Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges

NCT06347172 | Completed DMC

• 2 other identifiers: 2024p000278U54AG063546
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Alzheimer Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Composite of the percentage of eligible PCPs or their PLWD/care partners who view or click on information

  This will be the primary progression criteria for the study and measured and evaluated separately by patient and provider.

  On or before the primary care provider visit

Secondary Outcomes (2)

• Number of nudges that fire as intended: Fidelity

  On the primary care provider visit

• Discontinuation or prescribed reduction in medication

  Within 60 days after the primary care provider visit

Study Arms (1)

Nudge internvention

EXPERIMENTAL

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.

Behavioral: Nudge Intervention

Interventions

Nudge Intervention BEHAVIORAL

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.

Nudge internvention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Providers within Brigham and Women's Hospital primary care practices
• Having prescribed at least one of the high-risk medications of interest
• Eligible patients will be identified through this providers within the health care system.
• At least 65 years of age
• Prescribed at least 90 pills of one of the high-risk medications of interest in the last 180 days in the EHR system, which most guidelines consider chronic use, and have a diagnosis of dementia in the EHR.

Sponsors & Collaborators

• Brown University: collaborator
• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Julie Lauffenburger, PharmD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: August 1, 2024
• Primary Completion: October 14, 2025
• Study Completion: December 15, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)