Nudge Intervention for Dementia

Overseen by Julie Lauffenburger, PharmD, PhD

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?

Research shows that nudges, which are small changes in how choices are presented, can successfully change behavior in various areas, including healthcare. This suggests that using nudges might help improve decision-making in dementia care, potentially leading to better outcomes. ^{1 2 3 4 5}

What safety data exists for the Nudge Intervention for Dementia?

The provided research articles do not contain specific safety data for the Nudge Intervention for Dementia or similar interventions under different names. ^{5 6 7 8 9}

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. ^{1 10 11 12 13}

Research Team

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.

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 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.

Participant Groups

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+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Brown University

Collaborator

Trials

480

Recruited

724,000+

Mukesh Jain

Brown University

Chief Medical Officer since 2022

MD from Harvard Medical School

Christina H. Paxson

Brown University

Chief Executive Officer since 2012

PhD in Economics from Columbia University

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Systematic review of clinician-directed nudges in healthcare contexts. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Nudging: Progress to date and future directions. [2021]

4. Netherlands 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. [2018]

5. Netherlands 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. [2011]

6. Ireland 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. [2022]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

How redesigning AD clinical trials might increase study partners' willingness to participate. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Changing lifestyle for dementia risk reduction: Inductive content analysis of a national UK survey. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Planning and optimising a digital intervention to protect older adults' cognitive health. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Increasing activity attendance and engagement in individuals with dementia using descriptive prompts. [2021]

13. Netherlands 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. [2023]