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

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.

Health literacy, cognition, and urinary incontinence among geriatric inpatients discharged to skilled nursing facilities.

AIMS: To investigate the association between health literacy and cognition and nursing and patient-reported incontinence in a geriatric inpatient population transitioning to skilled nursing facilities (SNF). METHODS: Health literacy, depression, and cognition were assessed via the Brief Health Literacy Screen (BHLS), Geriatric Depression Scale 5-item (GDS) and Brief Interview for Mental Status (BIMS), respectively. Multivariable logistic regression assessed the association between BHLS score and incontinence by: (1) nursing-reported urinary incontinence during hospitalization; and (2) patient self-reported "bladder accidents" in the post-enrollment study interview. RESULTS: A total of 1556 hospitalized patients aged 65 and older met inclusion criteria, of whom 922 (59.3%) were women and 1480 had available BHLS scores. A total of 464 (29.8%) and 515 (33.1%) patients had nursing-reported and self-reported urinary incontinence, respectively. Nursing-reported incontinence was significantly associated with lower BHLS (ie, poorer health literacy) (aOR 0.93, 95%CI 0.89-0.99) and BIMS (ie, poorer cognition) (aOR 0.90, 95%CI 0.83-0.97) scores and need for assistance with toileting (aOR 7.08, 95%CI 2.16-23.21). Patient-reported incontinence was significantly associated with female sex (aOR 1.62, 95%CI 1.19-2.21), increased GDS score (ie, greater likelihood of depression) (aOR 1.22, 95%CI 1.10-1.36) and need for assistance with toileting (aOR 2.46, 95%CI 1.26-4.79). CONCLUSIONS: Poorer health literacy and cognition are independently associated with an increased likelihood of nursing-reported urinary incontinence among geriatric inpatients transitioning to SNF. Practitioners should consider assessment of health literacy and cognition in frail patients at risk for urinary incontinence and that patient and nursing assessment may be required to capture the diagnosis.

Medication Discrepancies among Older Hospitalized Adults Discharged from Post-Acute Care Facilities to Home.

OBJECTIVES: The epidemiology of medication discrepancies during transitions from post-acute care (PAC) to home is poorly described. We sought to describe the frequency and types of medication discrepancies among hospitalized older adults transitioning from PAC to home. DESIGN: A nested cohort analysis. SETTING AND PARTICIPANTS: Included participants enrolled in a patient-centered deprescribing trial, for patients (aged ≥50 years and taking at least 5 medications) transitioning from one of 22 PACs to home. METHODS: We assessed demographic and medication measures at the initial hospitalization. The primary outcome measure was medication discrepancies, with the PAC discharge list serving as reference for comparison to the participant's self-reported medication list at 7 days following PAC discharge. Discrepancies were categorized as additions, omissions, and dose discrepancies and were organized by common medication classes and risk of harm (eg, 2015 Beers Criteria). Ordinal logistic regression assessed for patient risk factors for PAC discharge discrepancy count. RESULTS: A total of 184 participants had 7-day PAC discharge medication data. Participants were predominately female (67%) and Caucasian (83%) with a median of 16 prehospital medications [interquartile range (IQR) 11, 20]. At the 7-day follow-up, 98% of participants had at least 1 medication discrepancy, with a median number of 7 medication discrepancies (IQR 4, 10) per person, 4 (IQR 2, 6) of which were potentially inappropriate medications as defined by the Beers Criteria. Higher medication discrepancies at index hospital admission and receipt of caregiver assistance with medications were 2 key predictors of medication discrepancies in the week after PAC discharge to home. CONCLUSIONS AND IMPLICATIONS: Older patients transitioning home from a PAC facility are at high risk for medication discrepancies. This study underscores the need for interventions targeted at this overlooked transition period, especially as patients resume responsibility for managing their own medications after both a hospital and PAC stay.

Emergency department visits and hospital readmissions after a deprescribing intervention among hospitalized older adults.

BACKGROUND: Deprescribing is the planned/supervised method of dose reduction or cessation of medications that might be harmful, or no longer be beneficial. Though benefits of deprescribing are debatable in improving clinical outcomes, it has been associated with decreased number of potentially inappropriate medications, which may potentially reduce the risk of adverse events among hospitalized older adults. With unclear evidence for deprescribing in this population, this study aimed to examine time-to-first unplanned healthcare utilization, which included 90-day emergency department (ED) visits or hospital readmission and associated predictors, during a deprescribing intervention. METHODS: A secondary data analysis of a clinical trial (Shed-MEDS NCT02979353) was performed. Cox regression was used to compare the time-to-first 90-day ED visit/readmission/death from hospital discharge for the intervention and control groups. Additionally, we performed exploratory analysis of predictors (comorbidities, functional health status, drug burden index (DBI), hospital length of stay, health literacy, food insecurity, and financial burden) associated with the time-to-first 90-day ED visit/readmission/death. RESULTS: The hazard of first 90-day ED visits/readmissions/death was 15% lower in the intervention versus the control group (95% CI: 0.61-1.19, p = 0.352, respectively); however, this difference was not statistically significant. For every additional number of comorbidities (Hazard ratio (HR): 1.12, 95% CI: 1.04-1.21) and each additional day of hospital length of stay (HR: 1.04, 95% CI: 1.01-1.07) were significantly associated with a higher hazard of 90-day ED visit/readmission/death in the intervention group; whereas for each unit of increase in pre-hospital DBI score (HR: 1.08 and HR 1.16, respectively) was significantly associated with a higher hazard of 90-day ED visit/readmission/death in the control group. CONCLUSIONS: The intervention and control groups had comparable time-to-first 90-day ED visit/readmission/death during a deprescribing intervention. This finding suggests that deprescribing did not result in a higher risk of ED visit/readmission/death during the 90-day period following hospital discharge.

Why do Older Adults Decline Participation in Research? Results from Two Deprescribing Clinical Trials.

Background Heterogenous older adult populations are underrepresented in clinical trials, and their participation is necessary for interventions that directly target them. The purpose of this study was to evaluate reasons why hospitalized older adults declined participation in two deprescribing clinical trials. Methods We report enrollment data from two deprescribing trials, Shed-MEDS (non-Veterans) and VA DROP (Veterans). For both trials, inclusion criteria required participants to be hospitalized, age 50 or older, English-speaking, and taking five or more home medications. Eligible patients were approached for enrollment while hospitalized. When an eligible patient or surrogate declined participation, the reason(s) were recorded and subsequently analyzed inductively to develop themes, and a Chi-square test was used for comparison. Results Across both trials, 1226 patients (545 non-Veterans and 681 Veterans) declined enrollment and provided reasons, which were condensed into three themes: (1) feeling overwhelmed by their current health status, (2) lack of interest or mistrust of research, and (3) hesitancy to participate in a deprescribing study. A greater proportion of Veterans expressed a lack of interest or mistrust in research (42% vs 26%, chi-square value = 36.72, p < .001); whereas a greater proportion of non-Veterans expressed feeling overwhelmed by their current health status (54% vs 35%, chi-square value = 42.8 p < 0.001). Across both trials, similar proportion of patients expressed hesitancy to participate in a deprescribing study, with no significant difference between Veterans and non-Veterans (23% and 21%). Conclusions The inclusion of older adults in clinical trial research broadens its impact. Understanding the reasons older adults decline participation can inform future strategies to engage this multimorbid population.

Why do older adults decline participation in research? Results from two deprescribing clinical trials.

BACKGROUND: Heterogenous older adult populations are underrepresented in clinical trials, and their participation is necessary for interventions that directly target them. The purpose of this study was to evaluate reasons why hospitalized older adults declined participation in two deprescribing clinical trials. METHODS: We report enrollment data from two deprescribing trials, Shed-MEDS (non-Veterans) and VA DROP (Veterans). For both trials, inclusion criteria required participants to be hospitalized, age 50 or older, English-speaking, and taking five or more home medications. Eligible patients were approached for enrollment while hospitalized. When an eligible patient or surrogate declined participation, the reason(s) were recorded and subsequently analyzed inductively to develop themes, and a chi-square test was used for comparison (of themes between Veterans and non-Veterans). RESULTS: Across both trials, 1226 patients (545 non-Veterans and 681 Veterans) declined enrollment and provided reasons, which were condensed into three themes: (1) feeling overwhelmed by their current health status, (2) lack of interest or mistrust of research, and (3) hesitancy to participate in a deprescribing study. A greater proportion of Veterans expressed a lack of interest or mistrust in research (42% vs 26%, chi-square value = 36.72, p < .001), whereas a greater proportion of non-Veterans expressed feeling overwhelmed by their current health status (54% vs 35%, chi-square value = 42.8 p < 0.001). Across both trials, similar proportion of patients expressed hesitancy to participate in a deprescribing study, with no significant difference between Veterans and non-Veterans (23% and 21%). CONCLUSIONS: Understanding the reasons older adults decline participation can inform future strategies to engage this multimorbid population.

Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial.

Importance: Deprescribing is a promising approach to addressing the burden of polypharmacy. Few studies have initiated comprehensive deprescribing in the hospital setting among older patients requiring ongoing care in a postacute care (PAC) facility. Objective: To evaluate the efficacy of a patient-centered deprescribing intervention among hospitalized older adults transitioning or being discharged to a PAC facility. Design, Setting, and Participants: This randomized clinical trial of the Shed-MEDS (Best Possible Medication History, Evaluate, Deprescribing Recommendations, and Synthesis) deprescribing intervention was conducted between March 2016 and October 2020. Patients who were admitted to an academic medical center and discharged to 1 of 22 PAC facilities affiliated with the medical center were recruited. Patients who were 50 years or older and had 5 or more prehospital medications were enrolled and randomized 1:1 to the intervention group or control group. Patients who were non-English speaking, were unhoused, were long-stay residents of nursing homes, or had less than 6 months of life expectancy were excluded. An intention-to-treat approach was used. Interventions: The intervention group received the Shed-MEDS intervention, which consisted of a pharmacist- or nurse practitioner-led comprehensive medication review, patient or surrogate-approved deprescribing recommendations, and deprescribing actions that were initiated in the hospital and continued throughout the PAC facility stay. The control group received usual care at the hospital and PAC facility. Main Outcomes and Measures: The primary outcome was the total medication count at hospital discharge and PAC facility discharge, with follow-up assessments during the 90-day period after PAC facility discharge. Secondary outcomes included the total number of potentially inappropriate medications at each time point, the Drug Burden Index, and adverse events. Results: A total of 372 participants (mean [SD] age, 76.2 [10.7] years; 229 females [62%]) were randomized to the intervention or control groups. Of these participants, 284 were included in the intention-to-treat analysis (142 in the intervention group and 142 in the control group). Overall, there was a statistically significant treatment effect, with patients in the intervention group taking a mean of 14% fewer medications at PAC facility discharge (mean ratio, 0.86; 95% CI, 0.80-0.93; P < .001) and 15% fewer medications at the 90-day follow-up (mean ratio, 0.85; 95% CI, 0.78-0.92; P < .001) compared with the control group. The intervention additionally reduced patient exposure to potentially inappropriate medications and Drug Burden Index. Adverse drug event rates were similar between the intervention and control groups (hazard ratio, 0.83; 95% CI, 0.52-1.30). Conclusions and Relevance: Results of this trial showed that the Shed-MEDS patient-centered deprescribing intervention was safe and effective in reducing the total medication burden at PAC facility discharge and 90 days after discharge. Future studies are needed to examine the effect of this intervention on patient-reported and long-term clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02979353.

Patient-Reported Barriers and Enablers to Deprescribing Recommendations During a Clinical Trial (Shed-MEDS).

BACKGROUND AND OBJECTIVES: Effective 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 METHODS: Shed-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." RESULTS: Overall, 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 IMPLICATIONS: Use 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 NUMBER: NCT02979353.

Older Patient and Surrogate Attitudes Toward Deprescribing During the Transition From Acute to Post-Acute Care.

Attitudes toward deprescribing among hospitalized older patients transitioning to post-acute care in the United States are less known. This study describes older patients' and their surrogate's attitudes using all items of the Patient Attitudes Toward Deprescribing (PATD) questionnaire and compares perceived pill burden to the actual count of total daily pills and potentially inappropriate medications (PIMs). Overall, 93% of participants were willing to deprescribe if their physician agreed. Compared to patients, surrogates had 64% reduced odds (95% CI: 0.18-0.74) of believing that all of the care recipient's medications were necessary and 61% reduced odds (95% CI: 0.17-0.88) of attributing cost as a factor in deprescribing. Perceptions of medication burden were associated with patients' total daily pills (median 16) and PIMS (median 7), yet 61% agreed that all their medicines were necessary. Patients and surrogates typically express a willingness to deprescribe but have differing perceptions of medication appropriateness.

Sources of medication omissions among hospitalized older adults with polypharmacy.

BACKGROUND: Hospitalized older adults have a high prevalence of polypharmacy and medication inaccuracies. Gathering the best possible medication history (BPMH) is necessary to accurately identify each medication for multimorbid older adults. The objective was to describe a multipronged approach to obtaining the BPMH for hospitalized older adults, quantify the medication discrepancies identified through these sources, and explore factors associated with these discrepancies. METHODS: Cross-sectional analysis of 372 hospitalized older adults (age ≥ 50) transitioning to post-acute care as part of a randomized controlled trial to reduce medication burden. We used four information sources to yield a BPMH. Medication discrepancies at hospital admission were categorized as omissions, additions, and dose discrepancies after comparing alternate sources with the electronic medical record (EMR). Multivariate regression analysis, including patient factors (e.g., age, prehospital medication count, number of pharmacies), was performed to identify factors associated with the total count of medication discrepancies. RESULTS: Ninety percent of participants had at least one medication discrepancy and 46% used more than one pharmacy. The majority of discrepancies were omissions. Among the entire cohort, there was a median of two omitted medications per patient across two alternate sources-pharmacy refill history and bedside interview. Lower age, greater total number of prehospital medications, and admission from assisted living or skilled nursing facility were significantly associated with greater medication discrepancies. CONCLUSION: A multipronged and consistent approach to obtain a BPMH during hospitalization for multimorbid older adults revealed medication discrepancies that should be addressed prior to hospital discharge to support safe prescribing practices.

Medications Associated With Geriatric Syndromes (MAGS) and Hospitalization Risk in Home Health Care Patients.

OBJECTIVES: Polypharmacy is common in home health care (HHC). This study examined the prevalence of medications associated with geriatric syndromes (MAGS), its predictors, and association with subsequent hospitalization in HHC. DESIGN: Analysis of HHC electronic medical records, the Outcome and Assessment Information Set (OASIS), and Medicare HHC claims. SETTING AND PARTICIPANTS: A total of 6882 adults ≥65 years old receiving HHC in 2019 from a large, not-for-profit home health agency serving multiple counties in New York State. MEASURES: MAGS use was identified from active medications reconciled during HHC visits (HHC electronic medical records). MAGS use was operationalized as count and in quartiles. Hospitalization during the HHC episode was operationalized as a time-to-event variable (ie, number of days from HHC admission to hospitalization). We used regression analyses to identify predictors of MAGS use, and survival analyses to examine the association between MAGS and hospitalization. RESULTS: Nearly all (98%) of the HHC patients used at least 1 MAGS and 41% of all active medications used by the sample were MAGS. More MAGS use was found in HHC patients who were community-referred, taking more medications, and having more diagnoses, depressive symptoms, and functional limitations. Adjusted for covariates, higher MAGS quartiles were not independently associated with the risk of hospitalization, but higher MAGS quartiles combined with multimorbidity (ie, having ≥10 diagnoses) were associated with a 2.3-fold increase in hospitalization risk (hazard ratio 2.24; 95% confidence interval: 1.61-3.13; P < .001), relative to the lowest quartile of MAGS use and having <10 diagnoses. CONCLUSIONS AND IMPLICATIONS: More than 40% of medications taken by HHC patients are MAGS. Multimorbidity and MAGS use collectively increased the risk of hospitalization by up to 2.3 times. HHC clinicians should carefully review patients' medications and use information about MAGS to facilitate discussion about deprescribing with patients and their prescribers.

Frailty Is Related to Subjective Cognitive Decline in Older Women without Dementia.

OBJECTIVES: Physical frailty (or loss of physiologic reserve) is associated with cognitive impairment and dementia. Subjective cognitive decline (SCD) may represent early pathologic changes of dementia. The association between these disease markers is unclear. DESIGN: Cross-sectional analysis. SETTING: Community-based participants from the Vanderbilt Memory & Aging Project. PARTICIPANTS: A total of 306 older adults with normal cognition (NC; n = 174) or mild cognitive impairment (MCI; n = 132). MEASUREMENTS: Frailty was measured using standard methods, and a composite frailty score was calculated. SCD was quantified using the Everyday Cognition Scale (ECog; total score and four domain scores). Objective cognition was assessed with the Montreal Cognitive Assessment (MoCA). Proportional odds models, stratified by sex, related the frailty composite to MoCA and total ECog score adjusting for age, education, body mass index, cognitive diagnosis, depressed mood, Framingham Stroke Risk Profile, apolipoprotein E (APOE ε4) carrier status, and height (for gait speed models). Secondary models related individual frailty components to SCD domains and explored associations in NC only. RESULTS: In women, frailty composite was related to MoCA (odds ratio [OR] = .56; P = .04), a finding attenuated in sensitivity analysis (OR = .59; P = .08). Frailty composite related to ECog total (OR = 2.27; P = .02), planning (OR = 2.63; P = .02), and organization scores (OR = 2.39; P = .03). Increasing gait speed related to lower ECog total (OR = .06; P = .003) and memory scores (OR = .03; P < .001). Grip strength related to lower ECog planning score (OR = .91; P = .04). In men, frailty was unrelated to objective and subjective cognition (P values >.07). Findings were consistent in the NC group. CONCLUSION: Frailty component and composite scores are related to SCD before the presence of overt dementia. Results suggest that this association is present before overt cognitive impairment. Results suggest a possible sex difference in the clinical manifestation of frailty, with primary associations noted in women. Further studies should investigate mechanisms linking early changes among frailty, SCD, and cognition. J Am Geriatr Soc, 1-9, 2019. J Am Geriatr Soc 67:1803-1811, 2019.

Managing Person-Centered Dementia Care in an Assisted Living Facility: Staffing and Time Considerations.

Background and Objectives: To describe (a) the unlicensed staff time necessary to provide quality activities of daily living (ADL) care to residents receiving dementia care within an assisted living facility and (b) a staff management approach to maintain quality ADL care. Research Design and Methods: Supervisory staff used a standardized observational method to measure ADL care quality and the staff time to provide care during the morning and evening across 12 consecutive months. Staff were given individual feedback about the quality of their care provision following each observation. Results: The average staff time to provide ADL care averaged 35 (± 11) minutes per resident per care episode with bathing and 18 (± 6) minutes/resident/care episode without bathing. Morning ADL care required significantly more staff time than evening care. There was not a significant relationship between residents' levels of cognitive impairment or ADL dependency and the staff time to provide ADL care. Quality ADL care was maintained for 12 months. Discussion and Implications: This study provides novel data related to the amount of staff time necessary to provide quality ADL care for persons with dementia in an assisted living care setting. This study also describes a standardized approach to staff management that was effective in maintaining quality ADL care provision. Assisted living facilities should consider these data when determining the necessary unlicensed staffing level to provide person-centered ADL care and how to effectively manage direct care providers.

Shed-MEDS: pilot of a patient-centered deprescribing framework reduces medications in hospitalized older adults being transferred to inpatient postacute care.

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.