Browsing by Author "Fowler, Nicole"
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Item Adherence and Tolerability of Alzheimer's Disease Medications: A Pragmatic Randomized Trial(Wiley, 2017-07) Campbell, Noll L.; Perkins, Anthony J.; Gao, Sujuan; Skaar, Todd C.; Li, Lang; Hendrie, Hugh C.; Fowler, Nicole; Callahan, Christopher M.; Boustani, Malaz A.; Department of Medicine, IU School of MedicineBACKGROUND/OBJECTIVES: Post-marketing comparative trials describe medication use patterns in diverse, real-world populations. Our objective was to determine if differences in rates of adherence and tolerability exist among new users to acetylcholinesterase inhibitors (AChEI's). DESIGN: Pragmatic randomized, open label comparative trial of AChEI's currently available in the United States. SETTING: Four memory care practices within four healthcare systems in the greater Indianapolis area. PARTICIPANTS: Eligibility criteria included older adults with a diagnosis of possible or probable Alzheimer's disease (AD) who were initiating treatment with an AChEI. Participants were required to have a caregiver to complete assessments, access to a telephone, and be able to understand English. Exclusion criteria consisted of a prior severe adverse event from AChEIs. INTERVENTION: Participants were randomized to one of three AChEIs in a 1:1:1 ratio and followed for 18 weeks. MEASUREMENTS: Caregiver-reported adherence, defined as taking or not taking study medication, and caregiver-reported adverse events, defined as the presence of an adverse event. RESULTS: 196 participants were included with 74.0% female, 30.6% African Americans, and 72.9% who completed at least twelfth grade. Discontinuation rates after 18 weeks were 38.8% for donepezil, 53.0% for galantamine, and 58.7% for rivastigmine (P = .063) in the intent to treat analysis. Adverse events and cost explained 73.1% and 25.4% of discontinuation. No participants discontinued donepezil due to cost. Adverse events were reported by 81.2% of all participants; no between-group differences in total adverse events were statistically significant. CONCLUSIONS: This pragmatic comparative trial showed high rates of adverse events and cost-related non-adherence with AChEIs. Interventions improving adherence and persistence to AChEIs may improve AD management. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01362686 (https://clinicaltrials.gov/ct2/show/NCT01362686).Item Association Between Quality of Life and Depression in Dyads of Older Primary Care Patients and Family Members(Oxford University Press, 2022-12-20) Fowler, Nicole; Perkins, Anthony; Park, Seho; Schroeder, Matthew; Boustani, Malaz; School of NursingFamilial dyads experience illness as an interdependent unit. We evaluate the association of quality of life (QOL), as measured by physical (PCS) and mental health component (MCS) scores, with depression in dyads of older primary care patients and a family member. This is a cross sectional, descriptive study where QOL and depression were measured concurrently in the dyad using baseline data from 1809 dyads enrolled in a trial testing the benefits and harms of Alzheimer’s disease and related dementias (ADRD) screening. QOL was measured with the SF-36, depression was measured with the PHQ-9, and the association of depression with QOL was examined using an actor-partner interdependence model with distinguishable dyads. Patient mean (SD) age was 73.7 (5.7) years; 53.1% women; 85.1% white; 13.4% black. Family member mean (SD) age was 64.2 (13) years; 67.7% women; 13.4% black. A patient’s spouse/partner were 64.8% of family members. After controlling for dyadic relationship and gender, significant actor effects of depression on PCS for patient (β= -1.39; p< 0.001) and family member (β =-0.954; p< 0.001), and significant partner effects of depression on PCS for patient (β=-0.15, p< 0.05) and family member (β =-0.18; p< 0.01). There were significant actor effects of depression on MCS for patient (β =-1.2; p< 0.001) and family member (β=-1.2; p< 0.001), but depression had a significant partner effect on MCS only for patient (β = -0.08; p< 0.05). Among dyads participating in an ADRD screening trial, dyads with higher depression had lower QOL. Family member depression was associated with decreased family member and patient QOL.Item Association Between Subjective Cognitive Decline and Strength Training in US Adults Aged 45+ Years(Oxford University Press, 2022-12-20) Schroeder, Matthew; Waring, Molly; Fowler, Nicole; Pagoto, Sherry; Medicine, School of MedicineSubjective cognitive decline (SCD) can be an early marker for Alzheimer’s disease and related dementias. Data supports physical activity to delay cognitive impairment and to improve cognitive functioning. We examined strength training engagement by middle-aged and older US adults with and without SCD. We used data from 121, 059 participated aged 45 years or older from the 2019 Behavioral Risk Factor Surveillance System (BRFSS) from 31 states and Washington, D.C. SCD was assessed by asking participants if they had experienced confusion or memory loss during the past 12 months (yes/no). Participants reported how often they engaged in strength training (e.g., using weight machine, free weights) in the past month. We dichotomized strength training engagement as meeting physical activity recommendations (2+ times weekly) or not (< 2 times weekly). An adjusted logistic regression model, controlling for confounding variables, estimated the likelihood of strength training in relation to SCD. Analyses were weighted; results are nationally representative. SCD was reported by 11.0% (SE: 0.2%) of middle-aged and older US adults. Three in 10 (29.1%; SE: 0.7%) of US middle-aged and older adults who reported SCD engaged in strength training 2+ times a week compared to 34.0% (SE: 0.3%) of US adults without SCD (aOR, 0.9; 95% CI: 0.9-1.0). While middle-aged and older US adults with SCD were less likely to strength train than those without SCD, only a third engaged in recommended strength training regardless of SCD status. Primary care providers should encourage strength training among middle-aged and older adults regardless of cognitive status.Item Critical Care Recovery Center: a model of agile implementation in intensive care unit (ICU) survivors(Cambridge University Press, 2020-12) Wang, Sophia; Hanneman, Philip; Xu, Chenjia; Gao, Sujuan; Allen, Duane; Golovyan, Dmitry; Kheir, You Na; Fowler, Nicole; Austrom, Mary; Khan, Sikandar; Boustani, Malaz; Khan, Babar; Psychiatry, School of MedicineBackground: As many as 70% of intensive care unit (ICU) survivors suffer from long-term physical, cognitive, and psychological impairments known as post-intensive care syndrome (PICS). We describe how the first ICU survivor clinic in the United States, the Critical Care Recovery Center (CCRC), was designed to address PICS using the principles of Agile Implementation (AI). Methods: The CCRC was designed using an eight-step process known as the AI Science Playbook. Patients who required mechanical ventilation or were delirious ≥48 hours during their ICU stay were enrolled in the CCRC. One hundred twenty subjects who completed baseline HABC-M CG assessments and had demographics collected were included in the analysis to identify baseline characteristics that correlated with higher HABC-M CG scores. A subset of patients and caregivers also participated in focus group interviews to describe their perceptions of PICS. Results: Quantitative analyses showed that the cognitive impairment was a major concern of caregivers. Focus group data also confirmed that caregivers of ICU survivors (n = 8) were more likely to perceive cognitive and mental health symptoms than ICU survivors (n = 10). Caregivers also described a need for ongoing psychoeducation about PICS, particularly cognitive and mental health symptoms, and for ongoing support from other caregivers with similar experiences. Conclusions: Our study demonstrated how the AI Science Playbook was used to build the first ICU survivor clinic in the United States. Caregivers of ICU survivors continue to struggle with PICS, particularly cognitive impairment, months to years after discharge. Future studies will need to examine whether the CCRC model of care can be adapted to other complex patient populations seen by health-care professionals.Item Digital Detection of Dementia (D Cubed) Trials(Oxford University Press, 2024-12-31) Boustani, Malaz; Fowler, Nicole; Medicine, School of MedicineAt Indiana University, we leveraged electronic health record (EHR) data and Machine Learning algorithms to develop a Passive Digital Marker (PDM) for dementia detection with 80% accuracy. At the University of Miami, we developed the Quick Dementia Rating Scale (QDRS) as a 2-3 minute patient-reported outcome tool with 85% accuracy for dementia diagnosis. Two pragmatic cluster-randomized controlled comparative effectiveness trials randomized primary care clinics to Usual care, PDM alone, and both the PDM and the QDRS. Trials recruited diverse rural, suburban and urban primary care practices located in central Indiana and south Florida. The positive results are communicated via the EHR only to clinicians within the PDM and PDM + QDRS clinics during an ambulatory primary care visit. The primary outcome measure is the annual rate of new documented dementia diagnosis. In the first year, the Indiana trial enrolled 5960 older patients with a mean age of 71.9 years and SD of 6.50, 61% were female and 51% were African American. In the clinics that were randomized to PDM + QDRS, there were 827 patients who completed at least one question on the QDRS. The Indiana trial used a non-interruptive Best Practice Alert (BPA) for the first year of operation. For the second year of operation, the trial coupled the BPA with an InBasket message to primary care physicians to overcome the shortcoming of the Non-interruptive nature of the BPA. We have created an IT implementation manual to deploy the PDM with minimum expertise.Item Feasibility and Acceptability of Using Plasma Biomarkers for Diagnosing Alzheimer’s Disease in Primary Care(Oxford University Press, 2023-12-21) Fowler, Nicole; Swartzell, Kristen; Hammers, Dustin; Brosch, Jared; Murray, James; Willis, Deanna; Medicine, School of MedicineBlood-based biomarkers (Aβ, P-tau, neurofilament light) are clinically available to aid in the diagnosis of Alzheimer’s disease and related dementias (ADRD). However, no research has examined the use of blood biomarkers to aid in the diagnosis of ADRD in primary care (PC). Our study will test feasibility and acceptability of implementing blood-based biomarkers for ADRD in PC. Participants include: all PC patients ≥65 years presenting to one of six PC clinics between 6/1/22 and 5/31/23 who score cognitively impaired on the Linus Health Digital Clock and Recall (DCR™), and PC providers (PCPs) of these patients. Patients will view a decision guide about biomarkers and complete the Concerns about Alzheimer’s Disease Dementia Scale, and the Future Time Perspective Scale and the Impact of Events Scale. These measures and the PHQ-9 and GAD-7 will be repeated within 2 weeks of results disclosure. PCPs will receive training on biomarker disclosure techniques and best practices. To date 9 PCPs have consented to provide the biomarker results disclosure and 11 have declined. Following completion of PCP consent (n=100), a total of 200 patients who failed the DCR are eligible to be approached for consent. By November 2023, we anticipate that 150 patients will have completed biomarker testing, and we will have examined the biomarker results in the context of patient neuropsychological and clinical data, comorbidities, and sociodemographic information. This study will provide information regarding feasibility and utility of ADRD biomarkers in PC and a preliminary analysis of biomarker results compared with the patients’ clinical profiles.Item Impact of a Driving Decision Aid on Decisional Conflict Among Older Adult Drivers and their Study Partners(Oxford University Press, 2022-12-20) Fowler, Nicole; Johnson, Rachel; Peterson, Ryan; Schroeder, Matthew; DiGuiseppi, Carolyn; Han, Duke; Hill, Linda; Betz, Marian; Medicine, School of MedicineForty-four million US licensed drivers are ≥65 years old and at higher crash risk. Decision-making about stopping or continuing driving is difficult and often involves family and friends. This study examines if decision conflict about changing driving habits is associated between older adult drivers and their study partners (SPs) (i.e., family member or friend). Data were from a multi-site trial assessing a driving decision aid. Decision conflict about stopping or continuing driving for drivers and their SPs were measured with the Decision Conflict Scale (DCS). Dyadic associations between drivers’ and SPs’ DCS scores pre- and post-decision aid implementation were analyzed using an actor-partner interdependence model. Among 228 driver-SP dyads, driver mean (SD) age was 77.1 (5.1) years; 50.0% female; 98.7% non-Hispanic; 94.7% white; and 97.8% urban-dwelling. SPs mean age was 66.1 years (13.9); 65.8% female; 95.6% non-Hispanic; 92.1% white; and commonly the driver’s spouse (54.6%) or adult child (21.1%). Most drivers (71.7%) and SPs (63.3%) had baseline DCS scores < 25 (drivers mean 18.5 (SD 12.3); SPs 20.5 (16.8)), suggesting low decision conflict. DCS was correlated within dyads at baseline (r=0.18, p < 0.01), and baseline DCS was associated with post-decision aid DCS (p < 0.001 for SPs [β=0.73] and drivers [β=0.73]). While SPs’ baseline DCS was not associated with drivers’ post-decision aid DCS, drivers’ baseline DCS and SPs’ post-decision DCS were (β=0.10; p=0.036). Higher decision conflict about driving felt by older drivers is frequently shared by their SPs, in whom decision conflict may persist even after a driving decision aid intervention.Item Implementation of a Digital Cognitive Screening Program for Dementia in Primary Care(Oxford University Press, 2023-12-21) Fowler, Nicole; Mullavey, Judy; Swartzell, Kristen; Hammers, Dustin; Brosch, Jared; Murray, James; Willis, Deanna; Medicine, School of MedicineEarly identification of Alzheimer’s disease and related dementias (ADRD) has become paramount given the emergence of disease modifying therapies. Integration of rapid, scalable tools to identify early cognitive impairment in primary care is essential because most at-risk individuals have limited access to specialty care. Yet, competing demands on primary care practices can make integration challenging. This demonstration project is being conducted to understand the feasibility, acceptability, and implementation of digital cognitive screening in primary care. Patients ≥65 years presenting to one of six primary care sites between 06/01/2022 and 06/30/2023 are asked to complete the Linus Health Digital Clock and Recall (DCR™) cognitive screening. Data regarding number of screening attempts that were refused, incomplete, or completed was collected. Results of the first completed screening-results were analyzed using descriptive statistics. As of 2/15/23, there are 3,920 screening attempts. DCR™ screenings were completed 40.8% of the time, refused 57.4%, and attempted but incomplete 1.8%. Thirteen-percent of attempts were positive for cognitive impairment, 37% were borderline, 44% were unimpaired, and 6% were unanalyzable. Average patient age is 73.2±6.0 years, 58% female, and 6% report less than high school education. Patients with positive screenings are older, slightly more female, and reported less education. Cognitive screening via DCR™ is ongoing and has been completed in nearly half of those approached, with half scoring cognitively impaired or borderline. This approach appears to have utility in early detection of cognitive impairment in primary care. By November 2023 we will have follow-up data for patients who screened positive.Item "Is it Time to Stop Driving?" A Randomized Trial of an Online Decision Aid for Older Drivers(Oxford University Press, 2022-12-20) Omeragic, Faris; Meador, Lauren; Fowler, Nicole; Johnson, Rachel; Boland, Elizabeth; Peterson, Ryan; Betz, Marian; Medicine, School of MedicineThe decision to stop or continue driving can be challenging for older adults. In a prospective two-arm randomized trial, we sought to test whether an online driving decision aid (DDA) would improve decision quality. We recruited 301 English-speaking licensed drivers, age ≥70 years, without significant cognitive impairment but with ≥1 diagnosis associated with increased likelihood of driving cessation, from clinics associated with study sites in three states. They were randomized to view 1) the online Healthwise® DDA for older adults addressing “Is it time to stop driving?”; or 2) a control condition of web-based information. Our primary outcome was decision conflict as estimated by the Decisional Conflict Scale (DCS; lower scores indicate higher quality). Secondary outcomes were knowledge and decision self-efficacy about driving decisions. We examined differences in post-randomization outcomes by study arm using generalized linear mixed-effects models with adjustment for site and pre-randomization scores. Intervention participants had a lower mean DCS score (12.3 DDA vs 15.2 control; p=0.017) and a higher mean knowledge score (88.9 DDA vs 79.9 control; p=0.038); we found no difference between groups in self-efficacy scores. The DDA had high acceptability; 86.9% of those who viewed it said they would recommend it to others in similar situations.The online Healthwise® DDA decreased decision conflict and increased knowledge in this sample of English-speaking, older adults without significant cognitive impairment. Use of such resources in clinical or community settings may support older adults as they transition from driving to other forms of mobility.Item Loneliness and Quality of Life in Older Adult Primary Care Patients(Oxford University Press, 2023-12-21) Williams-Farrelly, Monica; Schroeder, Matthew; Li, Claudia; Fowler, Nicole; Medicine, School of MedicineLoneliness, defined as the perceived discrepancy in an individual’s desired and actual social relationships, is common among older adults. Loneliness among older adult primary care patients is lacking, considering the implications it has on physical and mental health. Our objective was to determine the relationship between loneliness and quality of life (QOL) in older adult primary care patients. Data come from the Caregiver Outcomes of Alzheimer’s Disease Screening (COADS) study, an ongoing randomized controlled trial evaluating benefits and risks of Alzheimer’s disease and related dementias screening among older primary care patients and their family members. Loneliness (5-item NIH Toolbox), quality of life (QOL)—as measured by physical and mental health component scores— and depression (PHQ-9) and anxiety symptomatology (GAD-7) were measured among primary care patients aged 65 and older from April 2020 to September 2021. Spearman correlation analyses reveal that loneliness was moderately correlated with mental health (r(601) = -.43, p< 0.001), anxiety (r(601) =.44, p< 0.001), and depression (r(601) = .42, p< 0.001), while weakly correlated with physical health (r(601) = -.15, p< 0.001). After conducting unadjusted and adjusted linear regression models, we found that loneliness was associated with both lower mental (p< 0.001) and physical health component scores (p< 0.001). Furthermore, loneliness remained significantly associated with worse mental health when adjusting for depression, anxiety, sociodemographic characteristics, and comorbidity. Primary care providers should discuss loneliness with their older adult patients and provide resources to help patients develop and maintain meaningful social relationships.