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.

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.

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.

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.

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.

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.

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.