Impact of training and structured medication review on medication appropriateness and patient-related outcomes in nursing homes: results from the interventional study InTherAKT.

BACKGROUND: Uncoordinated interprofessional communication in nursing homes increases the risk of polypharmacy and inappropriate medication use. This may lead to augmented frequency of adverse drug events, hospitalizations and mortality. The aims of this study were (1) to improve interprofessional communication and medication safety using a combined intervention and thus, (2) to improve medication appropriateness and health-related outcomes of the included residents. METHODS: The single-arm interventional study (2014-2017) was conducted in Muenster, Germany and involved healthcare professionals and residents of nursing homes. The intervention consisted of systematic education of participating healthcare professionals and of a structured interprofessional medication review which was performed via an online communication platform. The primary endpoint was assessed using the Medication Appropriateness Index MAI. Secondary endpoints were: cognitive performance, delirium, agitation, mobility, number of drugs, number of severe drug-drug interactions and appropriateness of analgesics. Outcomes were measured before, during and after the intervention. Data were analyzed using descriptive and inference-statistical methods. RESULTS: Fourteen general practitioners, 11 pharmacists, 9 nursing homes and 120 residents (n = 83 at all testing times) participated. Overall MAI sum-score decreased significantly over time (mean reduction: -7.1, CI95% -11.4 - - 2.8; median = - 3.0; dCohen = 0.39), especially in cases with baseline sum-score ≥ 24 points (mean reduction: -17.4, CI95% -27.6 - - 7.2; median = - 15.0; dCohen = 0.86). MAI sum-score of analgesics also decreased (dCohen = 0.45). Mean number of severe drug-drug interactions rose slightly over time (dCohen = 0.17). The proportion of residents showing agitated behavior diminished from 83.9 to 67.8%. Remaining secondary outcomes were without substantial change. CONCLUSION: Medication appropriateness increased particularly in residents with high baseline MAI sum-scores. Cognitive decline of participating residents was seemingly decelerated when compared with epidemiologic studies. A controlled trial is required to confirm these effects. Interprofessional interaction was structured and performance of medication reviews was facilitated as the online communication platform provided unlimited and consistent access to all relevant and updated information. TRIAL REGISTRATION: DRKS Data Management, ID: DRKS00007900 , date of registration: 2015-09-02 (retrospectively registered i.e. 6 weeks after commencement of the first data collection).

Radial versus femoral access site for percutaneous coronary intervention in patients suffering acute myocardial infarction : A randomized prospective multicenter trial.

BACKGROUND: Transradial access (TRA) in percutaneous coronary intervention (PCI) is a widely used standard technique with lower complication rates compared to transfemoral access (TFA). The aim of this study was to evaluate the impact of TRA versus TFA for PCI on clinically significant vascular access complications in the setting of acute myocardial infarction (AMI). METHODS: This multicenter study randomly assigned 250 patients in a 1:1 fashion (TRA vs. TFA) admitted with or without ST-segment elevation AMI undergoing immediate PCI. The primary endpoint was defined as the occurrence of hematoma, pseudo-aneurysm or local bleeding at the access site requiring any further intervention and/or prolonged hospital stay. Radiation exposure to the patient and operator was also investigated. RESULTS: In the study cohort (N = 250 patients, mean age 62 ± 12.7 years, 76% males) 5 patients (2%) achieved the primary endpoint without a significant difference between groups, 4 out of 125 (3.2%) in the TFA group and 1 out of 125 (0.8%) in the TRA group (p = 0.17). Access site hematoma was significantly more frequent in the TFA group compared to the TRA group (24.8% vs. 8.8%, respectively; p < 0.0007). Local bleeding was only seen in the TFA group (3.2% vs. 0%, p = 0.04). Time intervals from admission to catheter laboratory to first balloon inflation were longer in the TRA compared to the TFA group (34 ± 17 min vs 29.5 ± 13 min, respectively; p = 0.018). Radiation exposure to the patient and operator was identical. CONCLUSION: The use of TRA was accompanied by lower rates of access site complications; however, the need for subsequent treatment or prolonged hospital stays was not observed using either of the two access approaches.

Effect of training and structured medication review on medication appropriateness in nursing home residents and on cooperation between health care professionals: the InTherAKT study protocol.

BACKGROUND: Pharmacotherapy in residents of nursing homes is critical due to the special vulnerability of this population. Medical care and interprofessional communication in nursing homes are often uncoordinated. As a consequence, polypharmacy and inappropriate medication use are common and may lead to hospitalizations and health hazards. The aim of this study is to optimize communication between the involved professional groups by specific training and by establishing a structured medication review process, and to improve medication appropriateness and patient-relevant health outcomes for residents of nursing homes. METHODS/DESIGN: The trial is designed as single-arm study. It involves 300 nursing home residents aged ≥ 65 years and the members of the different professional groups practising in nursing home care (15-20 general practitioners, nurses, pharmacists). The intervention consists of interprofessional education on safe medication use in geriatric patients, and a systematic interprofessional therapy check (recording, reviewing and adapting the medication of the participating residents by means of a specific online platform). The intervention period is divided into two phases; total project period is 3 years. Primary outcome measure is the change in medication appropriateness according to the Medication Appropriateness Index. Secondary outcomes are cognitive performance, occurrence of delirium, agitation, tendency of falls, total number of drugs, number of potentially dangerous drug-drug interactions and appropriateness of recorded analgesic therapy regimens according to the Medication Appropriateness Index. Data are collected at t0 (before the start of the intervention), t1 (after the first intervention period) and t2 (after the second intervention period). Cooperation and communication between the professional groups are investigated twice by qualitative interviews. DISCUSSION: The project aims to establish a structured system for monitoring of drug therapy in nursing home residents. The newly developed online platform is designed to systematize and to improve the communication between the professional groups and, thus, to enhance quality and safety of drug therapy. Limitations of the study are the lack of a control group and the non-randomly recruited study sample. TRIAL REGISTRATION: DRKS Data Management, DRKS-ID: DRKS00007900.

Adverse Drug Event Monitoring with Clinical and Laboratory Data Using Arden Syntax.

In times of steadily increasing numbers of administered drugs, the detection of adverse drug events (ADEs) is an important aspect of improving patient safety. At present only about 1-13% of detected ADEs are reported. Raising the number of reported ADEs will result in greater and more efficient support of pharmacovigilance. Potential ADE's must be identified early. In the iMedication system, which is a rule-based application, triggers are used for computerized detection of possible ADEs. Creating a pilot system, we defined the relevant use cases hyperkalemia, hyponatremia, renal failure, and over-anticoagulation; knowledge bases were implemented in Arden Syntax for each use case. The objective of these knowledge bases is to interpret patient-specific clinical data and generate notifications based on a calculated ADE risk score, which may indicate possible ADEs. This will permit appropriate monitoring of potential ADE situations over time in the interest of patient care, quality assurance, and pharmacovigilance.

Impact of strategies to reduce polypharmacy on clinically relevant endpoints: a systematic review and meta-analysis.

AIM: The aim of the present study was to explore the impact of strategies to reduce polypharmacy on mortality, hospitalization and change in number of drugs. METHODS: Systematic review and meta-analysis: a systematic literature search targeting patients ≥65 years with polypharmacy (≥4 drugs), focusing on patient-relevant outcome measures, was conducted. We included controlled studies aiming to reduce polypharmacy. Two reviewers independently assessed studies for eligibility, extracted data and evaluated study quality. RESULTS: Twenty-five studies, including 10 980 participants, were included, comprising 21 randomized controlled trials and four nonrandomized controlled trials. The majority of the included studies aimed at improving quality or the appropriateness of prescribing by eliminating inappropriate and non-evidence-based drugs. These strategies to reduce polypharmacy had no effect on all-cause mortality (odds ratio 1.02; 95% confidence interval 0.84, 1.23). Only single studies found improvements, in terms of reducing the number of hospital admissions, in favour of the intervention group. At baseline, patients were taking, on average, 7.4 drugs in both the intervention and the control groups. At follow-up, the weighted mean number of drugs was reduced (-0.2) in the intervention group but increased (+0.2) in controls. CONCLUSIONS: There is no convincing evidence that the strategies assessed in the present review are effective in reducing polypharmacy or have an impact on clinically relevant endpoints. Interventions are complex; it is still unclear how best to organize and implement them to achieve a reduction in inappropriate polypharmacy. There is therefore a need to develop more effective strategies to reduce inappropriate polypharmacy and to test them in large, pragmatic randomized controlled trials on effectiveness and feasibility.

Detecting, Monitoring, and Reporting Possible Adverse Drug Events Using an Arden-Syntax-based Rule Engine.

The detection of adverse drug events (ADEs) is an important aspect of improving patient safety. The iMedication system employs predefined triggers associated with significant events in a patient's clinical data to automatically detect possible ADEs. We defined four clinically relevant conditions: hyperkalemia, hyponatremia, renal failure, and over-anticoagulation. These are some of the most relevant ADEs in internal medical and geriatric wards. For each patient, ADE risk scores for all four situations are calculated, compared against a threshold, and judged to be monitored, or reported. A ward-based cockpit view summarizes the results.

Rehospitalization rates after transcatheter aortic valve implantation.

AIMS: Comorbidities pose a major challenge to screening, selection and follow-up of transcatheter aortic valve implantation (TAVI) patients as well as to the procedure itself. The aim of the present study was to assess cardiac and non-cardiac readmission rates besides clinical endpoint data in the first 50 patients of a single center TAVI programme. METHODS AND RESULTS: TAVI was performed using the transfemoral CoreValve system. Procedural success rate was 94%; intraprocedural mortality was 2%. 82% of the patients remained free of a combined safety endpoint at 30 days, and 76.1% remained free of a combined efficacy endpoint at six months (modified criteria of the Valve Academic Research Consortium). At six months, among all surviving patients, 10.3% had experienced readmissions for cardiac causes, and 43.6% had experienced readmissions for non-cardiac causes. Causes of non-cardiac readmissions showed a wide distribution over various medical disciplines, reflecting the high rate of comorbidities. Beyond six months until a predefined reference date (mean follow up 9.9 months), the probability of hospitalization fell by half (1.54 vs. 0.74 hospital days per patient per month), driven by a decrease of non-cardiac readmissions. Karnofsky score before and after TAVI yielded a significant and sustained improvement of performance status, as assessed retrospectively at reference date. CONCLUSION: The findings of the present study suggest that the high prevalence of comorbidities in high-risk TAVI patients results in a high rate of non-cardiac rehospitalizations during the first 6 months of follow-up. Despite this fact, improvement of global everyday performance following TAVI as perceived by the patients seems to be substantial.

Polypharmacy and inappropriate prescribing in elderly internal-medicine patients in Austria.

OBJECTIVE: The aim of the study was to assess the prevalence of polypharmacy and inappropriate drug use in elderly internal-medicine patients in one Austrian center and to define the impact of these and other identified predictors on the occurrence of adverse drug events. METHODS: All patients>or=75 years admitted to selected internal wards of a university hospital were included in a monocentric prospective cohort study over a period of three months. The pre-admission medication of the patients was analyzed with respect to appropriateness by a multidisciplinary team consisting of pharmacists and physicians trained in internal medicine. The medication was evaluated for the occurrence of adverse drug events. RESULTS: A total of 543 patients were analyzed (median age 82 years; 60.2% female). The mean number of drugs taken was 7.5+/-3.8, with women taking significantly more drugs than men (7.8 vs. 6.8, P=0.013). Overall, 58.4% of the patients fulfilled the given criteria for polypharmacy (>6 drugs). The following factors were associated with polypharmacy: female sex, need for nursing care, high number of discharge diagnoses and high Charlson comorbidity score. Unnecessary drugs were found prescribed in 36.3% of all patients, drugs to avoid (Beers criteria) in 30.1%, duplication in 7.6%, wrong dosage in 23.4% and possible drug-drug interactions in 65.8%. Adverse drug events were identified in 17.8% of the patients (97/543), among whom the adverse drug event was the reason for hospital admission in 56.7% of the cases and a drug-drug interaction was involved in 18.7%. Risk factors for adverse drug events were female sex, polymorbidity, renal dysfunction and inappropriate prescribing. CONCLUSION: Polypharmacy, inappropriate prescribing and adverse drug events were highly prevalent in a cohort of elderly internal-medicine patients in Austria. To improve drug safety in this high-risk population, appropriate prescribing might be more important than simply reducing the number of prescribed drugs.

Present treatment of acute myocardial infarction in patients over 75 years--data from the Berlin Myocardial Infarction Registry (BHIR).

AIMS: Guidelines issued by European and German cardiology societies clearly define procedures for treatment of acute myocardial infarction (AMI). These guidelines, however, are based on clinical studies in which older patients are underrepresented. Older patients, on the other hand, represent a large and growing portion of the infarction population. It was our goal in the present paper to analyse the present treatment of AMI patients over 75 years of age in the city of Berlin, Germany, with data gained from the Berlin Myocardial Infarction Registry (BHIR). METHODS: We prospectively collected data from 5079 patients (3311 men and 1768 women, mean age 65.6) with acute myocardial infarction who were treated in 25 hospitals in Berlin during the period 1999-2003. 1319 patients (25.9%) were older than 75 (mean age 82.5 years). RESULTS: Overall hospital mortality rate was 11.6%. In patients over 75, this rate was 23.9%; among the younger infarction population, it was 7.3%. In contrast to the younger AMI patients, the majority of those over 75 were female (62.5 vs 25.1% for the younger) and demonstrated a significantly higher frequency of all prognostically meaningful comorbidities (heart failure 14.4% vs. 3.5%; renal failure 11.5 vs 3.9%; diabetes 37.3 vs 24.3%). Clinical signs of severe infarction, moreover, were more common among the aged patients (pulmonary congestion 45.4 vs 19.7%; left bundle branch block 12.7 vs 3.6%). Pre-hospital time was prolonged (2.8 vs 2 h) and guideline-recommended therapy was applied significantly less frequently to AMI patients over 75 (reperfusion therapy 39.8 vs 71.7%, beta-blockers 62.8 vs 78.3%, statins 26.5 vs 45.5%). Multivariate analysis revealed the following factors to be independent predictors of hospital mortality in patients over 75: age (OR 1.05 per year), acute heart failure (OR 2.39), pre-hospital resuscitation (OR 10.6), cardiogenic shock (OR 2.73), pre-hospital delay >12 h (OR 1.68), and ST elevation in the first ECG (OR 2.09). Independent predictors of a favourable hospital course were as follows: admission to a hospital >600 beds (OR 0.64), reperfusion therapy (OR 0.63), early betablocker treatment (OR 0.46), and early application of ACE inhibitors (OR 0.48). CONCLUSION: Infarction patients over 75 have a very high hospital complication and mortality rate. They are typically treated with delay, and with less adherence to relevant guidelines than are younger patients. Reperfusion therapy, early administration of beta-blockers and ACE inhibitors, as well as admission to large medical centres are all factors that contribute to a favourable prognosis of high-aged AMI patients.