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OpenTrials
Completed

NCT Number: NCT06347172

Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass General Brigham

Boston, Massachusetts, 02120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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, up to 10 Days

    Time frame: On or before the primary care provider visit, up to 10 days

    This is the primary progression criteria for the study, measured on the patient level. This is measured as a composite of the number of eligible PCPs or their PLWD/care partners who view or click on information on or before the primary care provider visit, up to 10 days

Secondary outcomes

  1. Number of Patients With Nudges That Fire as Intended: Fidelity

    Time frame: On the primary care provider visit date

    Number of patients who had provider EHR alerts that fired as intended, measured among patients who had a completed target visit (n=99) within EHR data.

  2. Discontinuation or Prescribed Reduction in Medication

    Time frame: Within 60 days on or 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 using data from the EHR system, measured on the patient-level as the number of patients who have medications discontinued or have a prescribed reduction.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Brown University
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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