Deprescribing in Patients Living with Dementia with Caregiver and Provider Nudges

Not Applicable

Recruiting

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia
• Interventions: Behavioral: Nudge Intervention

• Registration Number: NCT06347172
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-04
• Study Start: 2024-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-08-31
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nudge internvention	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.

Primary Outcome Measures

Name	Time	Method
Composite of the percentage of eligible PCPs or their PLWD/care partners who view or click on information	On or before the primary care provider visit	This will be the primary progression criteria for the study and measured and evaluated separately by patient and provider.

Secondary Outcome Measures

Name	Time	Method
Number of nudges that fire as intended: Fidelity	On the primary care provider visit	Number of nudges that fired as intended
Discontinuation or prescribed reduction in medication	Within 60 days after the primary care provider visit	Discontinuation or prescribed reduction in dose of at least one high-risk medication of interest within 60 days after the visit.

Trial Locations

Locations (1)

Mass General Brigham; 🇺🇸 Boston, Massachusetts, United States