Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges

Alzheimer Disease Clinical Trial

Official title:

Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347172
• Other study ID #: 2024p000278
• Secondary ID: U54AG063546
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2024
• Est. completion date: February 15, 2025

Study information

• Verified date: May 2024
• Source: Brigham and Women's Hospital
• Contact: Julie Lauffenburger, PharmD, PhD
• Phone: 617-525-8865
• Email: jlauffenburger[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: February 15, 2025
• Est. primary completion date: December 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Primary care providers will be the primary unit of identification and randomization.

Primary care providers 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.

Patient inclusion criteria:

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Brown University, National Institute on Aging (NIA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of nudges that fire as intended: Fidelity	Number of nudges that fired as intended	On the primary care provider visit
Secondary	Discontinuation or prescribed reduction in medication	Discontinuation or prescribed reduction in dose of at least one high-risk medication of interest within 60 days after the visit.	Within 60 days after the primary care provider visit