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A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial.

ABSTRACT: BACKGROUND:Polypharmacy is prevalent among hospitalized older adults, particularly those being discharged to a post-care care facility (PAC). The aim of this randomized controlled trial is to determine if a patient-centered deprescribing intervention initiated in the hospital and continued in the PAC setting reduces the total number of medications among older patients. METHODS:The Shed-MEDS study is a 5-year, randomized controlled clinical intervention trial comparing a patient-centered describing intervention with usual care among older (?50?years) hospitalized patients discharged to PAC, either a skilled nursing facility (SNF) or an inpatient rehabilitation facility (IPR). Patient measurements occur at hospital enrollment, hospital discharge, within 7?days of PAC discharge, and at 60 and 90?days following PAC discharge. Patients are randomized in a permuted block fashion, with block sizes of two to four. The overall effectiveness of the intervention will be evaluated using total medication count as the primary outcome measure. We estimate that 576 patients will enroll in the study. Following attrition due to death or loss to follow-up, 420 patients will contribute measurements at 90?days, which provides 90% power to detect a 30% versus 25% reduction in total medications with an alpha error of 0.05. Secondary outcomes include the number of medications associated with geriatric syndromes, drug burden index, medication adherence, the prevalence and severity of geriatric syndromes and functional health status. DISCUSSION:The Shed-MEDS trial aims to test the hypothesis that a patient-centered deprescribing intervention initiated in the hospital and continuing through the PAC stay will reduce the total number of medications 90?days following PAC discharge and result in improvements in geriatric syndromes and functional health status. The results of this trial will quantify the health outcomes associated with reducing medications for hospitalized older adults with polypharmacy who are discharged to post-acute care facilities. TRIAL REGISTRATION:This trial was prospectively registered at clinicaltrials.gov ( NCT02979353 ). The trial was first registered on 12/1/2016, with an update on 09/28/17 and 10/12/2018.

SUBMITTER: Vasilevskis EE

PROVIDER: S-EPMC6416929 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial.

Vasilevskis Eduard E EE Shah Avantika S AS Hollingsworth Emily K EK Shotwell Matthew S MS Mixon Amanda S AS Bell Susan P SP Kripalani Sunil S Schnelle John F JF Simmons Sandra F SF

BMC health services research 20190314 1

<h4>Background</h4>Polypharmacy is prevalent among hospitalized older adults, particularly those being discharged to a post-care care facility (PAC). The aim of this randomized controlled trial is to determine if a patient-centered deprescribing intervention initiated in the hospital and continued in the PAC setting reduces the total number of medications among older patients.<h4>Methods</h4>The Shed-MEDS study is a 5-year, randomized controlled clinical intervention trial comparing a patient-ce ...[more]

PMID: 30871561

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Project description:Background:Polypharmacy is common in hospitalized older adults. Deprescribing interventions are not well described in the acute-care setting. The objective of this study was to describe a hospital-based, patient-centered deprescribing protocol (Shed-MEDS) and report pilot results. Methods:This was a pilot study set in one academic medical center in the United States. Participants consisted of a convenience sample of 40 Medicare-eligible, hospitalized patients with at least five prescribed medications. A deprescribing protocol (Shed-MEDS) was implemented among 20 intervention and 20 usual care control patients during their hospital stay. The primary outcome was the total number of medications deprescribed from hospital enrollment. Deprescribed was defined as medication termination or dose reduction. Enrollment medications reflected all prehospital medications and active in-hospital medications. Baseline characteristics and outcomes were compared between the intervention and usual care groups using simple logistic or linear regression for categorical and continuous measures, respectively. Results:There was no significant difference between groups in mean age, sex or Charlson comorbidity index. The intervention and control groups had a comparable number of medications at enrollment, 25.2 (±6.3) and 23.4 (±3.8), respectively. The number of prehospital medications in each group was 13.3 (±4.6) and 15.3 (±4.6), respectively. The Shed-MEDS protocol compared with usual care significantly increased the mean number of deprescribed medications at hospital discharge and reduced the total medication burden by 11.6 versus 9.1 (p = 0.032) medications. The deprescribing intervention was associated with a difference of 4.6 [95% confidence interval (CI) 2.5-6.7, p < 0.001] in deprescribed medications and a 0.5 point reduction (95% CI -0.01 to 1.1) in the drug burden index. Conclusions:A hospital-based, patient-centered deprescribing intervention is feasible and may reduce the medication burden in older adults.

Project description:Background and objectivesEffective deprescribing requires shared decision making between a patient and their clinician, and should be used when implementing evidence-based deprescribing conversations. As part of the Shed-MEDS clinical trial, this study assessed barriers and enablers that influence patient decision making in deprescribing to inform future implementation efforts and adaptations.Research design and methodsShed-MEDS, a randomized controlled deprescribing trial, included hospitalized older adults discharging to post-acute care facilities. A trained clinician reviewed each participant's medical history and medication list to identify medications with potential for deprescribing. The study clinician then conducted a semistructured patient-centered deprescribing interview to determine patient (or surrogate) concerns about medications and willingness to deprescribe. Reeve et al.'s (2013) framework was used to categorize barriers and enablers to deprescribing from the patient's perspective, including "appropriateness of cessation," "fear," "dislike of a medication," "influences," and "process of cessation."ResultsOverall, participants/surrogates (N = 177) agreed with 63% (883 total medications) of the study clinician's deprescribing recommendations. Thematic analysis revealed that "appropriateness" of a medication was the most common barrier (88.2%) and enabler (67.3%) to deprescribing. Other deprescribing enablers were in the following domains: "influences" (22.7%), "process" (22.5%), "pragmatic" (19.4%), and "dislike" (5.3%).Discussion and implicationsUse of a semistructured deprescribing interview conversation tool allowed study clinicians to elicit individual barriers and enablers to deprescribing from the patient's perspective. Participants in this study expressed more agreement than disagreement with study clinicians' deprescribing recommendations. These results should inform future implementation efforts that incorporate a patient-centered framework during deprescribing conversations.Clinical trials registration numberNCT02979353.

Project description:BackgroundPolypharmacy is an increasing problem, leading to increased morbidity and mortality, especially in older, multimorbid patients. Consequently, there is a need for reduction of polypharmacy. The aim of this study was to explore attitudes, beliefs, and concerns towards deprescribing among older, multimorbid patients with polypharmacy who chose not to pursue at least one of their GP's offers to deprescribe.MethodsExploratory study using telephone interviews among patients of a cluster-randomized study in Northern Switzerland. The interview included a qualitative part consisting of questions in five pre-defined key areas of attitudes, beliefs, and concerns about deprescribing and an open explorative question. The quantitative part consisted of a rating of pre-defined statements in these areas.ResultsTwenty-two of 87 older, multimorbid patients with polypharmacy, to whom their GP offered a drug change, did not pursue all offers. Nineteen of these 22 were interviewed by telephone. The 19 patients were on average 76.9 (SD 10.0) years old, 74% female, and took 8.9 (SD 2.6) drugs per day. Drugs for acid-related disorders, analgesics and anti-inflammatory drugs were the three most common drug groups where patient involvement and the shared-decision-making (SDM) process led to the joint decision to not pursue the GPs offer. Eighteen of 19 patients fully trusted their GP, 17 of 19 participated in SDM even before this study and 8 of 19 perceived polypharmacy as a substantial burden. Conservatism/inertia and fragmented medical care were the main barriers towards deprescribing. No patient felt devalued as a consequence of the deprescribing offer. Our exploratory findings were supported by patients' ratings of predefined statements.ConclusionWe identified patient involvement in deprescribing and coordination of care as key issues for deprescribing among older multimorbid patients with polypharmacy. GPs concerns regarding patients' devaluation should not prevent them from actively discussing the reduction of drugs.Trial registrationISRCTN16560559 .

Project description:BackgroundPolypharmacy, and the associated adverse drug events such as non-adherence to prescriptions, is a common problem for elderly people living with multiple comorbidities. Deprescribing, i.e. the gradual withdrawal from medications with supervision by a healthcare professional, is regarded as a means of reducing adverse effects of multiple medications including non-adherence. This systematic review examines the evidence of deprescribing as an effective strategy for improving medication adherence amongst older, community dwelling adults.MethodsA mixed methods review was undertaken. Eight bibliographic database and two clinical trials registers were searched between May and December 2017. Results were double screened in accordance with pre-defined inclusion/exclusion criteria related to polypharmacy, deprescribing and adherence in older, community dwelling populations. The Mixed Methods Appraisal Tool (MMAT) was used for quality appraisal and an a priori data collection instrument was used. For the quantitative studies, a narrative synthesis approach was taken. The qualitative data was analysed using framework analysis. Findings were integrated using a mixed methods technique. The review was performed in accordance with the PRISMA reporting statement.ResultsA total of 22 original studies were included, of which 12 were RCTs. Deprescribing with adherence as an outcome measure was identified in randomised controlled trials (RCTs), observational and cohort studies from 13 countries between 1996 and 2017. There were 17 pharmacy-led interventions; others were led by General Practitioners (GP) and nurses. Four studies demonstrated an overall reduction in medications of which all studies corresponded with improved adherence. A total of thirteen studies reported improved adherence of which 5 were RCTs. Adherence was reported as a secondary outcome in all but one study.ConclusionsThere is insufficient evidence to show that deprescribing improves medication adherence. Only 13 studies (of 22) reported adherence of which only 5 were randomised controlled trials. Older people are particularly susceptible to non-adherence due to multi-morbidity associated with polypharmacy. Bio-psycho-social factors including health literacy and multi-disciplinary team interventions influence adherence. The authors recommend further study into the efficacy and outcomes of medicines management interventions. A consensus on priority outcome measurements for prescribed medications is indicated.Trial registrationPROSPERO number CRD42017075315.

Project description:We describe the study design and methods used in a 9-month pedometer-based worksite intervention called "ASUKI Step" conducted at the Karolinska Institutet (KI) in Stockholm, Sweden and Arizona State University (ASU) in the greater Phoenix area, Arizona."ASUKI Step" was based on the theory of social support and a quasi-experimental design was used for evaluation. Participants included 2,118 faculty, staff, and graduate students from ASU (n = 712) and KI (n = 1,406) who participated in teams of 3-4 persons. The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week. Study aims were: 1) to have a minimum of 400 employee participants from each university site reach a level of 10,000 steps per day on at least 100 days (3.5 months) during the trial period; 2) to have 70% of the employee participants from each university site maintain two or fewer inactive days per week, defined as a level of less than 3,000 steps per day; 3) to describe the socio-demographic, psychosocial, environmental and health-related determinants of success in the intervention; and 4) to evaluate the effects of a pedometer-based walking intervention in a university setting on changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness.Incentives were given for compliance to the study protocol that included weekly raffles for participation prizes and a grand finale trip to Arizona or Sweden for teams with most days over 10,000 steps."ASUKI Step" is designed to increase the number of days employees walk 10,000 steps and to reduce the number of days employees spend being inactive. The study also evaluates the intra- and interpersonal determinants for success in the intervention and in a sub-sample of the study, changes in physical fitness and body composition during the study.Current Controlled Trials NCT01537939.

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A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial.

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A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial.

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