Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges

NCT ID: NCT06347172

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-12-15

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.

Detailed Description

The PCP nudge will consist of: a 'pre-commitment' EHR nudge triggered when a PCP opens a patient encounter (i.e., prompt to first have a discussion and then later deprescribe) and a brief message within the in-basket prior to upcoming visits including information about their patient. The patient living with dementia (PLWD)/care partner nudge will include an electronic message delivered prior to upcoming visits (in their primary language recorded in the EHR) that includes a recommendation for the PLWD (and care partner, if available) to discuss medications with the PCP at the visit.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Dementia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Nudge internvention

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.

Group Type: EXPERIMENTAL

Nudge Intervention

Intervention Type: 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.

Interventions

Nudge 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julie Lauffenburger

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Lauffenburger, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Mass General Brigham

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

U54AG063546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024p000278

Identifier Type: -

Identifier Source: org_study_id