Nudge Intervention for Dementia

Overseen By Julie Lauffenburger, PharmD, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must be taking: High-risk medications

Disqualifiers: Under 65, No dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a "nudge" can help doctors and patients with dementia discuss stopping risky medications. The "nudge" consists of a reminder sent to doctors and patients to address these medications during appointments. It targets individuals with dementia who regularly take certain high-risk medications. Those aged 65 or older with dementia and taking these medications might be suitable for this trial. As an unphased trial, it provides a unique opportunity to contribute to important research that could enhance communication and safety in dementia care.

Will I have to stop taking my current medications?

The trial involves a deprescribing nudge intervention, which suggests that participants may be encouraged to reduce or stop taking certain high-risk medications. However, the protocol does not specify if you must stop your current medications entirely.

What prior data suggests that this nudge intervention is safe for persons living with dementia?

Research shows that specific safety information for the Nudge Intervention for dementia is not yet available. Reports on side effects or negative reactions are currently lacking. However, this intervention is non-invasive, primarily involving reminders and information sent to doctors and patients, making it a very low-risk method.

Since the intervention does not involve new medications or medical procedures, serious safety concerns are unlikely. It focuses on enhancing communication between doctors and patients about discontinuing unnecessary medications, distinguishing it from many clinical trials that test new drugs or treatments.

While concrete data is not yet available, the intervention's focus on providing information and reminders suggests it is well-tolerated. Prospective participants should consult the research team for more details and to address any questions about what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nudge Intervention for dementia because it's a novel approach focusing on communication and decision-making rather than medication. Unlike standard treatments that often involve drugs to manage symptoms, this intervention uses enhanced alerts and reminders for primary care providers (PCPs) to discuss the risks of continued medication use with patients and their care partners. This method aims to empower patients and their families by facilitating informed conversations and potentially reducing unnecessary medication use. It's a shift toward more personalized and proactive care, which could lead to improved quality of life for people living with dementia.

What evidence suggests that this nudge intervention is effective for dementia?

Research shows that "nudges," small changes in how choices are presented, can effectively change behavior in healthcare. Studies have shown that most nudges are practical and work well in promoting health among older adults. This trial will test the Nudge Intervention's effectiveness in helping people with dementia. This approach involves reminders for both patients and caregivers to discuss medication use with doctors, aiming to reduce unnecessary medication and improve overall well-being in dementia patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Julie Lauffenburger, PharmD, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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

Primary care providers within Brigham and Women's Hospital primary care practices

My doctor has prescribed me a high-risk medication.

I am 65 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

PCPs and PLWD/care partners receive nudge interventions to discuss medication discontinuation

60 days

Multiple visits (in-person and electronic communication)

Follow-up

Participants are monitored for discontinuation or reduction in medication use

60 days

What Are the Treatments Tested in This Trial?

Interventions

• Nudge Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Nudge internvention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Published Research Related to This Trial

A preventive intervention program aimed at lowering dementia risk scores was found to be cost-effective, costing 21,974 SEK less than usual care while providing an additional 0.0511 quality-adjusted life years (QALYs) over 20 years.

The intervention showed a 67% probability of being cost-effective at a willingness-to-pay threshold of 600,000 SEK/year, suggesting strong potential for future research into preventive strategies for dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of a health intervention program with risk reductions for getting demented: results of a Markov model in a Swedish/Finnish setting. Zhang, Y., Kivipelto, M., Solomon, A., et al.[2011]

A randomized-controlled trial is being conducted to evaluate a behavioral economic intervention aimed at reducing unnecessary antipsychotic prescriptions for patients with Alzheimer's disease and related dementias, which are known to have limited efficacy and increased mortality risk.

The intervention includes alerts about mortality risks, non-pharmacological resources for caregivers, and default settings for prescriptions, combining behavioral economics principles to potentially improve physician prescribing patterns and reduce low-value care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mafi, JN., Walling, AM., Villaflores, C., et al.[2023]

The 'Active Brains' intervention, designed to promote physical activity, cognitive training, and healthy eating among older adults, was developed through extensive consultation and qualitative research with 52 participants, ensuring it meets the needs of both higher and lower cognitive performers.

Qualitative insights revealed that maintaining independence and enjoyment were key motivators for older adults to engage in the intervention, suggesting that a digitally delivered program with minimal support could be both acceptable and effective in reducing cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning and optimising a digital intervention to protect older adults' cognitive health. Essery, R., Pollet, S., Smith, KA., et al.[2022]

Population- and community-based interventions targeting modifiable risk factors for dementia, such as smoking, education, and physical inactivity, have been found to be highly cost-effective and can significantly reduce the risk of developing dementia.

The review included 45 studies from various countries, demonstrating that these interventions not only improve health outcomes but also have important economic implications, suggesting that investing in such strategies could lead to substantial savings in healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the cost-effectiveness of community and population interventions to reduce the modifiable risk factors for dementia. Walsh, S., Brain, J., Mukadam, N., et al.[2023]

In a study of 3,948 participants aged 50 and older, motivations for changing lifestyle to reduce dementia risk included having a family history of dementia and believing they already lead a healthy lifestyle.

Barriers to lifestyle change included competing health priorities and a lack of trust in the information received about dementia prevention, highlighting the need for trustworthy, evidence-based health campaigns tailored to individual motivations and circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing lifestyle for dementia risk reduction: Inductive content analysis of a national UK survey. Bosco, A., Jones, KA., Di Lorito, C., et al.[2020]

A systematic review of 39 studies found that nudges, particularly those that frame information, change default options, or enable choice, can effectively improve clinical decision-making among healthcare providers.

Most studies were conducted in the USA, with 36% being randomized controlled trials, indicating a need for more rigorous research to confirm the effectiveness of nudges compared to other interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of clinician-directed nudges in healthcare contexts. Last, BS., Buttenheim, AM., Timon, CE., et al.[2022]

In a study of 15,000 patients aged 60 and over with Alzheimer's disease, treatment persistence after one year was not significantly affected by the daily dosages of galantamine, donepezil, or rivastigmine.

However, patients taking a higher dose of memantine (20 mg) showed better treatment persistence compared to those on a lower dose (10 mg), suggesting that dosage may play a role in adherence for this specific medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Anti-Dementia Treatment Persistence and Daily Dosage of the First Prescription: A Retrospective Analysis in Neuropsychiatric Practices in Germany. Bohlken, J., Jacob, L., Kostev, K.[2018]

Descriptive prompts significantly improved activity attendance and engagement among 6 individuals with dementia, demonstrating their effectiveness as an intervention.

The study supports the use of antecedent interventions to promote positive behaviors in individuals with dementia, indicating a practical approach to enhance their participation in activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing activity attendance and engagement in individuals with dementia using descriptive prompts. Brenske, S., Rudrud, EH., Schulze, KA., et al.[2021]

Hospital-acquired complications like urinary tract infections, pressure areas, pneumonia, and delirium account for 6.4% of total hospital costs for patients over 50, with dementia patients experiencing these complications at a significantly higher rate (RR 2.5).

These complications lead to an eightfold increase in hospital length of stay and double the average episode cost, highlighting the need for improved care models to prevent such issues, especially in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. Bail, K., Goss, J., Draper, B., et al.[2022]

The Tailored Activities Program (TAP) is being tested in a randomized trial with 180 participant dyads in Australia to see if it can effectively reduce behavioral and psychological symptoms of dementia (BPSD) compared to a control group receiving phone-based education.

This study will not only assess the effectiveness of TAP in alleviating BPSD but also evaluate its cost-effectiveness, addressing a critical need for non-pharmacological interventions in dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Tailored Activities Program to reduce neuropsychiatric behaviors in dementia: an Australian protocol for a randomized trial to evaluate its effectiveness. O'Connor, CM., Clemson, L., Brodaty, H., et al.[2021]

A study involving 15 persons with dementia and 15 informal caregivers showed that individuals with dementia can effectively participate in discrete choice experiments (DCEs), completing an average of six choice tasks with at least three attributes, indicating their ability to express care preferences.

The dyadic DCE approach, where persons with dementia and caregivers participated together, allowed for better identification of shared and differing care preferences, suggesting it is a valuable method for reaching consensus in care decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic Discrete Choice Experiments Enable Persons with Dementia and Informal Caregivers to Participate in Health Care Decision Making: A Mixed Methods Study. Wammes, JD., Swait, JD., de Bekker-Grob, EW., et al.[2023]

Home visits significantly increased the willingness of study partners to allow their relatives with Alzheimer's disease to participate in clinical trials, with predicted participation rising from 17% to 27% when home visits were included.

Combining home visits with low risk and a higher chance of receiving the active treatment could boost willingness to participate to 60%, highlighting the importance of reducing travel hassles in recruiting participants, especially those with more severe Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How redesigning AD clinical trials might increase study partners' willingness to participate. Karlawish, J., Cary, MS., Rubright, J., et al.[2022]

Nudges can effectively change behavior by modifying the decision-making environment without limiting options or altering financial incentives, as shown in a review of 174 articles across various disciplines.

Nudges that automate decision-making processes have a greater average effect size (Cohen's d of 0.193) compared to other types of nudges, highlighting the importance of understanding which nudges are most effective for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging: Progress to date and future directions. Beshears, J., Kosowsky, H.[2021]

Citations

1. isrctn.com isrctn.com/pdf/23011121

A nudge-based intervention to promote older persons' ... Main outcomes were a composite patients' dementia prevention behaviors score comprising six lifestyle risk factors, cognition (composite memory– ...

2. withpower.com withpower.com/trial/phase-mild-cognitive-impairment-mci-4-2024-0e674

Nudge Intervention for Dementia Research shows that nudges, which are small changes in how choices are presented, can successfully change behavior in various areas, including healthcare. This ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748924002591

Using nudges to promote health among older adults Most, but not all, nudges have proven to be feasible and effective for health promotion among older adults.

4. frontiersin.org frontiersin.org/journals/health-services/articles/10.3389/frhs.2023.1212787/full

The methodology of the Agile Nudge University This paper describes the methodological tools, processes, and strategies developed for the Agile Nudge University.

5. dcricollab.dcri.duke.edu dcricollab.dcri.duke.edu/sites/impact/Knowledge%20Repository/2020-10-16-GR-Slides-IMPACT1.pdf

The AHRQ and Lancet Reports on Dementia Interventions Interventions for carers reduce depression and anxiety & may be cost-effective. • Keeping people with dementia physically healthy affects cognition. • ...

6. trialx.com trialx.com/clinical-trials/listings/317236/deprescribing-in-patients-living-with-dementia-with-caregiver-and-provider-nudges/

Deprescribing in Patients Living With Dementia ... The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that ...

7. nia.nih.gov nia.nih.gov/research/ongoing-AD-trials

NIA-Funded Active Alzheimer's and Related Dementias ... NIA is currently supporting over 400 active clinical trials on Alzheimer's disease and dementia in many areas of research. See the comprehensive list.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666142X24001140

Nudging in the nursing home: A qualitative interpretive study This study shows that experienced caregivers effectively use nudging to guide care routines, resulting in efficient care and better interactions.