Dataset Information

The electronic medication complete communication (EMC²) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.

ABSTRACT:

Background

Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs.

Objective

To evaluate the effectiveness of the Electronic Medication Complete Communication (EMC²) Strategy to promote safe medication use and reporting of ADEs in comparison to usual care.

Methods

The automated EMC² Strategy consists of: 1) provider alerts to counsel patients on medication risks, 2) the delivery of patient-friendly medication information via the electronic health record, and 3) an automated telephone assessment to identify potential medication concerns or ADEs. The study will take place in two community health centers in Chicago, IL. Adult, English or Spanish-speaking patients (N=1200) who have been prescribed a high-risk medication will be enrolled and randomized to the intervention arm or usual care based upon practice location. The primary outcomes of the study are medication knowledge, proper medication use, and reporting of ADEs; these will be measured at baseline, 4weeks, and three months. Intervention fidelity as well as barriers and costs of implementation will be evaluated.

Conclusions

The EMC² Strategy automates a patient-friendly risk communication and surveillance process to promote safe medication use while minimizing clinic burden. This trial seeks to evaluate the effectiveness and feasibility of this strategy in comparison to usual care.

SUBMITTER: Bailey SC

PROVIDER: S-EPMC5108675 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Publications

The electronic medication complete communication (EMC<sup>2</sup>) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.

Bailey Stacy Cooper SC Paasche-Orlow Michael K MK Adams William G WG Brokenshire Samantha A SA Hedlund Laura A LA Hickson Ryan P RP Oramasionwu Christine U CU Moore Amy L AL McCarthy Danielle M DM Curtis Laura M LM Kwasny Mary J MJ Wolf Michael S MS

Contemporary clinical trials 20161022

<h4>Background</h4>Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs.<h4>Objective</h4>To evaluate the effectiveness of the Electronic Medication ...[more]

PMID: 27777127

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Project description:In major depressive disorder (MDD), the traditional belief of a delayed onset of antidepressants' effects has lead to the concept of current guidelines that treatment durations should be between 3-8 weeks before medication change in case of insufficient outcome. Post hoc analyses of clinical trials, however, have shown that improvement usually occurs within the first 10-14 days of treatment and that such early improvement (Hamilton Depression Rating Scale [HAMD] decrease >or=20%) has a substantial predictive value for final treatment outcome. Even more important, non-improvement (HAMD decrease <20%) after 14 days of treatment was found to be highly predictive for a poor final treatment outcome.The EMC trial is a phase IV, multi-centre, multi-step, randomized, observer-blinded, actively controlled parallel-group clinical trial to investigate for the first time prospectively, whether non-improvers after 14 days of antidepressant treatment with an early medication change (EMC) are more likely to attain remission (HAMD-17 <or=7) on treatment day 56 compared to patients treated according to current guideline recommendation (treatment as usual; TAU). In level 1 of the EMC trial, non-improvers after 14 days of antidepressant treatment will be randomised to an EMC strategy or TAU. The EMC strategy for this study schedules a first medication change on day 15; in case of non-improvement between days 15-28, a second medication change will be performed. TAU schedules the first medication change after 28 days in case of non-response (HAMD-17 decrease <50%). Both interventions will last 42 days. In levels 2 and 3, EMC strategies will be compared with TAU strategies in improvers on day 14, who experience a stagnation of improvement during the course of treatment. The trial is supported by the German Federal Ministry of Education and Research (BMBF) and will be conducted in cooperation with the BMBF funded Interdisciplinary Centre Clinical Trials (IZKS) at the University Medical Centre Mainz and at six clinical trial sites in Germany.If the EMC strategies lead to significantly more remitters, changes of clinical practice, guidelines for the treatment of MDD as well as research settings can be expected.Clincaltrials.gov Identifier: NCT00974155; EudraCT: 2008-008280-96.

Project description:BackgroundPoor medication adherence is common; however, few mechanisms exist in clinical practice to monitor how patients take medications in outpatient settings.ObjectiveThis study aimed to pilot test the Electronic Medication Complete Communication (EMC2) strategy, a low-cost, sustainable approach that uses functionalities within the electronic health record to promote outpatient medication adherence and safety.MethodsThe EMC2 strategy was implemented in 2 academic practices for 14 higher-risk diabetes medications. The strategy included: (1) clinical decision support alerts to prompt provider counseling on medication risks, (2) low-literacy medication summaries for patients, (3) a portal-based questionnaire to monitor outpatient medication use, and (4) clinical outreach for identified concerns. We recruited adult patients with diabetes who were prescribed a higher-risk diabetes medication. Participants completed baseline and 2-week interviews to assess receipt of, and satisfaction with, intervention components.ResultsA total of 100 patients were enrolled; 90 completed the 2-week interview. Patients were racially diverse, 30.0% (30/100) had a high school education or less, and 40.0% (40/100) had limited literacy skills. About a quarter (28/100) did not have a portal account; socioeconomic disparities were noted in account ownership by income and education. Among patients with a portal account, 58% (42/72) completed the questionnaire; 21 of the 42 patients reported concerns warranting clinical follow-up. Of these, 17 were contacted by the clinic or had their issue resolved within 24 hours. Most patients (33/38, 89%) who completed the portal questionnaire and follow-up interview reported high levels of satisfaction (score of 8 or greater on a scale of 1-10).ConclusionsFindings suggest that the EMC2 strategy can be reliably implemented and delivered to patients, with high levels of satisfaction. Disparities in portal use may restrict intervention reach. Although the EMC2 strategy can be implemented with minimal impact on clinic workflow, future trials are needed to evaluate its effectiveness to promote adherence and safety.

Project description:BackgroundThe objective was to find evidence to substantiate assertions that electronic applications for medication management in ambulatory care (electronic prescribing, clinical decision support (CDSS), electronic health record, and computer generated paper prescriptions), while intended to reduce prescribing errors, can themselves result in errors that might harm patients or increase risks to patient safety.MethodsBecause a scoping search for adverse events in randomized controlled trials (RCTs) yielded few relevant results, we systematically searched nine databases, including MEDLINE, EMBASE, and The Cochrane Database of Systematic Reviews for systematic reviews and studies of a wide variety of designs that reported on implementation of the interventions. Studies that had safety and adverse events as outcomes, monitored for them, reported anecdotally adverse events or other events that might indicate a threat to patient safety were included.ResultsWe found no systematic reviews that examined adverse events or patient harm caused by organizational interventions. Of the 4056 titles and abstracts screened, 176 full-text articles were assessed for inclusion. Sixty-one studies with appropriate interventions, settings and participants but without patient safety, adverse event outcomes or monitoring for risks were excluded, along with 77 other non-eligible studies. Eighteen randomized controlled trials (RCTs), 5 non-randomized controlled trials (non-R,CTs) and 15 observational studies were included. The most common electronic intervention studied was CDSS and the most frequent clinical area was cardio-vascular, including anti-coagulants. No RCTS or non-R,CTS reported adverse event. Adverse events reported in observational studies occurred less frequently after implementation of CDSS. One RCT and one observational study reported an increase in problematic prescriptions with electronic prescribingConclusionsThe safety implications of electronic medication management in ambulatory care have not been established with results from studies included in this systematic review. Only a minority of studies that investigated these interventions included threats to patients' safety as outcomes or monitored for adverse events. It is therefore not surprising that we found little evidence to substantiate fears of new risks to patient safety with their implementation. More research is needed to focus on the draw-backs and negative outcomes that implementation of these interventions might introduce.

Project description:BackgroundThe health risks associated with poor medication practices in the home suggest that patients would benefit from home-based medication reviews that could detect and resolve these issues. However, remuneration for home visits often excludes ambulatory, nonhomebound patients. A subset of these patients have issues that cannot be adequately identified and resolved during the course of a typical pharmacy-based medication review.PurposeThis study aims to characterize the prevalence and nature of "hidden in the home" medication management issues in nonhomebound patients.MethodsPharmacists facilitated subject enrollment among patients at 6 community pharmacies in Toronto over a 15-month period, from January 2016 to March 2017. Patients taking 5 or more chronic medications who were ambulatory (able to visit the pharmacy) and scored 3 points or higher on a prescreening questionnaire were invited to participate. Visits included a standard medication review, the identification of drug therapy problems and an assessment of the patient's medication and organization/storage practices, followed by a medication cabinet cleanup.ResultsOne hundred patients were recruited, with a mean age of 76.9 years and taking on average 10 chronic medications. Pharmacists identified a total of 275 drug therapy problems (2.75 per patient). The most common issues reported additional therapy required (23.6%), nonadherence (23.3%) and adverse drug reactions (17.8%). For those patients 65 years or older (87%), 32% were found to be using at least 1 medication on the Beers Criteria list, while 6% were using 3 or more. Sulfonylureas, non-steroidal anti-inflammatory drugs and short-acting benzodiazepines were the most commonly implicated drugs. Medications were removed from the homes of 67% of the patients, with expiry of medication being the most common reason for removal (54.2%). The mean duration of a home visit was 49.5 minutes.ConclusionPharmacist-directed home medication reviews offer an effective mechanism to address the pharmacotherapy issues of patients taking multiple medications. These findings highlight the frequency of medication management issues in this group and suggest that home medication reviews could serve to minimize inappropriate use of medication and maximize health care cost savings in this unique patient population. Can Pharm J (Ott) 2019;152:xx-xx.

Dataset Information

The electronic medication complete communication (EMC²) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.

Background

Objective

Methods

Conclusions

Publications

The electronic medication complete communication (EMC<sup>2</sup>) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.

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OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

The electronic medication complete communication (EMC2) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.

Background

Objective

Methods

Conclusions

Publications

The electronic medication complete communication (EMC<sup>2</sup>) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

The electronic medication complete communication (EMC²) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.