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An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial.

ABSTRACT: Currently, far too many older adults consume inappropriate prescriptions, which increase the risk of adverse drug reactions and unnecessary hospitalizations. A health education program directly informing patients of prescription risks may promote inappropriate prescription discontinuation in chronic benzodiazepine users.This is a cluster randomized controlled trial using a two-arm parallel-design. A total of 250 older chronic benzodiazepine users recruited from community pharmacies in the greater Montreal area will be studied with informed consent. A participating pharmacy with recruited participants represents a cluster, the unit of randomization. For every four pharmacies recruited, a simple 2:2 randomization is used to allocate clusters into intervention and control arms. Participants will be followed for 1 year. Within the intervention clusters, participants will receive a novel educational intervention detailing risks and safe alternatives to their current potentially inappropriate medication, while the control group will be wait-listed for the intervention for 6 months and receive usual care during that time period. The primary outcome is the rate of change in benzodiazepine use at 6 months. Secondary outcomes are changes in risk perception, self-efficacy for discontinuing benzodiazepines, and activation of patients initiating discussions with their physician or pharmacist about safer prescribing practices. An intention-to-treat analysis will be followed.The rate of change of benzodiazepine use will be compared between intervention and control groups at the individual level at the 6-month follow-up. Risk differences between the control and experimental groups will be calculated, and the robust variance estimator will be used to estimate the associated 95% confidence interval (CI). As a sensitivity analysis (and/or if any confounders are unbalanced between the groups), we will estimate the risk difference for the intervention via a marginal model estimated via generalized estimating equations with an exchangeable correlation structure.Targeting consumers directly as catalysts for engaging physicians and pharmacists in collaborative discontinuation of benzodiazepine drugs is a novel approach to reduce inappropriate prescriptions. By directly empowering chronic users with knowledge about risks, we hope to imitate the success of individually targeted anti-smoking campaigns.ClinicalTrials.gov identifier: NCT01148186.

SUBMITTER: Martin P

PROVIDER: S-EPMC3621099 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial.

Martin Philippe P Tamblyn Robyn R Ahmed Sara S Tannenbaum Cara C

Trials 20130320

<h4>Background</h4>Currently, far too many older adults consume inappropriate prescriptions, which increase the risk of adverse drug reactions and unnecessary hospitalizations. A health education program directly informing patients of prescription risks may promote inappropriate prescription discontinuation in chronic benzodiazepine users.<h4>Methods/design</h4>This is a cluster randomized controlled trial using a two-arm parallel-design. A total of 250 older chronic benzodiazepine users recruit ...[more]

PMID: 23514019

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Project description:BackgroundFor people living with dementia (PLWD) the overuse of potentially inappropriate medications (PIMs) remains a persistent problem. De-prescribing trials in the elderly have mixed results. Clinician champions may be uniquely suited to lead efforts to address this challenge. Here we describe the study protocol for a 24-month embedded pragmatic cluster-randomized clinical trial within two accountable care organizations (ACOs) of such a clinician champion intervention. The specific aims are to (1) assess the effectiveness of a clinician champion on de-implementing PIMs in PLWD, (2) determine if the intervention is associated with a reduction in emergency department (ED) visits and hospitalizations attributed to a fall, and (3) examine five implementation outcomes: appropriateness, feasibility, fidelity, penetration, and equity.Methods/designTwo ACOs agreed to participate: United States Medical Management (USMM) and Oschner Health System. The unit of randomization will be the primary care clinic. A clinician champion will be recruited from each of the intervention clinics to participate in a 6-month training program and then work with clinicians and staff in their clinic for 12 months to reduce the use of PIMs in their PLWD population. For aims 1 and 2, Medicare claims data will be used to assess outcomes. The outcome for aim #1 will be medication possession rates per quarter, for the three therapeutic classes of PIMs among patients with dementia in intervention clinics versus control clinics. For aim #2, we will assess the incidence of falls using a previously validated algorithm. For both aims 1 and 2, we will construct hierarchical models with time period observations nested within patient using generalized estimating equations (GEE) with robust standard errors. The key variable of interest will be the treatment indicator assigned based on practice. For aim #3, we will conduct qualitative thematic analysis of documentation by the clinician champions in their project workbooks to evaluate the five implementation outcomes.DiscussionThis embedded pragmatic trial will add to our existing knowledge regarding the effectiveness of a clinician champion strategy to de-prescribe potentially inappropriate medication among patients with dementia as well as its appropriateness, feasibility, fidelity, penetration, and equity.Trial registrationClinicaltrials.gov NCT05359679 , Registered May 4, 2022.

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:BackgroundPolypharmacy and the use of potentially inappropriate medications (PIMs) are prevalent among older patients admitted to hospitals, posing a heightened risk of adverse drug events. This trial aims to evaluate the effectiveness of a pharmacist-led deprescribing intervention in reducing medications, PIM and improving clinical outcomes, using the locally developed Malaysian Potentially Inappropriate Prescribing Screening tool in Older Adults (MALPIP).MethodsThis is an 18-month cluster-randomized, open-label, parallel-arm controlled trial conducted at 14 public hospitals in the Perak state of Malaysia. Patients aged 60 and above, who have at least one medication and one comorbidity are eligible. A stratified-cluster randomization design is employed, with 7 hospitals assigned to the control arm and 7 hospitals assigned to the intervention arm. The MALPIP screening tool will be used in the intervention group to review the medications. If PIM is detected, the pharmacists will discuss with doctors and decide whether to stop or reduce the dose. The primary outcomes of this trial are the total number of medications and number of PIM. The secondary outcomes include fall, emergency department visits, readmissions, quality of life and mortality. Outcomes will be measured during enrolment, discharge, 6, 12, and 18 months.DiscussionThis REVMED trial aims to test the hypothesis that a pharmacist-led deprescribing intervention initiated in the hospital will reduce the total number of medications and PIM 18 months after hospital discharge, reducing fall, emergency department visits, readmissions, mortality and lead to improvement in quality of life. Trial findings will quantify the clinical outcomes associated with reducing medications and PIM for hospitalized older adults with polypharmacy.Trial registration numberThis trial was prospectively registered at clinicaltrials.gov (NCT05875623) on the 25th of May 2023. NCT05875623 Clinicaltrials.gov URL: NCT05875623 registered on 25th July 2023.

Project description:BackgroundThe use of potentially inappropriate medications (PIMs) is common in older adults and is associated with potential negative consequences, such as falls and cognitive decline. Our objective was to investigate measurable patient factors associated with new outpatient prescribing of potentially inappropriate medications in older multimorbid adults already using multiple medications.MethodsIn this retrospective US cohort study, we used linked Medicare pharmacy and medical claims and electronic health record data from a large healthcare system in Massachusetts between 2007 and 2014. We identified patients aged ≥65 years with an office visit who had not been prescribed or used a PIM in the prior 180 days. PIMs were defined using 2019 Beers criteria of the American Geriatrics Society. To specifically evaluate factors in patients with polypharmacy and multimorbidity, we selected those who filled medications for ≥90 days (i.e., chronic use) from ≥5 pharmaceutical classes in the prior 180 days and had ≥2 chronic conditions. Multivariable Cox regression analysis was used to estimate the association between baseline demographic and clinical characteristics on the probability of being prescribed a PIM in the 90-day follow-up period.ResultsIn total, we identified 17,912 patients aged ≥65 years with multimorbidity and polypharmacy who were naïve to a PIM in the prior 180 days. Of those, 10,497 (58.6%) were female, and mean age was 78 (SD = 7.5). On average, patients had 5.1 (SD = 2.3) chronic conditions and previously filled 6.1 (SD = 1.4) chronic medications. In total, 447 patients (2.5%) were prescribed a PIM during the 90-day follow-up. Male sex (adjusted hazard ratio (HR) = 1.29; 95%CI: 1.06-1.57), age (≥85 years: HR = 0.75, 95%CI: 0.56-0.99, 75-84 years: HR = 0.87, 95%CI: 0.71-1.07; reference: 65-74 years), ambulatory visits (18-29 visits: HR = 1.42, 95%CI: 1.06-1.92; ≥30 visits: HR = 2.12, 95%CI: 1.53-2.95; reference: ≤9 visits), number of prescribing orders (HR = 1.02, 95%CI: 1.01-1.02 per 1-unit increase), and heart failure (HR = 1.38, 95%CI: 1.07-1.78) were independently associated with being newly prescribed a PIM.ConclusionSeveral demographic and clinical characteristics, including factors suggesting lack of care coordination and increased clinical complexity, were found to be associated with the new prescribing of potentially inappropriate medications. This knowledge could inform the design of interventions and policies to optimize pharmacotherapy for these patients.

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An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial.

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An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial.

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