Trial Summary
What is the purpose of this trial?The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified.
What safety data exists for the Nudge Intervention for Dementia?The provided research does not directly address safety data for the Nudge Intervention for Dementia. The studies focus on cost-effectiveness, economic evaluations, and interventions to reduce modifiable risk factors for dementia, but do not provide specific safety data for the Nudge Intervention. Further research or specific studies on the safety of this intervention would be needed to answer this question.2351113
Is the Nudge Intervention treatment a promising treatment for dementia?Yes, the Nudge Intervention treatment is promising because it can increase activity attendance and engagement in people with dementia, which helps improve their behavior and quality of life.1471012
What data supports the idea that Nudge Intervention for Dementia is an effective treatment?The available research shows that nudges, which are small changes in how choices are presented, can successfully influence behavior in various areas, including healthcare. However, there is no specific data provided here about Nudge Intervention for Dementia being effective. The research mentions the effectiveness of nudges in general, but not specifically for dementia. In comparison, the Tailored Activities Program (TAP) has shown promising results in reducing problem behaviors in people with dementia, suggesting it might be more directly supported by evidence for this condition.34689
Do I need to stop taking my current medications for this trial?The trial focuses on a deprescribing intervention, which suggests that you may need to stop or reduce certain high-risk medications. However, the protocol does not specify exact details, so it's best to discuss with the trial coordinators.
Eligibility Criteria
This trial is for individuals aged 65 or older with dementia, who have been prescribed at least 90 pills of certain high-risk medications in the past six months. Participants are identified through primary care providers within Brigham and Women's Hospital practices.Inclusion Criteria
My doctor has prescribed me a high-risk medication.
I am 65 years old or older.
I have dementia and have been prescribed 90 or more high-risk pills in the last 6 months.
Treatment Details
The study tests a 'nudge intervention' aimed to help doctors consider stopping (deprescribing) certain medications that may not be beneficial for patients living with dementia. The goal is to see if this approach can work on a large scale.
1Treatment groups
Experimental Treatment
Group I: Nudge internventionExperimental Treatment1 Intervention
PCPs will receive an enhanced EHR alert (nudge) that triggers when a PCP opens an encounter for an eligible patient living with dementia (PLWD). The nudge will provide information about the risks of continued medication use as well as tips and tools to help providers discuss medication discontinuation with patients and care partners. Additionally, the providers will receive a brief message in their in-basket 10 days before the patient's appointment as a reminder.
Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mass General BrighamBoston, MA
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
National Institute on Aging (NIA)Collaborator
Brown UniversityCollaborator
References
Increasing activity attendance and engagement in individuals with dementia using descriptive prompts. [2021]The effects of providing descriptive prompts to increase activity attendance and engagement in 6 individuals with dementia were evaluated using a reversal design. The results showed that providing descriptive prompts increased activity attendance and engagement for all participants. The results support the use of antecedent interventions for increasing appropriate behavior by individuals with dementia.
How redesigning AD clinical trials might increase study partners' willingness to participate. [2022]Timely recruiting and retaining participants into Alzheimer disease (AD) clinical trials is a challenge. We used conjoint analysis to identify how alterations in attributes of clinical trial design improve willingness to participate: risk, home visits, car service, or increased chance of receiving intervention.
Cost-effectiveness of a health intervention program with risk reductions for getting demented: results of a Markov model in a Swedish/Finnish setting. [2011]Risk scores based on modifiable factors have recently been developed for dementia. This study aims to estimate the cost-effectiveness of a potential preventive intervention program meant to lower the score related to increased dementia risk. Analyses were based on a Markov model adapted to Swedish circumstances. Risk score categories and risk probabilities were derived from the Cardiovascular Risk Factors, Aging and Incidence of Dementia (CAIDE) study in Finland. Figures of costs, utilities, and mortality were obtained from literature or databases. One-way sensitivity analysis and probabilistic sensitivity analysis were carried out to investigate the robustness of the model and to identify which model inputs had most impact on the results. In the base case, the usual care had a cost of 621,000 SEK and utilities of 11.8438 quality-adjusted life year (QALYs). The intervention had a cost of 599, 026 SEK and utilities of 11.8950 QALYs. The cost was 21,974 SEK lower in the intervention with 0.0511 QALYs gained over a 20 years horizon, indicating absolute dominance. The support for cost-effectiveness was insensitive to changes in the value of QALY for demented, mortality, and risk of dementia. If the intervention program was assumed to run every year, the incremental cost-effectiveness ratio did not show absolute dominance but was still under the willingness-to-pay level. The probabilistic sensitivity analysis indicated cost effectiveness in 67% of the samplings given a willingness-to-pay level of 600,000 SEK/year. This is a promising outlook for future research on preventive interventions in dementia, emphasizing the need of conducting multi-domain randomized trials.
Use of the Tailored Activities Program to reduce neuropsychiatric behaviors in dementia: an Australian protocol for a randomized trial to evaluate its effectiveness. [2021]Behavioral and psychological symptoms of dementia (BPSD) are often considered to be the greatest challenge in dementia care, leading to increased healthcare costs, caregiver burden, and placement into care facilities. With potential for pharmacological intervention to exacerbate behaviors or even lead to mortality, the development and rigorous testing of non-pharmacological interventions is vital. A pilot of the Tailored Activities Program (TAP) for reducing problem behaviors in people with dementia was conducted in the United States with promising results. This randomized trial will investigate the effectiveness of TAP for reducing the burden of BPSD on persons with dementia and family caregivers within an Australian population. This trial will also examine the cost-effectiveness and willingness to pay for TAP compared with a control group.
The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. [2022]Increased length of stay and high rates of adverse clinical events in hospitalised patients with dementia is stimulating interest and debate about which costs may be associated and potentially avoided within this population.
Association between Anti-Dementia Treatment Persistence and Daily Dosage of the First Prescription: A Retrospective Analysis in Neuropsychiatric Practices in Germany. [2018]High adherence and persistence are important for the efficacy of anti-dementia treatments.
Changing lifestyle for dementia risk reduction: Inductive content analysis of a national UK survey. [2020]To explore what motivates individuals to change their behaviour to reduce their risk of dementia.
Nudging: Progress to date and future directions. [2021]Nudges influence behavior by changing the environment in which decisions are made, without restricting the menu of options and without altering financial incentives. This paper assesses past empirical research on nudging and provides recommendations for future work in this area by discussing examples of successful and unsuccessful nudges and by analyzing 174 articles that estimate nudge treatment effects. Researchers in disciplines spanning the behavioral sciences, using varied data sources, have documented that many different types of nudges succeed in changing behavior in a wide range of domains. Nudges that automate some aspect of the decision-making process have an average effect size, measured by Cohen's d, that is 0.193 larger than that of other nudges. Our analyses point to the need for future research to pay greater attention to (1) determining which types of nudges tend to be most impactful; (2) using field and laboratory research approaches as complementary methods; (3) measuring long-run effects of nudges; (4) considering effects of nudges on non-targeted outcomes; and (5) examining interaction effects among nudges and other interventions.
Systematic review of clinician-directed nudges in healthcare contexts. [2022]Nudges are interventions that alter the way options are presented, enabling individuals to more easily select the best option. Health systems and researchers have tested nudges to shape clinician decision-making with the aim of improving healthcare service delivery. We aimed to systematically study the use and effectiveness of nudges designed to improve clinicians' decisions in healthcare settings.
Planning and optimising a digital intervention to protect older adults' cognitive health. [2022]By 2050, worldwide dementia prevalence is expected to triple. Affordable, scalable interventions are required to support protective behaviours such as physical activity, cognitive training and healthy eating. This paper outlines the theory-, evidence- and person-based development of 'Active Brains': a multi-domain digital behaviour change intervention to reduce cognitive decline amongst older adults.
A systematic review of the cost-effectiveness of community and population interventions to reduce the modifiable risk factors for dementia. [2023]Dementia is a leading global cause of morbidity and mortality. Evidence suggests that tackling modifiable lifecourse risk factors could prevent or delay a significant proportion of cases. Population- and community-based approaches change societal conditions such that everyone across a given community is more likely to live more healthily. We systematically reviewed economic studies of population- and community-based interventions to reduce modifiable lifecourse risk factors for dementia. We searched Medline, EMBASE, Web of Science, CINAHL, PsycInfo, Scopus, Econlit, ERIC, the British Education Index, and Google, on 03/03/2022. We included cost-effectiveness, cost-benefit, and cost-utility studies, provided that the direct outcome of the intervention was a modifiable risk factor for dementia, and was measured empirically. Quality appraisal was completed using the Consensus on Health Economic Criteria checklist. A narrative synthesis was performed. We included 45 studies, from 22,749 records identified. Included studies targeted smoking (n = 15), education (n = 10), physical inactivity (n = 9), obesity (n = 5), air pollution (n = 2), traumatic brain injury (n = 1), and multiple risk factors (n = 3). Intervention designs included changing the physical/food environment (n = 13), mass media programmes (n = 11), reducing financial barriers or increasing resources (n = 10), whole-community approaches (n = 6), and legislative change (n = 3). Overall, interventions were highly cost-effective and/or cost-saving, particularly those targeting smoking, educational attainment, and physical inactivity. Effects were observed in high- (e.g. USA and UK) and low- and middle-income (e.g. Mexico, Tanzania, Thailand) countries. Further research into the direct effects of targeting these risk factors on future dementia prevalence will have important economic, social and policy implications.
Dyadic Discrete Choice Experiments Enable Persons with Dementia and Informal Caregivers to Participate in Health Care Decision Making: A Mixed Methods Study. [2023]Discrete choice experiments (DCEs) may facilitate persons with dementia and informal caregivers to state care preferences. DCEs can be cognitively challenging for persons with dementia.
A pragmatic parallel arm randomized-controlled trial of a multi-pronged electronic health record-based clinical decision support tool protocol to reduce low-value antipsychotic prescriptions among older adults with Alzheimer's and related dementias. [2023]Among patients with Alzheimer's disease and its related dementias (ADRD) with behavioral disturbances, antipsychotic prescriptions have limited efficacy and increase the risk of death. Yet, physicians continue to routinely prescribe low-value antipsychotic medications for behavioral disturbances among patients with ADRD. We designed a pragmatic randomized-controlled trial to measure the impact of a behavioral economic electronic health record (EHR) clinical decision support (CDS) intervention to reduce physician prescriptions of new antipsychotic medications among patients with ADRD. Utilizing a pragmatic parallel arm randomized-controlled trial design, the study will randomize eligible physicians from a large academic health system to either receive a EHR CDS intervention or not (control) when they prescribe a new antipsychotic medication during visits with patients with ADRD. The intervention will include three components: 1) alerts prescribers that antipsychotic prescriptions increase mortality risk (motivating physicians' intrinsic desire for non-malfeasance); 2) offers non-pharmacological behavioral resources for caregivers; 3) auto-defaults the prescription to contain the lowest dose and number of pill-days (n = 30) without refills if the prescriber does not cancel the order (appealing to default bias). Over 1 year, we will compare the cumulative total of new antipsychotic pill-days prescribed (primary outcome) by physicians in the intervention group versus in the control group. The study protocol meets international SPIRIT guidelines. Behavioral economics, or the study of human behavior as a function of more than rational incentives, considering a whole host of cognitive and social psychological preferences, tendencies, and biases, is increasingly recognized as an important conceptual framework to improve physician behavior. This pragmatic trial is among the first to combine two distinct behavioral economic principles, a desire for non-malfeasance and default bias, to improve physician prescribing patterns for patients with ADRD. We anticipate this trial will substantially advance understanding of how behavioral-economic informed EHR CDS tools can potentially reduce harmful, low-value care among patients with ADRD.