivational interviewing (MI) and medication review with standard follow-up. Patients were randomized to 2 groups after stratification according to their beliefs about medicines. After standard follow-up at the cardiology clinic, patients in the intervention group are seen individually by a clinical pharmacist 2 to 5 times as required over 7 months, at the clinic. The pharmacist reviews each patient's medication and uses MI to manage any problems with prescribing and adherence. The primary study outcome is the proportion of patients who have reached the treatment goal for low-density lipoprotein cholesterol by 12 months after discharge. Secondary outcomes are the effects on patient adherence, systolic blood pressure, disease-specific quality of life, and health care use. RESULTS: The protocol for this study was approved by the Regional Ethics Committee, Linköping, in 2013. Enrollment started in October 2013 and ended in December 2016 when 417 patients had been included. Follow-up data collection will conclude in March 2018. Publication of the primary and secondary outcome results from the MIMeRiC trial is anticipated in 2019. CONCLUSIONS: The MIMeRiC trial will assess the effectiveness of an intervention involving medication reviews and individualized support. The results will inform the continued development of support for this large group of patients who use preventive medicines for lifelong treatment. The design of this adherence intervention is based on a theoretical framework and is the first trial of an intervention that uses beliefs about medicines to individualize the intervention protocol. TRIAL REGISTRATION: ClinicalTrials.gov NCT02102503; https://clinicaltrials.gov/ct2/show/NCT02102503 (Archived by WebCite at http://www.webcitation.org/6x7iUDohy).

Vital sign documentation in electronic records: The development of workarounds.

Workarounds are commonplace in healthcare settings. An increase in the use of electronic health records has led to an escalation of workarounds as healthcare professionals cope with systems which are inadequate for their needs. Closely related to this, the documentation of vital signs in electronic health records has been problematic. The accuracy and completeness of vital sign documentation has a direct impact on the recognition of deterioration in a patient's condition. We examined workflow processes to identify workarounds related to vital signs in a 372-bed hospital in Sweden. In three clinical areas, a qualitative study was performed with data collected during observations and interviews and analysed through thematic content analysis. We identified paper workarounds in the form of handwritten notes and a total of eight pre-printed paper observation charts. Our results suggested that nurses created workarounds to allow a smooth workflow and ensure patients safety.

Factors influencing the quality of vital sign data in electronic health records: A qualitative study.

AIMS AND OBJECTIVES: To investigate reasons for inadequate documentation of vital signs in an electronic health record. BACKGROUND: Monitoring vital signs is crucial to detecting and responding to patient deterioration. The ways in which vital signs are documented in electronic health records have received limited attention in the research literature. A previous study revealed that vital signs in an electronic health record were incomplete and inconsistent. DESIGN: Qualitative study. METHODS: Qualitative study. Data were collected by observing (68 hr) and interviewing nurses (n = 11) and doctors (n = 3), and analysed by thematic analysis to examine processes for measuring, documenting and retrieving vital signs in four clinical settings in a 353-bed hospital. RESULTS: We identified two central reasons for inadequate vital sign documentation. First, there was an absence of firm guidelines for observing patients' vital signs, resulting in inconsistencies in the ways vital signs were recorded. Second, there was a lack of adequate facilities in the electronic health record for recording vital signs. This led to poor presentation of vital signs in the electronic health record and to staff creating paper "workarounds." CONCLUSIONS: This study demonstrated inadequate routines and poor facilities for vital sign documentation in an electronic health record, and makes an important contribution to knowledge by identifying problems and barriers that may occur. Further, it has demonstrated the need for improved facilities for electronic documentation of vital signs. RELEVANCE TO CLINICAL PRACTICE: Patient safety may have been compromised because of poor presentation of vital signs. Thus, our results emphasised the need for standardised routines for monitoring patients. In addition, designers should consult the clinical end-users to optimise facilities for electronic documentation of vital signs. This could have a positive impact on clinical practice and thus improve patient safety.

Older Swedish Adults with High Self-Perceived Health Show Optimal 25-Hydroxyvitamin D Levels Whereas Vitamin D Status Is Low in Patients with High Disease Burden.

Controversy pervades the definition of adequate and optimal vitamin D status. The Institutes of Medicine have recommended serum 25(OH)D levels above 50 nmol/L based upon evidence related to bone health, but some experts, including the Endocrine Society and International Osteoporosis Foundation, suggest a minimum serum 25(OH)D level of 75 nmol/L to reduce the risk of falls and fractures in older adults. In a cross-sectional study, we compared vitamin D status in people ≥75 years selected from four groups with a frailty phenotype, combined with a control group free from serious illness, and who considered themselves completely healthy. Only 13% of the 169 controls were vitamin D deficient (S-25(OH)D) < 50 nmol/L), in contrast with 49% of orthopedic patients with hip fractures (n = 133), 31% of stroke patients (n = 122), 39% of patients visiting the hospital's emergency department ≥4 times a year (n = 81), and 75% of homebound adult residents in long-term care nursing homes (n = 51). The mean vitamin D concentration of the healthy control group (74 nmol/L) was similar to a suggested optimal level based on physiological data and mortality studies, and much higher than that of many officially recommended cut-off levels for vitamin D deficiency (<50 nmol/L). The present study provides a basis for planning and implementing public guidelines for the screening of vitamin D deficiency and vitamin D treatment for frail elderly patients.

Recording signs of deterioration in acute patients: The documentation of vital signs within electronic health records in patients who suffered in-hospital cardiac arrest.

Vital sign documentation is crucial to detecting patient deterioration. Little is known about the documentation of vital signs in electronic health records. This study aimed to examine documentation of vital signs in electronic health records. We examined the vital signs documented in the electronic health records of patients who had suffered an in-hospital cardiac arrest and on whom cardiopulmonary resuscitation was attempted between 2007 and 2011 (n = 228), in a 372-bed district general hospital. We assessed the completeness of vital sign data compared to VitalPAC™ Early Warning Score and the location of vital signs within the electronic health records. There was a noticeable lack of completeness of vital signs. Vital signs were fragmented through various sections of the electronic health records. The study identified serious shortfalls in the representation of vital signs in the electronic health records, with consequential threats to patient safety.

Potential drug-related problems detected by electronic expert support system: physicians' views on clinical relevance.

BACKGROUND: Drug-related problems cause suffering for patients and substantial costs. Multi-dose drug dispensing is a service in which patients receive their medication packed in bags with one unit for each dose occasion. The electronic expert support system (EES) is a clinical decision support system that provides alerts if potential drug-related problems are detected among a patients' current prescriptions, including drug-drug interactions, therapy duplications, high doses, drug-disease interactions, drug gender warnings, and inappropriate drugs and doses for geriatric or pediatric patients. OBJECTIVE: The aim of the study was to explore physicians' views on the clinical relevance of alerts provided by EES. Furthermore we investigated if physicians performed any changes in drug treatment following the alerts and if there were any differences in perceived relevance and performed changes between different types of alerts and drugs. SETTING: Two geriatric clinics and three primary care units in Sweden. METHOD: Prescribed medications for patients (n = 254) with multi-dose drug dispensing were analyzed for potential drug-related problems using EES. For each alert, a physician assessed clinical relevance and indicated any intended action. A total of 15 physicians took part in the study. Changes in drug treatment following the alerts were later measured. The relationship between variables was analyzed using Chi square test. MAIN OUTCOME MEASURE: Physicians' perceived clinical relevance of each alert, and changes in drug treatment following the alerts. RESULTS: Physicians perceived 68% (502/740) of EES alerts as clinically relevant and 11% of all alerts were followed by a change in drug treatment. Clinical relevance and likelihood to make changes in drug treatment was related to the alert category and substances involved in the alert. CONCLUSION: In most patients with multi-dose drug dispensing, EES detected potential drug-related problems, with the majority of the alerts regarded as clinically relevant and some followed by measurable changes in drug treatment.

Implementation of information systems at pharmacies - a case study from the re-regulated pharmacy market in Sweden.

BACKGROUND: When the Swedish pharmacy market was re-regulated in 2009, Sweden moved from one state-owned pharmacy chain to several private pharmacy companies, and four new dispensing systems emerged to replace the one system that had previously been used at all Swedish pharmacies for more than 20 years. OBJECTIVES: The aim of this case study was to explore the implementation of the new information systems for dispensing at pharmacies. METHODS: The vendors of the four dispensing systems in Sweden were interviewed, and a questionnaire was sent to the managers of the pharmacy companies. In addition, a questionnaire was sent to 350 pharmacists who used the systems for dispensing prescriptions. RESULTS: The implementation of four new dispensing systems followed a strict time frame set by political decisions, involved actors completely new to the market, lacked clear regulation and standards for functionality and quality assurance, was complex and resulted in variations in quality. More than half of the pharmacists (58%) perceived their current dispensing system as supporting safe dispensing of medications, 26% were neutral and 15% did not perceive it to support a safe dispensing. Most pharmacists (80%) had experienced problems with their dispensing system during the previous month. The pharmacists experienced problems included reliability issues, usability issues, and missing functionality. CONCLUSION: In this case study exploring the implementation of new information systems for dispensing prescriptions at pharmacies in Sweden, weaknesses related to reliability, functionality and usability were identified and could affect patient safety. The weaknesses of the systems seem to result from the limited time for the development and implementation, the lack of comprehensive and evidence-based requirements for dispensing systems, and the unclear distribution of quality assurance responsibilities among involved stakeholders.

Using advanced mobile devices in nursing practice--the views of nurses and nursing students.

Advanced mobile devices allow registered nurses and nursing students to keep up-to-date with expanding health-related knowledge but are rarely used in nursing in Sweden. This study aims at describing registered nurses' and nursing students' views regarding the use of advanced mobile devices in nursing practice. A cross-sectional study was completed in 2012; a total of 398 participants replied to a questionnaire, and descriptive statistics were applied. Results showed that the majority of the participants regarded an advanced mobile device to be useful, giving access to necessary information and also being useful in making notes, planning their work and saving time. Furthermore, the advanced mobile device was regarded to improve patient safety and the quality of care and to increase confidence. In order to continuously improve the safety and quality of health care, advanced mobile devices adjusted for nursing practice should be further developed, implemented and evaluated in research.

Implementation of a shared medication list: physicians' views on availability, accuracy and confidentiality.

BACKGROUND: Physicians, patients and others involved need to have accurate information on patients' current drug prescriptions available, and have that information protected from unauthorized access. During the past decade, many counties in Sweden have implemented regionally shared medication lists within health care. OBJECTIVE: The aim of this study was to describe physicians' views on changes in accuracy, availability and confidentiality in the transition from local medication lists to a regionally shared medication list. SETTING: Health care units in four different counties of Sweden after the transition from local medication lists to a regionally shared medication list. The shared medication list was an integrated part of the electronic health record system in the respective counties, but the system and implementation process varied. METHODS: Physicians (n = 7) with experience of transition from local medication lists to a regionally shared medication list were interviewed in a semi-structured manner. MAIN OUTCOME MEASURE: Physicians' views on changes in information risks, focusing on accuracy, availability and confidentiality. Results The transition from local medication lists to a shared medication list increased the availability of information: from being time consuming or not possible to access from other care givers to most information being available in one place. A regionally shared medication list was perceived as having the potential to provide a greater accuracy of information, but not always: the shared medication list was perceived as more complete but with more non-current drugs. On the other hand, a shared medication list implied an increased risk of violating patient privacy, placing greater demands on IT security in order to protect the confidentiality of information. CONCLUSION: Physicians perceived a regionally shared medication list to increase the availability of information about current prescriptions and potentially the accuracy but may decrease the confidentiality of information. To implement a shared medication list, we recommend providing clear description of responsibilities and routines for normal activities as well as back-up routines, consider IT-security and data protection early, involve patients to improve the accuracy of the list as well as to monitor and evaluate the implementation.

Trends in inappropriate drug therapy prescription in the elderly in Sweden from 2006 to 2013: assessment using national indicators.

BACKGROUND: Medication for elderly patients is often complex and problematic. Several criteria for classifying inappropriate prescribing exist. In 2010, the Swedish National Board of Health and Welfare published the document "Indicators of appropriate drug therapy in the elderly" as a guideline for improving prescribing for the elderly. OBJECTIVE: The aim of this study was to assess trends in the prescription of inappropriate drug therapy in the elderly in Sweden from 2006 to 2013 using national quality indicators for drug treatment. METHODS: Individual-based data on dispensed prescription drugs for the entire Swedish population aged ≥65 years during eight 3-month periods from 2006 to 2013 were accumulated. The data were extracted from the Swedish Prescribed Drug Register. Eight drug-specific quality indicators were monitored. RESULTS: For the entire population studied (n = 1,828,283 in 2013), six of the eight indicators showed an improvement according to the guidelines; the remaining two indicators (drugs with anticholinergic effects and excessive polypharmacy) remained relatively unchanged. For the subgroup aged 65-74 years, three indicators showed an improvement, four indicators remained relatively unchanged (e.g. propiomazine, and oxazepam) and one showed an undesirable trend (anticholinergic drugs) according to guidelines. For the older group (aged ≥75 years), all indicators except excessive polypharmacy showed improvement. CONCLUSION: According to the quality indicators used, the extent of inappropriate drug therapy in the elderly decreased from 2006 to 2013 in Sweden. Thus, prescribers appear to be more likely to change their prescribing patterns for the elderly than previously assumed.

Factors influencing the prescription of drugs of different price levels.

PURPOSE: Socioeconomic factors have been suggested to influence the prescribing of newer and more expensive drugs. In the present study, individual and health care provider factors were studied in relation to the prevalence of differently priced drugs. METHODS: Register data for dispensed drugs were retrieved for 18 486 individuals in a county council in Sweden. The prevalence of dispensed drugs was combined with data for the individual's gender, age, education, income, foreign background, and type of caregiver. For each of the diagnostic groups (chronic obstructive pulmonary disease [COPD], depression, diabetes, and osteoporosis), selected drugs were dichotomized into cost categories, lower and higher price levels. Univariate and multivariate logistic regressions were performed using cost category as the dependent variable and the individual and provider factors as independent variables. RESULTS: In all four diagnostic groups, differences were observed in the prescription of drugs of lower and higher price levels with regard to the different factors studied. Age and gender affected the prescription of drugs of lower and higher price levels more generally, except for gender in the osteoporosis group. Income, education, foreign background, and type of caregiver affected prescribing patterns but in different ways for the different diagnostic groups. CONCLUSIONS: Certain individual and provider factors appear to influence the prescribing of drugs of different price levels. Because the average price for the cheaper drugs versus more costly drugs in each diagnostic group was between 19% and 69%, there is a risk that factors other than medical needs are influencing the choice of drug.

Nursing students' experience of using a personal digital assistant (PDA) in clinical practice - an intervention study.

BACKGROUND: A personal digital assistant (PDA) is a multifunctional information and communication tool allowing nursing students to keep up to date with expanding health related knowledge. OBJECTIVES: This study was aimed at exploring nursing students' experience of using a PDA in clinical practice. METHOD: In this intervention study, nursing students (n=67) used PDAs during a period of 15 weeks, replied to questionnaires, and participated in focus group interviews. RESULTS: The PDA was found to support nursing students in clinical practice and to have the potential to be a useful tool with benefits for both the patients and for the students. The PDA was regarded as useful, and was presumed to imply increased confidence and time savings, and contribute to improved patient safety and quality of care. CONCLUSIONS: With available mobile technology, nursing students would be able to access necessary information, independent of time and place. Therefore, it is important that stakeholders and educators facilitate the use of PDAs to support nursing students during their clinical practice, in order to prepare them for their future work, and to continuously improve the safety and quality of healthcare.