Coordination of oral anticoagulant care at hospital discharge (COACHeD): pilot randomised controlled trial.

OBJECTIVES: To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home. DESIGN: Randomised, parallel design. SETTING: Medical wards at six hospital sites in southern Ontario, Canada. PARTICIPANTS: Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks. INTERVENTIONS: Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care. OUTCOMES MEASURES: Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation. RESULTS: Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62)). CONCLUSION: This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial. TRIAL REGISTRATION NUMBER: NCT02777047.

Coordination of Oral Anticoagulant Care at Hospital Discharge (COACHeD): protocol for a pilot randomised controlled trial.

BACKGROUND: Oral anticoagulants (OACs) are commonly prescribed, have well-documented benefits for important clinical outcomes but have serious harms as well. Rates of OAC-related adverse events including thromboembolic and hemorrhagic events are especially high shortly after hospital discharge. Expert OAC management involving virtual care is a research priority given its potential to reach remote communities in a more feasible, timely, and less costly way than in-person care. Our objective is to test whether a focused, expert medication management intervention using a mix of in-person consultation and virtual care follow-up, is feasible and effective in preventing anticoagulation-related adverse events, for patients transitioning from hospital to home. METHODS AND ANALYSIS: A randomized, parallel, multicenter design enrolling consenting adult patients or the caregivers of cognitively impaired patients about to be discharged from medical wards with a discharge prescription for an OAC. The interdisciplinary multimodal intervention is led by a clinical pharmacologist and includes a detailed discharge medication reconciliation and management plan focused on oral anticoagulants at hospital discharge; a circle of care handover and coordination with patient, hospital team and community providers; and early post-discharge follow-up virtual medication check-up visits at 24 h, 1 week, and 1 month. The control group will receive usual care plus encouragement to use the Thrombosis Canada website. The primary feasibility outcomes include recruitment rate, participant retention rates, trial resources management, and the secondary clinical outcomes include adverse anticoagulant safety events composite (AASE), coordination and continuity of care, medication-related problems, quality of life, and healthcare resource utilization. Follow-up is 3 months. DISCUSSION: This pilot RCT tests whether there is sufficient feasibility and merit in coordinating oral anticoagulant care early post-hospital discharge to warrant a full sized RCT. TRIAL REGISTRATION: NCT02777047.

Perceptions of patients and healthcare providers on patient education to improve oral anticoagulant management.

RATIONALE AND OBJECTIVES: Education of patients is thought to be key to high-quality oral anticoagulant (OAC) medication management. Theoretically, improving patients' knowledge should improve their self-management skills and adherence. The study's objective was to explore the opinions of healthcare providers and patients on the desired content and format of patient education on OACs, in addition to perceived barriers to high-quality patient education. METHODS: We applied qualitative descriptive methods in a focus group study on OAC management. Five focus group discussions were conducted in two health regions in Southwestern Ontario from 2017 to 2018 with 19 patients, 7 caregivers and 16 healthcare providers (physicians, nurses and pharmacists). During the focus groups, participants discussed their experiences with OAC education and made suggestions about the content and format for patient education on OACs. Transcripts were analysed using conventional content analysis. RESULTS: We identified the five themes of patient education on OAC management: content of OAC education (rationale, risk and appropriate drug administration methods), the best times for providing OAC education (time of OACs initiation along with continuing education), preferred education delivery strategies (case management targeted patient information summaries from authoritative sources such as Thrombosis Canada and video education), patient and community pharmacist engagement in OAC education, and perceived barriers to optimal patient education (patients depending too much on their healthcare providers for advice, the limited time patients spend with healthcare providers, gaps in clear communication between providers and the lack of a nationally or provincially coordinated OAC management programme). CONCLUSION: Our findings suggest that patients, caregivers and healthcare providers support the need for education on OACs, including for patients taking DOACs. Specific important content and proper education format are needed. The optimal combination of content, format, duration, timing and sources for OAC education requires further research.

Barriers and facilitators for optimizing oral anticoagulant management: Perspectives of patients, caregivers, and providers.

BACKGROUND: Oral anticoagulants (OACs) are very commonly prescribed for prevention of serious vascular events, but are also associated with serious medication-related bleeding. Mitigation of harm is believed to require high-quality OAC management. This study aimed to identify barriers and facilitators for optimal OAC management from the perspective of patients, caregivers and healthcare providers. METHODS: Using a qualitative descriptive study design, we conducted five focus groups, three with patients and caregivers and two with health care providers, in two health regions in Southwestern Ontario. An expert facilitator led the discussions using a semi-structured interview guide. Each session was digitally recorded, transcribed verbatim and anonymized. Transcripts were analyzed in duplicate using conventional content analysis. RESULTS: Forty-two (19 patients, 7 caregivers, and 16 providers including physicians, nurses and pharmacists) participated. More than half of the patients received OAC for the treatment of venous thromboembolism (57.9%) and the majority (94.7%) were on chronic therapy (defined as >3 years). Data analysis organized codes describing barriers and facilitators into 4 main themes-medication-related, patient-related, provider-related, and system-related. Barriers highlighted were problems with medication access due to cost, patient difficulties with adherence, knowledge and adjusting their lifestyles to OAC therapy, provider expertise, time for adequate communication amongst providers and their patients, and health care system inadequacies in supporting communications and monitoring. Facilitators identified generally addressed these barriers. CONCLUSIONS: Many barriers to optimal OAC management exist even in the era of DOACs, many of which are amenable to facilitators of improved care coordination, patient education, and adherence monitoring.

Evaluation of a Novel Audit Tool for Medication Reconciliation at Hospital Discharge.

BACKGROUND: Discharge medication reconciliation (MedRec) is designed to reduce medication errors and inform patients and key postdischarge providers, but it has been difficult to implement routinely in Canadian hospitals. OBJECTIVES: To evaluate and optimize a new discharge MedRec quality audit tool and to use it at 3 urban teaching hospitals. METHODS: The discharge MedRec quality audit tool, developed by the Canadian Patient Safety Institute and the Institute for Safe Medication Practices Canada, was assessed and modified to improve comprehensiveness, clarity, and quality. The modified tool was then used to evaluate the quality of the discharge MedRec process for adult patients discharged to home from the general internal medicine service at 3 academic hospitals. Postdischarge telephone interviews were conducted with consenting patients, their community pharmacists, and their family doctors. RESULTS: The audit tool required modification to include aspects of admission MedRec, high-risk medication discrepancies, and direct communication of discharge MedRec to key follow-up providers. Thirty-five patients (mean age 67.7 years, standard deviation [SD] 18.0 years; 17 [49%] women), with a mean of 8.8 (SD 4.5) prescribed medications at discharge, participated in the discharge MedRec evaluation. Documentation of any discharge MedRec was found for only 1 patient (3%), and no discharge MedRec was carried out by pharmacists. Postdischarge follow-up interviews elicited major gaps in communication with community pharmacists and with family physicians, which could lead to serious medication errors. CONCLUSIONS: The modified audit tool was useful for identifying gaps in the quality of discharge MedRec.

CONTEXTE: Le bilan comparatif des médicaments (BCM) au moment du congé est conçu pour réduire les erreurs médicamenteuses et informer les patients ainsi que les principaux prestataires de soins de santé après le congé, mais sa mise en oeuvre systématique dans les hôpitaux canadiens s'est heurtée à de grandes difficultés. OBJECTIFS: Évaluer et optimiser un nouvel outil d'évaluation de la qualité du BCM au moment du congé et l'utiliser dans trois hôpitaux universitaires urbains. MÉTHODES: Cet outil développé par l'Institut canadien pour la sécurité des patients (ICSP) et l'Institut pour la sécurité des médicaments aux patients du Canada (ISMP) a fait l'objet d'une évaluation et d'une modification visant à améliorer son exhaustivité, sa clarté et sa qualité. L'outil modifié a ensuite servi à évaluer la qualité du processus du BCM pour des patients adultes ayant obtenu leur congé après un séjour dans un service général de médecine interne dans trois hôpitaux universitaires. Des entretiens téléphoniques après le congé ont été menés avec les patients consentants, leur pharmacien communautaire et leur médecin de famille. RÉSULTATS: L'outil d'évaluation a dû être modifié pour inclure le BCM au moment de l'admission, des écarts de médication à haut risque et une communication directe du BCM aux prestataires de soins de santé principaux chargés du suivi après le congé. Trente-cinq patients (âge moyen: 67,7 ans; écart type [ET] 18 ans; 17 [49 %] femmes), chacun ayant reçu en moyenne 8,8 (ET 4,5) médicaments prescrits, ont participé à l'évaluation du BCM au congé de l'hôpital. Au moment du congé, on n'a trouvé de renseignements relatifs au BCM que pour un seul patient (3 %) et aucun BCM n'avait été préparé par les pharmaciens. Le suivi après le congé a généré des écarts de communication importants entre les pharmaciens communautaires et les médecins de famille, ce qui pourrait entraîner des erreurs médicamenteuses importantes. CONCLUSIONS: L'outil d'évaluation modifié a été utile pour déterminer les écarts relatifs à la qualité du BCM au moment du congé.

Comparative effectiveness and safety of oral anticoagulants for atrial fibrillation in real-world practice: a population-based cohort study protocol.

INTRODUCTION: Anticoagulants are arguably the most important drug family of all, based on the frequency and duration of their use, and the clinical importance and frequency of benefits and harms. Several direct acting oral anticoagulants (DOACs) have recently joined warfarin for the treatment of atrial fibrillation, with a resultant significant expansion in use of oral anticoagulants (OACs). Our objectives are to compare safety and effectiveness of DOACs versus warfarin in a full population where anticoagulation management is good and to identify which types of patients do better with DOACs versus warfarin and vice versa. METHODS AND ANALYSIS: This is a retrospective cohort study of all adults living in British Columbia who have a diagnosis of atrial fibrillation in hospital or medical service data, and a first prescription for an OAC. Coprimary outcomes are ischaemic stroke and systemic embolism (benefit) and major bleeding (harm). Secondary outcomes include net clinical benefit (composite of stroke, systemic embolism, major bleeds, myocardial infarction, pulmonary embolism and death), drug discontinuation and individual composite item occurrence. We will estimate the effects of treatment in a 2-year follow-up period, using time-to-event models with propensity score adjustment to control confounding. Secondary analyses will examine 'as treated' outcomes. ETHICS AND DISSEMINATION: The protocol, data creation plan, privacy impact statement and data sharing agreements have been approved. Dissemination is planned via conferences and publications as well as directly to drug policy leaders. Information on the overall comparative effectiveness and safety of DOACs versus warfarin in a country with high quality anticoagulation management, as well as for vulnerable subgroups, will be an important addition to the literature.

Management of Hospital Formularies in Ontario: Challenges within a Local Health Integration Network.

BACKGROUND: Expenditures on drugs dispensed and administered to patients in Canadian hospitals have been estimated at $2.4 billion per year. Pharmacy and therapeutics (P&T) committees play a key role in the evaluation and management of drug therapies in this setting. Hospitals differ with respect to the composition of these committees, their members' expertise, and the processes used for making formulary decisions. OBJECTIVES: To examine the current processes for formulary drug review from the perspective of P&T committees and their individual members, and to examine the needs and preferences of these stakeholders related to evidence review and potential collaborative drug review processes within a large Local Health Integration Network (LHIN) in Ontario. METHODS: Twenty-three sites within 10 hospital corporations in LHIN 4 (Hamilton Niagara Haldimand Brant) were recruited. A 2-part questionnaire was developed and pretested for clarity and comprehensiveness. The institution profile section of the questionnaire was to be completed by pharmacy directors and the P&T section by committee members. RESULTS: Ten pharmacy directors and 28 committee members representing 10 P&T committees responded. A mean of 6.4 new drug requests were reviewed annually by each P&T committee. Across the LHIN, the workload associated with reviewing submissions for new drugs to be added to the formulary represented 0.84 full-time equivalent. The quality of clinical evidence in the drug submissions was rated more favourably than the quality of economic evidence; furthermore, the use of economic evidence was limited by a lack of health economics expertise within the committees. A centralized review process for the LHIN was perceived as beneficial to improve efficiency, the quality of review, and standardization, and also to reduce costs. CONCLUSIONS: Across the Hamilton Niagara Haldimand Brant LHIN, considerable time and resources are spent on the review of potential new drugs for addition to the hospitals' formularies. A standardized formulary review process, with greater use of provincial and national drug reviews, would likely benefit all LHINs.

CONTEXTE: Les dépenses pour les médicaments distribués et administrés aux patients dans les hôpitaux canadiens ont été évaluées à 2,4 milliards de dollars par année. Les comités de pharmacologie et de thérapeutique jouent un rôle central dans l'analyse et la prise en charge des pharmacothérapies dans ce milieu. La composition de ces comités et l'expertise de leurs membres varient d'un hôpital à l'autre, tout comme les processus qui y sont employés pour prendre des décisions à propos de la liste des médicaments. OBJECTIFS: Étudier les processus actuels d'ajout de médicaments à la liste locale du point de vue des comités de pharmacologie et de thérapeutique et de leurs membres. Examiner les besoins et préférences de ces parties prenantes quant à l'analyse des données probantes et aux potentiels processus collaboratifs d'évaluation des médicaments au sein d'un important réseau local d'intégration des services de santé (RLISS) ontarien. MÉTHODES: Vingt-trois établissements dans 10 organisations hospitalières du RLISS 4 (Hamilton Niagara Haldimand Brant) ont été retenus. On a élaboré un questionnaire de deux parties qui a été testé au préalable pour en vérifier la clarté et l'exhaustivité. La section sur le profil de l'établissement devait être remplie par les directeurs de pharmacie et celle sur la pharmacologie et la thérapeutique devait l'être par les membres des comités. RÉSULTATS: Dix directeurs de pharmacie et 28 membres représentant 10 comités de pharmacologie et de thérapeutique ont répondu. En moyenne, 6,4 nouvelles demandes d'ajout de médicament étaient analysées annuellement par chaque comité. Dans l'ensemble du RLISS, la charge de travail nécessaire à l'analyse des demandes d'ajout de nouveaux médicaments à la liste locale représentait 0,84 d'un poste équivalent temps plein. La qualité des données cliniques probantes dans les demandes d'ajout était considérée plus favorablement que celle des données économiques. De plus, comme les membres des comités ne possédaient pas l'expertise nécessaire en économie de la santé, l'utilisation des données probantes à ce sujet était limitée. Un processus centralisé d'analyse pour le RLISS était perçu comme avantageux pour améliorer l'efficience, la qualité de l'analyse et la normalisation ainsi que pour réduire les coûts. CONCLUSIONS: Dans l'ensemble du RLISS de Hamilton Niagara Haldimand Brant, beaucoup de ressources et de temps sont accordés à évaluer l'ajout de médicaments à la liste locale. Tous les RLISS tireraient sûrement profit d'un processus normalisé d'ajout à la liste locale des médicaments ainsi que d'une meilleure utilisation des évaluations réalisées par les organismes provinciaux et national.

Development and validation of a decision aid for choosing among antithrombotic agents for atrial fibrillation.

BACKGROUND: Multiple antithrombotic agents are available for stroke prevention in atrial fibrillation (AF). A decision aid can assist patients in making informed decisions that best serves their needs. OBJECTIVE: To validate a decision aid to assist patients in choosing between antithrombotic agents (antiplatelets, warfarin, direct-acting oral anticoagulants (DOACs)) for AF. METHODS: Patients (60years or older) were recruited for this prospective study. The decision aid presented descriptions related to AF, then charts portraying important outcomes for comparisons between 1) no treatment, aspirin and anticoagulants, 2) warfarin versus DOACs, and 3) DOAC versus DOAC. The primary outcome was confidence in making treatment decisions. The secondary outcomes included change in knowledge scores, ratings of clarity, helpfulness and comprehensiveness. RESULTS: Eighty-one patients (mean age 75.2 [SD 7.5], 77% taking an anticoagulant) participated. After using the decision aid, mean decisional conflict score was low at 7.2 [SD 10.8] on a scale from 1 to 100. Mean knowledge score (total possible 10) improved from 7.4 [SD 1.7] to 9.3 [SD 1.0] (p<0.001). The mean helpfulness score in making a treatment choice was high at 6.2 [SD 0.9] on a scale from 1 to 7. No participant found the decision aid difficult to understand. Information in the decision aid was rated as good or excellent in terms of clarity and comprehensiveness. CONCLUSIONS: Our decision aid addresses a key medication safety gap - assisting patients to participate in shared decisions about anticoagulation. Future research is required to evaluate how decision aids influence actual choices and clinical outcomes.

Process mapping evaluation of medication reconciliation in academic teaching hospitals: a critical step in quality improvement.

BACKGROUND: Medication reconciliation (MedRec) has been a mandated or recommended activity in Canada, the USA and the UK for nearly 10 years. Accreditation bodies in North America will soon require MedRec for every admission, transfer and discharge of every patient. Studies of MedRec have revealed unintentional discrepancies in prescriptions but no clear evidence that clinically important outcomes are improved, leading to widely variable practices. Our objective was to apply process mapping methodology to MedRec to clarify current processes and resource usage, identify potential efficiencies and gaps in care, and make recommendations for improvement in the light of current literature evidence of effectiveness. METHODS: Process engineers observed and recorded all MedRec activities at 3 academic teaching hospitals, from initial emergency department triage to patient discharge, for general internal medicine patients. Process maps were validated with frontline staff, then with the study team, managers and patient safety leads to summarise current problems and discuss solutions. RESULTS: Across all of the 3 hospitals, 5 general problem themes were identified: lack of use of all available medication sources, duplication of effort creating inefficiency, lack of timeliness of completion of the Best Possible Medication History, lack of standardisation of the MedRec process, and suboptimal communication of MedRec issues between physicians, pharmacists and nurses. DISCUSSION: MedRec as practised in this environment requires improvements in quality, timeliness, consistency and dissemination. Further research exploring efficient use of resources, in terms of personnel and costs, is required.

Physician and patient willingness to pay for electronic cardiovascular disease management.

OBJECTIVES: Cardiovascular disease (CVD) is an important target for electronic decision support. We examined the potential sustainability of an electronic CVD management program using a discrete choice experiment (DCE). Our objective was to estimate physician and patient willingness-to-pay (WTP) for the current and enhanced programs. METHODS: Focus groups, expert input and literature searches decided the attributes to be evaluated for the physician and patient DCEs, which were carried out using a Web-based program. Hierarchical Bayes analysis estimated preference coefficients for each respondent and latent class analysis segmented each sample. Simulations were used to estimate WTP for each of the attributes individually and for an enhanced vascular management system. RESULTS: 144 participants (70 physicians, 74 patients) completed the DCE. Overall, access speed to updated records and monthly payments for a nurse coordinator were the main determinants of physician choices. Two distinctly different segments of physicians were identified - one very sensitive to monthly subscription fee and speed of updating the tracker with new patient data and the other very sensitive to the monthly cost of the nurse coordinator and government billing incentives. Patient choices were most significantly influenced by the yearly subscription cost. The estimated physician WTP was slightly above the estimated threshold for sustainability while the patient WTP was below. CONCLUSION: Current willingness to pay for electronic cardiovascular disease management should encourage innovation to provide economies of scale in program development, delivery and maintenance to meet sustainability thresholds.

What do Canadians think about physician-pharmaceutical industry interactions?

BACKGROUND: Many health professional and regulatory groups have guidelines for identifying, disclosing and managing potential conflicts of interest (COI). The opinions of the Canadian public regarding what constitutes COI are unknown. METHODS: Bilingual telephone survey in all provinces using a validated questionnaire on public opinions on physician-pharmaceutical industry interactions (POPPII). Adults 18 years or older were contacted using random digit dialing (RDD) with representative national sampling of households. Results were analyzed for predictors of opinions and were compared with the reference COI guideline. Two follow-up focus groups were held. RESULTS: 1041 participants (56.8% female, mean age 52.6 years (SD 16.5), 18.2% francophone, 57.7% with post-secondary education) completed the survey. 34.0% reported a prior concern about physician-pharmaceutical industry relationships. Acceptability of interactions varied from high for requesting information about a particular drug or small gifts of obvious educational value to the patient, to mixed for free meals to listen to pharmaceutical industry personnel or payment to attend a conference, to low for research recruitment fees, personal use of medication samples or for using information not yet public about a new drug to make investment decisions. Age of the participant influenced ratings of acceptability. There was reasonable agreement (>60% participants) with only half of the related reference COI guideline statements. CONCLUSIONS: Public opinions on physician-pharmaceutical industry interactions differ depending on the scenario but suggest a significant level of concern regarding interactions involving direct financial benefit to physicians.

Cost-effectiveness of a shared computerized decision support system for diabetes linked to electronic medical records.

BACKGROUND: Computerized decision support systems (CDSSs) are believed to enhance patient care and reduce healthcare costs; however the current evidence is limited and the cost-effectiveness remains unknown. OBJECTIVE: To estimate the long-term cost-effectiveness of a CDSS linked to evidence-based treatment recommendations for type 2 diabetes. METHODS: Using the Ontario Diabetes Economic Model, changes in factors (eg, HbA1c) from a randomized controlled trial were used to estimate cost-effectiveness. The cost of implementation, development, and maintenance of the core dataset, and projected diabetes-related complications were included. The base case assumed a 1-year treatment effect, 5% discount rate, and 40-year time horizon. Univariate, one-way sensitivity analyses were carried out by altering different parameter values. The perspective was the Ontario Ministry of Health and costs were in 2010 Canadian dollars. RESULTS: The cost of implementing the intervention was $483,699. The one-year intervention reduced HbA1c by 0.2 and systolic blood pressure by 3.95 mm Hg, but increased body mass index by 0.02 kg/m², resulting in a relative risk reduction of 14% in the occurrence of amputation. The model estimated that the intervention resulted in an additional 0.0117 quality-adjusted life year; the incremental cost-effectiveness ratio was $160,845 per quality-adjusted life-year. CONCLUSION: The web-based prototype decision support system slightly improved short-term risk factors. The model predicted moderate improvements in long-term health outcomes. This disease management program will need to develop considerable efficiencies in terms of costs and processes or improved effectiveness to be considered a cost-effective intervention for treating patients with type 2 diabetes.

The effectiveness of integrated health information technologies across the phases of medication management: a systematic review of randomized controlled trials.

OBJECTIVE: The US Agency for Healthcare Research and Quality funded an evidence report to address seven questions on multiple aspects of the effectiveness of medication management information technology (MMIT) and its components (prescribing, order communication, dispensing, administering, and monitoring). MATERIALS AND METHODS: Medline and 11 other databases without language or date limitations to mid-2010. Randomized controlled trials (RCTs) assessing integrated MMIT were selected by two independent reviewers. Reviewers assessed study quality and extracted data. Senior staff checked accuracy. RESULTS: Most of the 87 RCTs focused on clinical decision support and computerized provider order entry systems, were performed in hospitals and clinics, included primarily physicians and sometimes nurses but not other health professionals, and studied process changes related to prescribing and monitoring medication. Processes of care improved for prescribing and monitoring mostly in hospital settings, but the few studies measuring clinical outcomes showed small or no improvements. Studies were performed most frequently in the USA (n=63), Europe (n=16), and Canada (n=6). DISCUSSION: Many studies had limited description of systems, installations, institutions, and targets of the intervention. Problems with methods and analyses were also found. Few studies addressed order communication, dispensing, or administering, non-physician prescribers or pharmacists and their MMIT tools, or patients and caregivers. Other study methods are also needed to completely understand the effects of MMIT. CONCLUSIONS: Almost half of MMIT interventions improved the process of care, but few studies measured clinical outcomes. This large body of literature, although instructive, is not uniformly distributed across settings, people, medication phases, or outcomes.

Shared electronic vascular risk decision support in primary care: Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III) randomized trial.

BACKGROUND: Computerized decision support systems (CDSSs) linked with electronic medical records (EMRs) are promoted as an effective means of improving patient care. However, very few high-quality studies are set in routine, community-based clinical care, and no consistent evidence of an effect on patient outcomes has been found. METHODS: A randomized controlled trial among EMR-using primary care practices in Ontario, Canada. Patients 55 years or older with previous vascular events, diabetes mellitus, hypertension, or hypercholesterolemia were randomized to the Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III) CDSS intervention or to usual care. The intervention included personally tailored electronic vascular risk monitoring and treatment advice shared between the physician and patient, risk calculation, and a clinical resource. The primary outcome was a composite score of 8 recommended process outcomes at 1 year. Data collectors were blinded to group allocation. Analysis used the intention-to-treat principle with multiple imputation for missing data. RESULTS: We randomized and included in the analysis 1102 patients in 49 community-based physician practices (53.4% female; mean age, 69.1 years; 28.0% with a previous vascular event). The intervention group (545 [49.5%]) had a significantly greater improvement in mean process composite, with a difference of 4.70 (P < .001) on a 27-point scale. Intervention patients had significantly higher odds of rating their continuity of care (4.18; P < .001) and their ability to improve their vascular health (3.07; P < .001) as improved. Despite this improvement, the clinical outcomes-vascular events, clinical variables, and quality of life-were not improved. CONCLUSION: Despite favorable reviews and important improvements in the complex processes required to reduce vascular risk, clinical outcomes remain unchanged.

Enabling medication management through health information technology (Health IT).

OBJECTIVES: The objective of the report was to review the evidence on the impact of health information technology (IT) on all phases of the medication management process (prescribing and ordering, order communication, dispensing, administration and monitoring as well as education and reconciliation), to identify the gaps in the literature and to make recommendations for future research. DATA SOURCES: We searched peer-reviewed electronic databases, grey literature, and performed hand searches. Databases searched included MEDLINE®, Embase, CINAHL (Cumulated Index to Nursing and Allied Health Literature), Cochrane Database of Systematic Reviews, International Pharmaceutical Abstracts, Compendex, Inspec (which includes IEEE Xplore), Library and Information Science Abstracts, E-Prints in Library and Information Science, PsycINFO, Sociological Abstracts, and Business Source Complete. Grey literature searching involved Internet searching, reviewing relevant Web sites, and searching electronic databases of grey literatures. AHRQ also provided all references in their e-Prescribing, bar coding, and CPOE knowledge libraries. METHODS: Paired reviewers looked at citations to identify studies on a range of health IT used to assist in the medication management process (MMIT) during multiple levels of screening (titles and abstracts, full text and final review for assignment of questions and data abstrction). Randomized controlled trials and cohort, case-control, and case series studies were independently assessed for quality. All data were abstracted by one reviewer and examined by one of two different reviewers with content and methods expertise. RESULTS: 40,582 articles were retrieved. After duplicates were removed, 32,785 articles were screened at the title and abstract phase. 4,578 full text articles were assessed and 789 articles were included in the final report. Of these, 361 met only content criteria and were listed without further abstraction. The final report included data from 428 articles across the seven key questions. Study quality varied according to phase of medication management. Substantially more studies, and studies with stronger comparative methods, evaluated prescribing and monitoring. Clinical decision support systems (CDSS) and computerized provider order entry (CPOE) systems were studied more than any other application of MMIT. Physicians were more often the subject of evaluation than other participants. Other health care professionals, patients, and families are important but not studied as thoroughly as physicians. These nonphysicians groups often value different aspects of MMIT, have diverse needs, and use systems differently. Hospitals and ambulatory clinics were well-represented in the literature with less emphasis placed on long-term care facilities, communities, homes, and nonhospital pharmacies. Most studies evaluated changes in process and outcomes of use, usability, and knowledge, skills, and attitudes. Most showed moderate to substantial improvement with implementation of MMIT. Economics studies and those with clinical outcomes were less frequently studied. Those articles that did address economics and clinical outcomes often showed equivocal findings on the effectiveness and cost-effectiveness of MMIT systems. Qualitative studies provided evidence of strong perceptions, both positive and negative, of the effects of MMIT and unintended consequences. We found little data on the effects of forms of medications, conformity, standards, and open source status. Much descriptive literature discusses implementation issues but little strong evidence exists. Interest is strong in MMIT and more groups and institutions will implement systems in the next decades, especially with the Federal Government's push toward more health IT to support better and more cost-effective health care. CONCLUSIONS: MMIT is well-studied, although on closer examination of the literature the evidence is not uniform across phases of medication management, groups of people involved, or types of MMIT. MMIT holds the promise of improved processes; clinical and economics studies and the understanding of sustainability issues are lacking.

Individualized electronic decision support and reminders to improve diabetes care in the community: COMPETE II randomized trial.

BACKGROUND: Diabetes mellitus is a complex disease with serious complications. Electronic decision support, providing information that is shared and discussed by both patient and physician, encourages timely interventions and may improve the management of this chronic disease. However, it has rarely been tested in community-based primary care. METHODS: In this pragmatic randomized trial, we randomly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care. The intervention involved shared access by the primary care provider and the patient to a Web-based, colour-coded diabetes tracker, which provided sequential monitoring values for 13 diabetes risk factors, their respective targets and brief, prioritized messages of advice. The primary outcome measure was a process composite score. Secondary outcomes included clinical composite scores, quality of life, continuity of care and usability. The outcome assessors were blinded to each patient's intervention status. RESULTS: We recruited sequentially 46 primary care providers and then 511 of their patients (mean age 60.7 [standard deviation 12.5] years). Mean follow-up was 5.9 months. The process composite score was significantly better for patients in the intervention group than for control patients (difference 1.27, 95% confidence interval [CI] 0.79-1.75, p < 0.001); 61.7% (156/253) of patients in the intervention group, compared with 42.6% (110/258) of control patients, showed improvement (difference 19.1%, p < 0.001). The clinical composite score also had significantly more variables with improvement for the intervention group (0.59, 95% CI 0.09-1.10, p = 0.02), including significantly greater declines in blood pressure (-3.95 mm Hg systolic and -2.38 mm Hg diastolic) and glycated hemoglobin (-0.2%). Patients in the intervention group reported greater satisfaction with their diabetes care. INTERPRETATION: A shared electronic decision-support system to support the primary care of diabetes improved the process of care and some clinical markers of the quality of diabetes care. (ClinicalTrials.gov trial register no. NCT00813085.).

Automated telephone reminder messages can assist electronic diabetes care.

Telephone reminder systems have been used to assist in the treatment of many chronic diseases. However, it is unclear if these systems can increase medication and appointment adherence in patients with diabetes without direct patient-provider telephone contact. We tested the feasibility of using an automated telephone reminder system (ATRS) to deliver reminder messages to 253 adults with diabetes enrolled in a randomized controlled trial. Eighty-four percent of the patients were able to register using voice recognition and at least one reminder was delivered to 95% of registered patients over a period of 7.5 months. None of the demographic features studied predicted a patient's ability to enroll or to receive reminder calls. At the end of the study, 63% of patients indicated that they wished to continue to receive ATRS calls. The level of system use as determined by the number of received reminder calls was not associated with a change in the number of physician visits or diabetes-related laboratory tests during follow-up. The clinical benefits and sustainability of ATRS remain unproven, but our results indicate that an automated reminder system can be effective for providing messages to a large group of older patients with diabetes.

Applying methodology to electronic medical record selection.

BACKGROUND: Given the potential for electronic medical records (EMRs) to influence every aspect of health care, there has been surprisingly little rigorous research applied to this emerging health technology. An initial phase of the COMPETE (computerization of medical practices for the enhancement of therapeutic efficacy) program, which investigates the impact of EMRs and electronic decision support on efficiency, quality of care and privacy concerns, developed and used a rigorous approach to EMR selection. METHODS: A multidisciplinary team with clinical, technical and research expertise led an eight-stage evaluation process with direct input from potential clinical users at each stage. An iterative sequence of review of EMR specifications and features, live product demonstrations, site visits, and negotiations with vendors led to a progressive narrowing of the field of eligible EMR systems. Final scoring was based on three main themes of clinical usability, data quality and vendor maturity issues. RESULTS: The field of eligible EMR systems was relatively easily narrowed to a few finalists. Determination of the important strengths and weaknesses of these systems' usability, data extraction capabilities and vendor viability, required the full suite of evaluation steps. Preferences varied amongst clinicians and between clinicians and technical specialists, particularly regarding the importance of user interface versus database issues. However, the final scoring process showed consensus amongst clinical and technical experts. CONCLUSION: A rigorous, multidisciplinary process is useful in EMR selection. While prolonged and laborious, it is transparent, enhances buy in and realism of expectations by multiple potential users and IT support staff and may, therefore, improve the ultimate success of any EMR implementation project.