Our Research Projects
High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial
Funding Agency: National Institute on Aging
Status: Ongoing
Project Overview: Individuals with Alzheimer disease (AD) and Alzheimer disease-related dementias (ADRD) may be at increased risk for adverse outcomes relating to inappropriate prescribing of certain high-risk medications, including antipsychotics, sedative-hypnotics, and strong anticholinergic agents. The objective of this pragmatic randomized trial was to evaluate the effect of a patient/caregiver and prescriber-mailed educational intervention on potentially inappropriate prescribing to patients with AD or ADRD. The trial was conducted in two national health plans. The trial included patients with AD or ADRD and use of any of 3 drug classes targeted for deprescribing (antipsychotics, sedative-hypnotics, or strong anticholinergics). Patients were randomized to 1 of 3 arms: (1) a mailing of educational materials specific to the medication targeted for deprescribing to both the patient and their prescribing clinician; (2) a mailing to the prescribing clinician only; or (3) a usual care arm. Among 12 787 patients included in the modified intention-to-treat analysis, 8742 (68.4%) were female, and the mean (SD) age was 77.3 (9.4) years. The cumulative incidence of being dispensed a medication targeted for deprescribing was 76.7% (95% CI, 75.4-78.0) in the patient and prescriber mailing group, 77.9% (95% CI, 76.5-79.1) in the prescriber mailing only group, and 77.5% (95% CI, 76.2-78.8) in the usual care group. Hazard ratios were 0.99 (95% CI, 0.94-1.04) for the patient and prescriber group and 1.00 (95% CI, 0.96-1.06) for the prescriber only group compared with the usual care group. These findings suggest medication-specific educational mailings targeting patients with AD or ADRD and their clinicians are not effective in reducing the use of high-risk medications. A follow-up trial, building off of these findings, is ongoing.
Reference: Singh S, Li X, Cocoros NM, Antonelli MT, Avula R, Crawford SL, Dashevsky I, Fouayzi H, Harkins TP, Mazor KM, Michnick AI, Parlett L, Paullin M, Platt R, Rochon PA, Saphirak C, Si M, Zhou Y, Gurwitz JH. High-Risk Medications in Persons Living with Dementia: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1426-1433. doi: 10.1001/jamainternmed.2024.5632. PMID: 39432286; PMCID: PMC11581620.
Generating real-world evidence in early Alzheimer's disease: Considerations for applying the target trial emulation framework to study the safety of anti-amyloid therapies
Funding Agency: National Institute on Aging
Status: Complete
Project Overview: Anti-amyloid beta monoclonal antibodies (anti-Aβ mAbs) have received approval from the US Food and Drug Administration for the treatment of patients with mild cognitive impairment or mild dementia due to Alzheimer's disease (collectively known as early AD) based on evidence from clinical trials. However, whether findings from these trials are generalizable to the real world is uncertain. We need reliable evidence on the real-world safety of these treatments to inform decision making for clinicians, patients, and caregivers. Using lecanemab as an exemplar, we outlined the key considerations in designing and implementing an observational study on safety and utilization outcomes using established administrative healthcare claims data sources with the target trial emulation framework. The target trial emulation framework is a rigorous causal inference framework that minimizes common biases in observational studies. The proposed approach can be applied to evaluation of additional mAbs as they become available.
Reference: Li X, Singh S, Rasouli B, Lyons J, Cocoros NM, Platt R, Abi-Elias I, Gurwitz JH. Generating real-world evidence in early Alzheimer's disease: Considerations for applying the target trial emulation framework to study the safety of anti-amyloid therapies. Alzheimers Dement (N Y). 2025 Apr 15;11(2):e70080. doi: 10.1002/trc2.70080. PMID: 40242567; PMCID: PMC12000246.
HOPE (HOlistic Partner Engagement) Research Lab Projects
Title: Enhancing the Engagement in Shared Decision Making for Stroke Prevention among Older Adults with Atrial Fibrillation and Multiple Chronic Conditions
Funding Source: University of Massachusetts Chan Center for Clinical and Translational Science KL2 Faculty Career Development Program
Status: Ongoing
Project Overview: The complexities of managing multimorbidity, including receiving conflicting therapeutic recommendations that may not align with patient priorities and goals of care, often lead to reduced treatment uptake, adherence, and poor clinical outcomes. Despite these challenges, very limited attention has been given to understand how older adults with multimorbidity, and their caregivers engage in the complex decision-making for stroke prevention. The study aims to identify the factors that influence engagement in the complex decision-making for stroke prevention in older adults with atrial fibrillation and multimorbidity, from the perspectives of key partners including patients, caregivers, and clinicians. This work will refine and adapt the Patient Priorities Care (PPC) model to identify what matters most to older adults with atrial fibrillation and multimorbidity to ensure that the decision-making for stroke prevention aligns with patients' healthcare priorities, preferences, and treatment goals. Study participants will be recruited from an ongoing NIH-funded study: Supporting Use of Anticoagulation through Provider Prompting about Oral Anticoagulation Therapy for Atrial Fibrillation (SUPPORT-AF IV; R01HL155343 PI). Through this award, we will explore the factors that may influence engagement in stroke prevention decision-making for older adults with atrial fibrillation and multimorbidity by conducting in-depth qualitative interviews with key partners including patients, caregivers, clinicians (Aim 1). Additionally, we will refine and adapt the PPC framework aimed at improving engagement in priorities aligned decision-making for stroke prevention in older adults with atrial fibrillation and multimorbidity through a user-centered and iterative process with key partners (Aim 2). She will then evaluate the feasibility and acceptability of the adapted PPC framework for priority-aligned decision-making for stroke prevention (Aim 3). Based on these findings, we will develop a patient-centered intervention that enhances engagement in shared decision-making for stroke prevention by considering patient priorities, preferences, goals of care, and promotes caregiver involvement.
Title: Association of Health Belief Variables, Religiosity, and Spirituality with Anticoagulation Use in Older Adults with Atrial Fibrillation
Funding Source: National Heart, Lung, and Blood Institute (NHLBI)
Status: Ongoing
Project Overview: More than six million Americans suffer from atrial fibrillation (AF), a heart rhythm abnormality that contributes to significant morbidity and mortality. AF accounts for approximately 1 in 5 cases of ischemic strokes resulting in permanent disability for a majority of older adults. Although oral anticoagulation (AC) is effective for AF-related stroke prevention, only 60% of eligible AF patients use AC. This is particularly true among older adults with reduced access to healthcare, for whom AC use is lower and stroke rates are higher. Understanding the barriers that contribute to this gap in AC use and adherence is critical to developing strategies to help decrease AF morbidity and mortality rates in underserved populations. This project focuses on older individuals over age 65 with AF to examine the barriers to AC use. This work will be a natural extension of the parent R01 SUPPORT-AF IV: Supporting Use of AC through Provider Prompting about Oral Anticoagulation Therapy for AF. Now in its third year, SUPPORT-AF IV has already established a cohort of individuals and their providers from two distinct health systems in Massachusetts and Florida. In the current project, we will perform telephone surveys to measure the association of health belief variables (risk perception, trust in providers, beliefs about the effectiveness of AC) + religiosity and spirituality on AC use in older adults with AF on and off AC and established in care at our participating sites. Subsequently, a subset analysis will be conducted to examine the differential association of surveyed variables with AC across varying groups of older adults.