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Studying the impact of a medication use evaluation for polymedicated older patients by the community pharmacist (SIMENON): study protocol.

ABSTRACT: BACKGROUND:Aged polymedicated patients are particularly vulnerable for drug-related problems. A medication review aims to optimize the medication use of patients and improve health outcomes. In this study, the effect of a pharmacist-led medication use review is investigated for polymedicated ambulatory older patients with the aim of implementing this pharmaceutical care intervention across Belgium. METHODS:This article describes the study protocol of the SIMENON study and reports the results of the feasibility study, which aimed to test and optimize this study protocol. In the SIMENON intervention study, 75 Belgian community pharmacies each recruit 12 patients for a medication use review. For each patient, the identified drug-related problems and subsequent interventions are registered using the PharmDISC classification. In a subset of Dutch speaking patients, a pretest-posttest single group design is used to measure the impact of this review on patient related outcomes using questionnaires. The main outcome of the study is the type and number of drug-related problems and related interventions. A second outcome is the impact of the medication use review on adherence, objectively measured with dispensing data. Evolution in medication related quality of life is another outcome, measured with the Living with Medicines Questionnaire version 3. Other patient reported outcomes include adherence, self-management, patient satisfaction, fall incidents and use of emergency healthcare services. DISCUSSION:The findings of this study can provide data on the effectiveness of a medication use review in the Belgian primary care setting. Furthermore, it will provide insights in which patients benefit most of this intervention and therefore facilitate the implementation of medication review in Belgium. TRIAL REGISTRATION:ClinicalTrials.gov NCT03179722 . Retrospectively registered 7 June 2017.

SUBMITTER: Wuyts J

PROVIDER: S-EPMC6083518 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Studying the impact of a medication use evaluation for polymedicated older patients by the community pharmacist (SIMENON): study protocol.

Wuyts J J Maesschalck J J De Wulf I I Foubert K K Boussery K K De Lepeleire J J Foulon V V

BMC health services research 20180808 1

<h4>Background</h4>Aged polymedicated patients are particularly vulnerable for drug-related problems. A medication review aims to optimize the medication use of patients and improve health outcomes. In this study, the effect of a pharmacist-led medication use review is investigated for polymedicated ambulatory older patients with the aim of implementing this pharmaceutical care intervention across Belgium.<h4>Methods</h4>This article describes the study protocol of the SIMENON study and reports ...[more]

PMID: 30089523

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Project description:IntroductionOptimal medication management is one of the basic conditions necessary for home-dwelling older adults living with multiple chronic conditions (OAMCC) to be able to remain at home and preserve their quality of life. Currently, the reasons for such high numbers of emergency department visits and the very significant rate of hospitalisations for OAMCC, due to medication-related problems (MRPs), is poorly explored. This study aims to reveal the current state of the medication management practices of polymedicated, home-dwelling OAMCC and to make proposals for improving clinical and medication pathways through an innovative and integrated model for supporting medication management and preventing adverse health outcomes.Methods and analysisA mixed-methods study will address the medication management of polymedicated, home-dwelling OAMCC. Its explanatory sequential design will involve two major phases conducted sequentially over time. The quantitative phase will consist of retrospectively exploiting the last 5 years of electronic patient records from a local hospital (N ≈ 50 000) in order to identify the different profiles-made up of patient-related, medication-related and environment-related factors-of the polymedicated, home-dwelling OAMCC at risk of hospitalisation, emergency department visits, hospital readmission (notably for MRPs), institutionalisation or early death. The qualitative study will involve: (a) obtaining and understanding the medication management practices and experiences of the identified profiles extracted from the hospital data of OAMCC who will be interviewed at home (N ≈ 30); (b) collecting and analysing the perspectives of the formal and informal caregivers involved in medication management at home in order to cross-reference perspectives about this important dimension of care at home. Finally, the mixed-methods findings will enable the development of an innovative, integrated model of medication management based on the Agency for Clinical Innovation framework and Bodenheimer and Sinsky's quadruple aim.Ethics and disseminationEthical approval has been obtained from the Human Research Ethics Committee of the Canton Vaud (2018-02196). Findings will be disseminated in peer-reviewed journals, professional conferences and other knowledge transfer activities with primary healthcare providers, hospital care units, informal caregivers' and patients' associations.

Project description:Many older adults take benzodiazepines and sedative-hypnotics for the treatment of sleep disorders. With a view to considering the possible discontinuation of hypnotics, the objectives of the present study were to describe bedtime habits and sleep patterns in older adults and to identify the sleep medications taken. An expert group developed a structured interview guide for assessing the patients' bedtime habits, sleep patterns, and medications. During an internship in a community pharmacy, 103 sixth-year pharmacy students conducted around 10 interviews each with older adults (aged 65 or over) complaining of sleep disorders and taking at least one of the following medications: benzodiazepines, benzodiazepine derivatives ("Z-drugs"), antihistamines, and melatonin. A prospective, observational study was carried out from 4 January to 30 June 2016. The pharmacy students performed 960 interviews (with 330 men and 630 women; mean ± standard deviation age: 75.1 ± 8.8). The most commonly taken hypnotics were the Z-drugs zolpidem (n = 465, 48%) and zopiclone (n = 259, 27%). The vast majority of patients (n = 768, 80%) had only ever taken a single hypnotic medication. The median [interquartile range] prescription duration was 120 (48-180) months. About 75% (n = 696) of the patients had at least 1 poor sleep habit, and over 41% (n = 374) had 2 or more poor sleep habits. A total of 742 of the patients (77%) reported getting up at night-mainly due to nycturia (n = 481, 51%). Further, 330 of the patients (35%) stated that they were keen to discontinue their medication, of which 96 (29%) authorized the pharmacist to contact their family physician and discuss discontinuation. In France, pharmacy students and supervising community pharmacists can identify problems related to sleep disorders by asking simple questions about the patient's sleep patterns. Together with family physicians, community pharmacists can encourage patients to discuss their hypnotic medications.

Project description:Medication safety for older persons represents an ongoing challenge. Inappropriate prescriptions--those with a high risk of evidence-based harm--persist in up to 25% of seniors, and account for a significant proportion of avoidable emergency department visits. This project is the sequel to the EMPOWER study, in which a novel consumer-targeted written knowledge transfer tool aimed at empowering older adults to act as drivers of benzodiazepine de-prescription resulted in a 27% reduction of inappropriate benzodiazepine use at 6-month follow-up (number needed to treat (NNT)?= 4). Failure to discontinue in the EMPOWER study was attributable to re-emerging symptoms among participants, prescribing inertia, and lack of knowledge and skills for substituting alternate therapy among physicians and pharmacists. To maximize de-prescription of inappropriate therapy, educational medication-risk reduction initiatives should be tested that simultaneously include patients, physicians and pharmacists. The objective of this trial is to: 1) test the beneficial effect of a new de-prescribing paradigm enlisting pharmacists to transfer knowledge to both patients and prescribers in a 2-pronged approach to reduce inappropriate prescriptions, compared to usual care and 2) evaluate the transferability of the EMPOWER study concept to other classes of inappropriate prescriptions.We intend to conduct a 3-year pragmatic cluster randomized parallel-group controlled trial to test the effect of the new de-prescribing intervention compared to usual care for reducing 4 classes of inappropriate prescriptions from the 2012 Beers criteria among 450 community-dwelling older adults with polypharmacy. Inappropriate prescriptions will include benzodiazepines, sulfonylurea hypoglycemic agents, first generation antihistamines and non-steroidal anti-inflammatory drugs. The study population is community-dwelling older adults recruited from community pharmacies in Quebec, Canada. The intervention was developed based on a systematic review of the evidence for each medication. Participants in the experimental group will receive the written educational program following randomization and have their pharmacist send their physicians an evidence-based pharmaceutical opinion to recommend de-prescription and be followed for a year. The control group will be wait-listed for 6 months.System change to effectively reduce medication risk among community-dwelling seniors requires a coordinated approach targeting physicians, pharmacists and patients. This trial will test the feasibility and effectiveness of a tripartite approach to de-prescribing.Registered via ClinicalTrials.gov on 31 January 2014, identifier: NCT02053194.

Project description:BackgroundMedication therapy management (MTM) is a service, most commonly provided by pharmacists, intended to identify and resolve medication therapy problems (MTPs) to enhance patient care. MTM is typically documented by the community pharmacist in an MTM vendor's web-based platform. These platforms often include integrated alerts to assist the pharmacist with assessing MTPs. In order to maximize the usability and usefulness of alerts to the end users (e.g., community pharmacists), MTM alert design should follow principles from human factors science. Therefore, the objectives of this study were to 1) evaluate the extent to which alerts for community pharmacist-delivered MTM align with established human factors principles, and 2) identify areas of opportunity and recommendations to improve MTM alert design.MethodsFive categories of MTM alerts submitted by community pharmacists were evaluated: 1) indication, 2) effectiveness; 3) safety; 4) adherence; and 5) cost-containment. This heuristic evaluation was guided by the Instrument for Evaluating Human-Factors Principles in Medication-Related Decision Support Alerts (I-MeDeSA) which we adapted and contained 32 heuristics. For each MTM alert, four analysts' individual ratings were summed and a mean score on the modified I-MeDeSA computed. For each heuristic, we also computed the percent of analyst ratings indicating alignment with the heuristic. We did this for all alerts evaluated to produce an "overall" summary of analysts' ratings for a given heuristic, and we also computed this separately for each alert category. Our results focus on heuristics where ?50% of analysts' ratings indicated the alerts aligned with the heuristic.ResultsI-MeDeSA scores across the five alert categories were similar. Heuristics pertaining to visibility and color were generally met. Opportunities for improvement across all MTM alert categories pertained to the principles of alert prioritization; text-based information; alarm philosophy; and corrective actions.ConclusionsMTM alerts have several opportunities for improvement related to human factors principles, resulting in MTM alert design recommendations. Enhancements to MTM alert design may increase the effectiveness of MTM delivery by community pharmacists and result in improved patient outcomes.

Project description:In 2010 the 'Polymedication Check' (PMC), a pharmacist-led medication review, was newly introduced to be delivered independently from the prescriber and reimbursed by the Swiss health insurances. This study aimed at evaluating the impact of this new cognitive service focusing on medicines use and patients' adherence in everyday life.This randomised controlled trial was conducted in 54 Swiss community pharmacies. Eligible patients used ?4 prescribed medicines over >3 months. The intervention group received a PMC at study start (T-0) and after 28 weeks (T-28) while the control group received only a PMC at T-28. Primary outcome measure was change in patients' objective adherence, calculated as Medication Possession Ratio (MPR) and Daily Polypharmacy Possession Ratio (DPPR), using refill data from the pharmacies and patient information of dosing. Subjective adherence was assessed as secondary outcome by self-report questionnaires (at T-0 and T-28) and telephone interviews (at T-2 and T-16), where participants estimated their overall adherence on a scale from 0-100%.A total of 450 patients were randomly allocated to intervention (N = 218, 48.4%) and control group (N = 232, 51.6%). Dropout rate was fairly low and comparable for both groups (N Int = 37 (17.0%), NCont = 41 (17.7%), p = 0.845). Main addressed drug-related problem (DRP) during PMC at T-0 was insufficient adherence to at least one medicine (N = 69, 26.7%). At T-28, 1020 chronic therapies fulfilled inclusion criteria for MPR calculation, representing 293 of 372 patients (78.8%). Mean MPR and adherence to polypharmacy (DPPR) for both groups were equally high (MPRInt = 88.3, SD = 19.03; MPRCont = 87.5, SD = 20.75 (p = 0.811) and DPPRInt = 88.0, SD = 13.31; DPPRCont = 87.5, SD = 20.75 (p = 0.906), respectively). Mean absolute change of subjective adherence between T-0 and T-2 was +1.03% in the intervention and -0.41% in the control group (p = 0.058). The number of patients reporting a change of their adherence of more than ±5 points on a scale 0-100% between T-0 and T-2 was significantly higher in the intervention group (NImprovement = 30; NWorsening = 14) than in the control group (NImprovement = 20; NWorsening = 24; p = 0.028).Through the PMC pharmacist were able to identify a significant number of DRPs. Participants showed high baseline objective adherence of 87.5%, providing little potential for improvement. Hence, no significant increase of objective adherence was observed. However, regarding changes in subjective adherence of more than ±5% the PMC showed a positive effect.Clinical trial registry database, NCT01739816; first entry on November 27, 2012.

Project description:BackgroundAdverse drug events are unintended and harmful events related to medication use. They are a leading cause of visits to the emergency department, unplanned admissions to hospital and death. Adverse drug events can be misdiagnosed in the emergency department, resulting in treatment delays. Our objective was to describe a process to evaluate the effect of pharmacist-led medication review in high-risk patients in the emergency department on the number of days these patients subsequently spent in hospital within 30 days of their index visit.MethodsWe describe the evaluation of a prospective multicentre quality improvement program. During the evaluation period, triage nurses will flag incoming patients to the emergency department at high risk for adverse drug events by applying a clinical decision rule consisting of 4 variables (comorbid conditions, antibiotic use within 7 days, medication changes within 28 days and age). Consecutive eligible patients will be enrolled in the study and systematically allocated to either a pharmacist-led medication review group or a control group. In the intervention group, pharmacists will collect best-possible medication histories, review the patient's medications for appropriateness and adverse drug events, and communicate the results of their medication review to patients, caregivers and physicians. In the control group, nurses will start medication reconciliation by collecting best-possible medication histories, and physicians will refer patients to onsite pharmacists for specific medication management questions as needed. Health outcomes will be assessed using anonymized data linkage to administrative health databases. The primary outcome will be the percent days spent in hospital over a 30-day period.InterpretationThis protocol describes the methods for evaluating the effect of pharmacist-led medication review in high-risk patients in the emergency department on use of health services, and highlights the methodological challenges that will be encountered. We plan to disseminate the results of this evaluation through articles published in peer-reviewed journals, presentations at scientific meetings and briefing notes to institutional, provincial and national stakeholders.

Project description:BackgroundIn hospital surgical wards, patients are at higher risk for medication errors, in part because physicians may not consider themselves sufficiently trained to prescribe medications. Hence, collaborative teamwork involving the pharmacist is needed.ObjectivesTo assess the impact of medication reconciliation directed by pharmacists on decreasing medication discrepancies after discharge from the surgical ward.MethodsPatients admitted to the surgical unit at a tertiary teaching hospital in Amman, Jordan, between July 2017 and July 2018 were selected and randomly assigned to either the control or the intervention group. Upon admission, the number and kinds of unintentional medication discrepancies were determined for both groups. Medication reconciliation was then provided to patients in the intervention group. The number of unintentional discrepancies was re-evaluated upon discharge for both groups. To assess differences between the control and intervention groups, the χ2 or Fisher exact test was used for categorical variables and an independent-sample t test for continuous data. A paired t test was conducted to determine whether the number of medication discrepancies was reduced as a result of pharmacists' recommendations.ResultsA total of 123 patients met the inclusion criteria, 61 in the intervention group and 62 in the control group. Discrepancies of omission and wrong dose constituted 41 (77%) of the 53 discrepancies in the intervention group and 25 (76%) of the 33 discrepancies in the control group. The number of unintentional discrepancies was significantly reduced from admission to discharge in both the intervention group (p = 0.002) and the control group (p = 0.007). Of 53 recommendations made by pharmacists, 20 (38%) were accepted by the treating physician, and all of these discrepancies were resolved.ConclusionsThis study sheds light on the existence of unintentional medication discrepancies upon admission for surgical patients, which may expose the patients to potential harm upon discharge from hospital. Additional studies with a larger sample size are needed to gain further insights on pharmacists' role in implementing medication reconciliation for surgical patients.

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Studying the impact of a medication use evaluation for polymedicated older patients by the community pharmacist (SIMENON): study protocol.

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Studying the impact of a medication use evaluation for polymedicated older patients by the community pharmacist (SIMENON): study protocol.

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