Nudge Intervention for Dementia
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Brigham and Women's Hospital
Must be taking: High-risk medications
Disqualifiers: Under 65, No dementia, others
No Placebo Group
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.
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 data supports the effectiveness of the Nudge Intervention treatment for dementia?
What safety data exists for the Nudge Intervention for Dementia?
How is the Nudge Intervention treatment for dementia different from other treatments?
The Nudge Intervention for dementia is unique because it focuses on using behavioral prompts to increase activity attendance and engagement, rather than relying on medication. This approach is part of a broader trend towards non-drug interventions that aim to improve quality of life and reduce symptoms by encouraging positive behaviors.110111213
Research Team
JL
Julie Lauffenburger, PharmD, PhD
Principal Investigator
Brigham and Women's Hospital
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.
Primary care providers within Brigham and Women's Hospital primary care practices
I am 65 years old or older.
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Trial Timeline
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
Treatment Details
Interventions
- Nudge Intervention (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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 Hospital
Lead Sponsor
Trials
1694
Patients Recruited
14,790,000+
National Institute on Aging (NIA)
Collaborator
Trials
1841
Patients Recruited
28,150,000+
Brown University
Collaborator
Trials
480
Patients Recruited
724,000+
Findings from Research
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 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]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Nudging: Progress to date and future directions.Beshears, J., Kosowsky, H.[2021]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
References
Use of the Tailored Activities Program to reduce neuropsychiatric behaviors in dementia: an Australian protocol for a randomized trial to evaluate its effectiveness. [2021]
Systematic review of clinician-directed nudges in healthcare contexts. [2022]
Nudging: Progress to date and future directions. [2021]
Association between Anti-Dementia Treatment Persistence and Daily Dosage of the First Prescription: A Retrospective Analysis in Neuropsychiatric Practices in Germany. [2018]
Cost-effectiveness of a health intervention program with risk reductions for getting demented: results of a Markov model in a Swedish/Finnish setting. [2011]
A systematic review of the cost-effectiveness of community and population interventions to reduce the modifiable risk factors for dementia. [2023]
The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. [2022]
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]
How redesigning AD clinical trials might increase study partners' willingness to participate. [2022]
Changing lifestyle for dementia risk reduction: Inductive content analysis of a national UK survey. [2020]
Planning and optimising a digital intervention to protect older adults' cognitive health. [2022]
Increasing activity attendance and engagement in individuals with dementia using descriptive prompts. [2021]
Dyadic Discrete Choice Experiments Enable Persons with Dementia and Informal Caregivers to Participate in Health Care Decision Making: A Mixed Methods Study. [2023]